Trial Outcomes & Findings for Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus (NCT NCT04510090)

NCT ID: NCT04510090

Last Updated: 2025-08-08

Results Overview

To assess safety and tolerability of EP547 following single and multiple oral administration

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

89 participants

Primary outcome timeframe

Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)

Results posted on

2025-08-08

Participant Flow

This study was conducted on 85 subjects at 4 sites in Australia and New Zealand. This study consisted of 7 segments: single ascending dose in healthy subjects (SAD-HS), multiple ascending dose in healthy subjects (MAD-HS), food effect in healthy subjects (FE-HS), single dose in subjects with cholestatic pruritus (SD-CP), multiple dose in subjects with cholestatic pruritus (MD-CP), single dose in subjects with uremic pruritus (SD-UP), and multiple dose in subjects with uremic pruritus (MD-UP).

A total of 89 subjects (85 unique subjects) participated in the study. SAD-HS n=40 MAD-HS n=24 FE-HS n=5 SD-CP n=5 SD-UP n=6 MD-CP n=3 MD-UP N=6 (4 subjects participated in both SD-UP and MD-UP)

Participant milestones

Participant milestones
Measure
Placebo
Participants in all segments received placebo matched to EP547.
EP547 20 mg
Participants in MD-UP segment received 20 mg of EP547 QD for 7 days.
EP547 25 mg
Participants in SAD-HS segment received a single 25 mg dose of EP547. Participants in MAD-HS segment received 25 mg of EP547 QD for 7 days.
EP547 30 mg
Participants in MD-CP segment received 30 mg of EP547 QD for 7 days.
EP547 75 mg
Participants in SAD-HS segment received a single 75 mg dose of EP547. Participants in MAD-HS segment received 75 mg of EP547 QD for 7 days. Participants in FE-HS segment received a single 75 mg dose of EP547 under fed or fasted condition, separated by a washout period. Participants in SD-CP and SD-UP segments received a single 75 mg dose of EP547.
EP547 225 mg
Participants in SAD-HS segment received a single 225 mg dose of EP547. Participants in MAD-HS segment received 225 mg of EP547 QD for 7 days.
EP547 450 mg
Participants in SAD-HS segment received a single 450 mg dose of EP547.
EP547 675 mg
Participants in SAD-HS segment received a single 675 mg dose of EP547.
SAD-HS
STARTED
10
0
6
0
6
6
6
6
SAD-HS
COMPLETED
10
0
6
0
6
6
6
6
SAD-HS
NOT COMPLETED
0
0
0
0
0
0
0
0
MAD-HS
STARTED
6
0
6
0
6
6
0
0
MAD-HS
COMPLETED
6
0
6
0
6
6
0
0
MAD-HS
NOT COMPLETED
0
0
0
0
0
0
0
0
FE-HS
STARTED
0
0
0
0
5
0
0
0
FE-HS
COMPLETED
0
0
0
0
4
0
0
0
FE-HS
NOT COMPLETED
0
0
0
0
1
0
0
0
SD-CP
STARTED
0
0
0
0
5
0
0
0
SD-CP
COMPLETED
0
0
0
0
5
0
0
0
SD-CP
NOT COMPLETED
0
0
0
0
0
0
0
0
SD-UP
STARTED
0
0
0
0
6
0
0
0
SD-UP
COMPLETED
0
0
0
0
6
0
0
0
SD-UP
NOT COMPLETED
0
0
0
0
0
0
0
0
MD-CP
STARTED
1
0
0
2
0
0
0
0
MD-CP
COMPLETED
1
0
0
2
0
0
0
0
MD-CP
NOT COMPLETED
0
0
0
0
0
0
0
0
MD-UP
STARTED
2
4
0
0
0
0
0
0
MD-UP
COMPLETED
2
4
0
0
0
0
0
0
MD-UP
NOT COMPLETED
0
0
0
0
0
0
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Placebo
Participants in all segments received placebo matched to EP547.
EP547 20 mg
Participants in MD-UP segment received 20 mg of EP547 QD for 7 days.
EP547 25 mg
Participants in SAD-HS segment received a single 25 mg dose of EP547. Participants in MAD-HS segment received 25 mg of EP547 QD for 7 days.
EP547 30 mg
Participants in MD-CP segment received 30 mg of EP547 QD for 7 days.
EP547 75 mg
Participants in SAD-HS segment received a single 75 mg dose of EP547. Participants in MAD-HS segment received 75 mg of EP547 QD for 7 days. Participants in FE-HS segment received a single 75 mg dose of EP547 under fed or fasted condition, separated by a washout period. Participants in SD-CP and SD-UP segments received a single 75 mg dose of EP547.
EP547 225 mg
Participants in SAD-HS segment received a single 225 mg dose of EP547. Participants in MAD-HS segment received 225 mg of EP547 QD for 7 days.
EP547 450 mg
Participants in SAD-HS segment received a single 450 mg dose of EP547.
EP547 675 mg
Participants in SAD-HS segment received a single 675 mg dose of EP547.
FE-HS
Withdrawal by Subject
0
0
0
0
1
0
0
0

Baseline Characteristics

This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo
n=19 Participants
Participants in all segments received placebo matched to EP547.
EP547 20 mg
n=4 Participants
Participants in MD-UP segment received 20 mg of EP547 QD for 7 days.
EP547 25 mg
n=12 Participants
Participants in SAD-HS segment received a single 25 mg dose of EP547. Participants in MAD-HS segment received 25 mg of EP547 QD for 7 days.
EP547 30 mg
n=2 Participants
Participants in MD-CP segment received 30 mg of EP547 QD for 7 days.
EP547 75 mg
n=28 Participants
Participants in SAD-HS segment received a single 75 mg dose of EP547. Participants in MAD-HS segment received 75 mg of EP547 QD for 7 days. Participants in FE-HS segment received a single 75 mg dose of EP547 under fed or fasted condition, separated by a washout period. Participants in SD-CP and SD-UP segments received a single 75 mg dose of EP547.
EP547 225 mg
n=12 Participants
Participants in SAD-HS segment received a single 225 mg dose of EP547. Participants in MAD-HS segment received 225 mg of EP547 QD for 7 days.
EP547 450 mg
n=6 Participants
Participants in SAD-HS segment received a single 450 mg dose of EP547.
EP547 675 mg
n=6 Participants
Participants in SAD-HS segment received a single 675 mg dose of EP547.
Total
n=89 Participants
Total of all reporting groups
Age, Continuous
SAD-HS
27.3 Years
STANDARD_DEVIATION 9.9 • n=10 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
30.7 Years
STANDARD_DEVIATION 12.3 • n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
32.5 Years
STANDARD_DEVIATION 9.1 • n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
32.7 Years
STANDARD_DEVIATION 11.1 • n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
30.2 Years
STANDARD_DEVIATION 4.2 • n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
36.2 Years
STANDARD_DEVIATION 4.2 • n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
31.2 Years
STANDARD_DEVIATION 9.36 • n=40 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Age, Continuous
MAD-HS
32.8 Years
STANDARD_DEVIATION 12.2 • n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
30.0 Years
STANDARD_DEVIATION 13.5 • n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
42.0 Years
STANDARD_DEVIATION 14.1 • n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
36.3 Years
STANDARD_DEVIATION 16.3 • n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
35.3 Years
STANDARD_DEVIATION 13.94 • n=24 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Age, Continuous
FE-HS
40.4 Years
STANDARD_DEVIATION 13.4 • n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
40.4 Years
STANDARD_DEVIATION 13.39 • n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Age, Continuous
SD-CP
58.8 Years
STANDARD_DEVIATION 15.7 • n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
58.8 Years
STANDARD_DEVIATION 15.69 • n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Age, Continuous
SD-UP
39.8 Years
STANDARD_DEVIATION 10.3 • n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
39.8 Years
STANDARD_DEVIATION 10.26 • n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Age, Continuous
MD-CP
63.0 Years
STANDARD_DEVIATION NA • n=1 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
46.0 Years
STANDARD_DEVIATION 2.8 • n=2 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
51.7 Years
STANDARD_DEVIATION 10.02 • n=3 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Age, Continuous
MD-UP
74.5 Years
STANDARD_DEVIATION 4.9 • n=2 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
41.8 Years
STANDARD_DEVIATION 6.9 • n=4 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
52.7 Years
STANDARD_DEVIATION 17.88 • n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Sex: Female, Male
SAD-HS · Female
8 Participants
n=10 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
4 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
5 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
4 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
3 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
25 Participants
n=40 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Sex: Female, Male
SAD-HS · Male
2 Participants
n=10 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
2 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
2 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
3 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
5 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
15 Participants
n=40 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Sex: Female, Male
MAD-HS · Female
1 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
3 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
2 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
7 Participants
n=24 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Sex: Female, Male
MAD-HS · Male
5 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
3 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
4 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
5 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
17 Participants
n=24 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Sex: Female, Male
FE-HS · Female
3 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
3 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Sex: Female, Male
FE-HS · Male
2 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
2 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Sex: Female, Male
SD-CP · Female
3 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
3 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Sex: Female, Male
SD-CP · Male
2 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
2 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Sex: Female, Male
SD-UP · Female
2 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
2 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Sex: Female, Male
SD-UP · Male
4 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
4 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Sex: Female, Male
MD-CP · Female
1 Participants
n=1 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=2 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
2 Participants
n=3 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Sex: Female, Male
MD-CP · Male
0 Participants
n=1 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=2 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=3 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Sex: Female, Male
MD-UP · Female
1 Participants
n=2 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=4 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
2 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Sex: Female, Male
MD-UP · Male
1 Participants
n=2 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
3 Participants
n=4 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
4 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Ethnicity (NIH/OMB)
SAD-HS · Hispanic or Latino
3 Participants
n=10 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
3 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
2 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
9 Participants
n=40 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Ethnicity (NIH/OMB)
SAD-HS · Not Hispanic or Latino
7 Participants
n=10 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
6 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
6 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
3 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
3 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
4 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
29 Participants
n=40 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Ethnicity (NIH/OMB)
SAD-HS · Unknown or Not Reported
0 Participants
n=10 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
2 Participants
n=40 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Ethnicity (NIH/OMB)
MAD-HS · Hispanic or Latino
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=24 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Ethnicity (NIH/OMB)
MAD-HS · Not Hispanic or Latino
6 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
6 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
5 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
5 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
22 Participants
n=24 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Ethnicity (NIH/OMB)
MAD-HS · Unknown or Not Reported
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=24 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Ethnicity (NIH/OMB)
FE-HS · Hispanic or Latino
0 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Ethnicity (NIH/OMB)
FE-HS · Not Hispanic or Latino
5 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
5 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Ethnicity (NIH/OMB)
FE-HS · Unknown or Not Reported
0 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Ethnicity (NIH/OMB)
SD-CP · Hispanic or Latino
0 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Ethnicity (NIH/OMB)
SD-CP · Not Hispanic or Latino
5 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
5 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Ethnicity (NIH/OMB)
SD-CP · Unknown or Not Reported
0 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Ethnicity (NIH/OMB)
SD-UP · Hispanic or Latino
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Ethnicity (NIH/OMB)
SD-UP · Not Hispanic or Latino
6 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
6 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Ethnicity (NIH/OMB)
SD-UP · Unknown or Not Reported
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Ethnicity (NIH/OMB)
MD-CP · Hispanic or Latino
0 Participants
n=1 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=2 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=3 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Ethnicity (NIH/OMB)
MD-CP · Not Hispanic or Latino
1 Participants
n=1 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=2 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
2 Participants
n=3 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Ethnicity (NIH/OMB)
MD-CP · Unknown or Not Reported
0 Participants
n=1 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=2 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=3 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Ethnicity (NIH/OMB)
MD-UP · Hispanic or Latino
0 Participants
n=2 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=4 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Ethnicity (NIH/OMB)
MD-UP · Not Hispanic or Latino
2 Participants
n=2 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
4 Participants
n=4 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
6 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Ethnicity (NIH/OMB)
MD-UP · Unknown or Not Reported
0 Participants
n=2 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=4 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Race/Ethnicity, Customized
SAD-HS Asian
2 Participants
n=10 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
2 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
6 Participants
n=40 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Race/Ethnicity, Customized
SAD-HS Black or African American
0 Participants
n=10 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=40 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Race/Ethnicity, Customized
SAD-HS White
5 Participants
n=10 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
6 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
5 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
3 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
2 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
4 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
25 Participants
n=40 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Race/Ethnicity, Customized
SAD-HS American Indian or Alaska Native
1 Participants
n=10 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=40 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Race/Ethnicity, Customized
SAD-HS Native Hawaiian or Pacific Islander
0 Participants
n=10 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
2 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
2 Participants
n=40 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Race/Ethnicity, Customized
SAD-HS Other
2 Participants
n=10 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
2 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
2 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
8 Participants
n=40 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Race/Ethnicity, Customized
MAD-HS Asian
2 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
2 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
5 Participants
n=24 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Race/Ethnicity, Customized
MAD-HS Black or African American
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=24 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Race/Ethnicity, Customized
MAD-HS White
3 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
4 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
3 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
2 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
12 Participants
n=24 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Race/Ethnicity, Customized
MAD-HS American Indian or Alaska Native
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=24 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Race/Ethnicity, Customized
MAD-HS Native Hawaiian or Pacific Islander
1 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
2 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
4 Participants
n=24 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Race/Ethnicity, Customized
MAD-HS Other
0 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
2 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
1 Participants
n=6 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
4 Participants
n=24 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Race/Ethnicity, Customized
FE-HS Asian
0 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Race/Ethnicity, Customized
FE-HS Black or African American
0 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Race/Ethnicity, Customized
FE-HS White
5 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
5 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Race/Ethnicity, Customized
FE-HS American Indian or Native American
0 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Race/Ethnicity, Customized
FE-HS Native Hawaiian or Pacific Islander
0 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
Race/Ethnicity, Customized
FE-HS Other
0 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).
0 Participants
n=5 Participants • This study consisted of 7 segments: 1) single ascending dose in healthy subjects (SAD-HS), 2) multiple ascending dose in healthy subjects (MAD-HS), 3) food effect in healthy subjects (FE-HS), 4) single dose in subjects with cholestatic pruritus (SD-CP), 5) multiple dose in subjects with cholestatic pruritus (MD-CP), 6) single dose in subjects with uremic pruritus (SD-UP), and 7) multiple dose in subjects with uremic pruritus (MD-UP).

PRIMARY outcome

Timeframe: Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)

Population: All safety analyses were based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo).

To assess safety and tolerability of EP547 following single and multiple oral administration

Outcome measures

Outcome measures
Measure
Placebo
n=19 Participants
Participants in all segments received placebo matched to EP547.
EP547 20 mg
n=4 Participants
Participants in MD-UP segment received 20 mg of EP547 QD for 7 days.
EP547 25 mg
n=12 Participants
Participants in SAD-HS segment received a single 25 mg dose of EP547. Participants in MAD-HS segment received 25 mg of EP547 QD for 7 days.
EP547 30 mg
n=2 Participants
Participants in MD-CP segment received 30 mg of EP547 QD for 7 days.
EP547 75 mg
n=28 Participants
Participants in SAD-HS segment received a single 75 mg dose of EP547. Participants in MAD-HS segment received 75 mg of EP547 QD for 7 days. Participants in FE-HS segment received a single 75 mg dose of EP547 under fed or fasted condition, separated by a washout period. Participants in SD-CP and SD-UP segments received a single 75 mg dose of EP547.
EP547 225 mg
n=12 Participants
Participants in SAD-HS segment received a single 225 mg dose of EP547. Participants in MAD-HS segment received 225 mg of EP547 QD for 7 days.
EP547 450 mg
n=6 Participants
Participants in SAD-HS segment received a single 450 mg dose of EP547.
EP547 675 mg
n=6 Participants
Participants in SAD-HS segment received a single 675 mg dose of EP547.
Incidence of Adverse Events
FE-HS : Any TEAE
3 participants
Incidence of Adverse Events
SAD-HS : Any TEAE
5 participants
5 participants
5 participants
3 participants
3 participants
4 participants
Incidence of Adverse Events
SAD-HS : Any Serious TEAE
0 participants
0 participants
0 participants
0 participants
0 participants
0 participants
Incidence of Adverse Events
SAD-HS : Any drug-related TEAE
0 participants
2 participants
1 participants
0 participants
1 participants
2 participants
Incidence of Adverse Events
SAD-HS : Any TEAE leading to discontinuation of study drug
0 participants
0 participants
0 participants
0 participants
0 participants
0 participants
Incidence of Adverse Events
MAD-HS : Any TEAE
3 participants
6 participants
4 participants
4 participants
Incidence of Adverse Events
MAD-HS : Any Serious TEAE
0 participants
0 participants
0 participants
0 participants
Incidence of Adverse Events
MAD-HS : Any drug-related TEAE
2 participants
5 participants
3 participants
2 participants
Incidence of Adverse Events
MAD-HS : Any TEAE leading to discontinuation of study drug
0 participants
0 participants
0 participants
0 participants
Incidence of Adverse Events
FE-HS : Any Serious TEAE
0 participants
Incidence of Adverse Events
FE-HS : Any drug-related TEAE
1 participants
Incidence of Adverse Events
FE-HS : Any TEAE leading to discontinuation of study drug
0 participants
Incidence of Adverse Events
SD-CP : Any TEAE
4 participants
Incidence of Adverse Events
SD-CP : Any Serious TEAE
0 participants
Incidence of Adverse Events
SD-CP : Any drug-related TEAE
0 participants
Incidence of Adverse Events
SD-CP : Any TEAE leading to discontinuation of study drug
0 participants
Incidence of Adverse Events
SD-UP : Any TEAE
1 participants
Incidence of Adverse Events
SD-UP : Any Serious TEAE
0 participants
Incidence of Adverse Events
SD-UP : Any drug-related TEAE
0 participants
Incidence of Adverse Events
SD-UP : Any TEAE leading to discontinuation of study drug
0 participants
Incidence of Adverse Events
MD-CP : Any TEAE
1 participants
1 participants
Incidence of Adverse Events
MD-CP : Any Serious TEAE
0 participants
0 participants
Incidence of Adverse Events
MD-CP : Any drug-related TEAE
0 participants
1 participants
Incidence of Adverse Events
MD-CP : Any TEAE leading to discontinuation of study drug
0 participants
0 participants
Incidence of Adverse Events
MD-UP : Any TEAE
1 participants
2 participants
Incidence of Adverse Events
MD-UP : Any Serious TEAE
0 participants
0 participants
Incidence of Adverse Events
MD-UP : Any drug-related TEAE
0 participants
0 participants
Incidence of Adverse Events
MD-UP : Any TEAE leading to discontinuation of study drug
0 participants
0 participants

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, and 12 hours post-dose on Day 1

Population: All PK analyses were based on the PK Population. For non-FE segments, the PK Population included all subjects who received ≥1 dose of EP547 and for whom a sufficient number of samples were available to determine at least 1 PK parameter. For FE segment, the PK Population included all randomized subjects who received ≥1 dose of EP547, had no protocol deviations affecting the PK variables of EP547, and for whom a sufficient number of samples were available to determine at least 1 PK parameter.

To evaluate the pharmacokinetics of single dose of EP547

Outcome measures

Outcome measures
Measure
Placebo
Participants in all segments received placebo matched to EP547.
EP547 20 mg
n=4 Participants
Participants in MD-UP segment received 20 mg of EP547 QD for 7 days.
EP547 25 mg
n=12 Participants
Participants in SAD-HS segment received a single 25 mg dose of EP547. Participants in MAD-HS segment received 25 mg of EP547 QD for 7 days.
EP547 30 mg
n=2 Participants
Participants in MD-CP segment received 30 mg of EP547 QD for 7 days.
EP547 75 mg
n=28 Participants
Participants in SAD-HS segment received a single 75 mg dose of EP547. Participants in MAD-HS segment received 75 mg of EP547 QD for 7 days. Participants in FE-HS segment received a single 75 mg dose of EP547 under fed or fasted condition, separated by a washout period. Participants in SD-CP and SD-UP segments received a single 75 mg dose of EP547.
EP547 225 mg
n=12 Participants
Participants in SAD-HS segment received a single 225 mg dose of EP547. Participants in MAD-HS segment received 225 mg of EP547 QD for 7 days.
EP547 450 mg
n=6 Participants
Participants in SAD-HS segment received a single 450 mg dose of EP547.
EP547 675 mg
n=6 Participants
Participants in SAD-HS segment received a single 675 mg dose of EP547.
Maximum Plasma Concentration [Cmax] After Single Dose of EP547
SAD-HS
1421.0 ng/mL
Geometric Coefficient of Variation 29.4
6309.6 ng/mL
Geometric Coefficient of Variation 19.3
17232.6 ng/mL
Geometric Coefficient of Variation 17.6
27799.2 ng/mL
Geometric Coefficient of Variation 29.8
36352.2 ng/mL
Geometric Coefficient of Variation 38.3
Maximum Plasma Concentration [Cmax] After Single Dose of EP547
MAD-HS
1506.6 ng/mL
Geometric Coefficient of Variation 38.4
3973.4 ng/mL
Geometric Coefficient of Variation 35.5
16954.8 ng/mL
Geometric Coefficient of Variation 35.0
Maximum Plasma Concentration [Cmax] After Single Dose of EP547
FE-HS (Fasted)
5780.3 ng/mL
Geometric Coefficient of Variation 22.9
Maximum Plasma Concentration [Cmax] After Single Dose of EP547
FE-HS (Fed)
3504.0 ng/mL
Geometric Coefficient of Variation 30.0
Maximum Plasma Concentration [Cmax] After Single Dose of EP547
SD-CP
5019.5 ng/mL
Geometric Coefficient of Variation 31.7
Maximum Plasma Concentration [Cmax] After Single Dose of EP547
SD-UP
3483.3 ng/mL
Geometric Coefficient of Variation 75.0
Maximum Plasma Concentration [Cmax] After Single Dose of EP547
MD-CP
1728.5 ng/mL
Geometric Coefficient of Variation 93.7
Maximum Plasma Concentration [Cmax] After Single Dose of EP547
MD-UP
781.0 ng/mL
Geometric Coefficient of Variation 54.6

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, and 24 hours post-dose on Day 7

Population: All PK analyses were based on the PK Population. For non-FE segments, the PK Population included all subjects who received ≥1 dose of EP547 and for whom a sufficient number of samples were available to determine at least 1 PK parameter. For FE segment, the PK Population included all randomized subjects who received ≥1 dose of EP547, had no protocol deviations affecting the PK variables of EP547, and for whom a sufficient number of samples were available to determine at least 1 PK parameter.

To evaluate the pharmacokinetics of multiple doses of EP547

Outcome measures

Outcome measures
Measure
Placebo
Participants in all segments received placebo matched to EP547.
EP547 20 mg
n=4 Participants
Participants in MD-UP segment received 20 mg of EP547 QD for 7 days.
EP547 25 mg
n=6 Participants
Participants in SAD-HS segment received a single 25 mg dose of EP547. Participants in MAD-HS segment received 25 mg of EP547 QD for 7 days.
EP547 30 mg
n=2 Participants
Participants in MD-CP segment received 30 mg of EP547 QD for 7 days.
EP547 75 mg
n=6 Participants
Participants in SAD-HS segment received a single 75 mg dose of EP547. Participants in MAD-HS segment received 75 mg of EP547 QD for 7 days. Participants in FE-HS segment received a single 75 mg dose of EP547 under fed or fasted condition, separated by a washout period. Participants in SD-CP and SD-UP segments received a single 75 mg dose of EP547.
EP547 225 mg
n=6 Participants
Participants in SAD-HS segment received a single 225 mg dose of EP547. Participants in MAD-HS segment received 225 mg of EP547 QD for 7 days.
EP547 450 mg
Participants in SAD-HS segment received a single 450 mg dose of EP547.
EP547 675 mg
Participants in SAD-HS segment received a single 675 mg dose of EP547.
Maximum Plasma Concentration [Cmax] After Multiple Doses of EP547
MAD-HS
2834.7 ng/mL
Geometric Coefficient of Variation 16.4
8760.7 ng/mL
Geometric Coefficient of Variation 27.4
29613.1 ng/mL
Geometric Coefficient of Variation 21.0
Maximum Plasma Concentration [Cmax] After Multiple Doses of EP547
MD-CP
3421.0 ng/mL
Geometric Coefficient of Variation 27.8
Maximum Plasma Concentration [Cmax] After Multiple Doses of EP547
MD-UP
3192.7 ng/mL
Geometric Coefficient of Variation 49.5

Adverse Events

SAD-HS Placebo

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

MAD-HS Placebo

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

MD-CP Placebo

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

MD-UP Placebo

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

MD-UP EP547 20 mg

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

SAD-HS EP547 25 mg

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

MAD-HS EP547 25 mg

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

MD-CP EP547 30 mg

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

SAD-HS EP547 75 mg

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

MAD-HS EP547 75 mg

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

FE-HS EP547 75 mg

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

SD-CP EP547 75 mg

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

SD-UP EP547 75 mg

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

SAD-HS EP547 225 mg

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

MAD-HS EP547 225 mg

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

SAD-HS EP547 450 mg

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

SAD-HS EP547 675 mg

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
SAD-HS Placebo
n=10 participants at risk
Participants in all segments received placebo matched to EP547.
MAD-HS Placebo
n=6 participants at risk
Participants in all segments received placebo matched to EP547.
MD-CP Placebo
n=1 participants at risk
Participants in this segment received placebo matched to EP547.
MD-UP Placebo
n=2 participants at risk
Participants in this segment received placebo matched to EP547.
MD-UP EP547 20 mg
n=4 participants at risk
Participants in this segment received 20 mg of EP547 QD for 7 days.
SAD-HS EP547 25 mg
n=6 participants at risk
Participants in this segment received a single 25 mg dose of EP547.
MAD-HS EP547 25 mg
n=6 participants at risk
Participants in this segment received 25 mg of EP547 QD for 7 days.
MD-CP EP547 30 mg
n=2 participants at risk
Participants in this segment received 30 mg of EP547 QD for 7 days.
SAD-HS EP547 75 mg
n=6 participants at risk
Participants in this segment received a single 75 mg dose of EP547.
MAD-HS EP547 75 mg
n=6 participants at risk
Participants in this segment received 75 mg of EP547 QD for 7 days.
FE-HS EP547 75 mg
n=5 participants at risk
Participants in this segment received a single 75 mg dose of EP547 under fed or fasted condition, separated by a washout period.
SD-CP EP547 75 mg
n=5 participants at risk
Participants in this segment received a single 75 mg dose of EP547.
SD-UP EP547 75 mg
n=6 participants at risk
Participants in this segment received a single 75 mg dose of EP547.
SAD-HS EP547 225 mg
n=6 participants at risk
Participants in this segment received a single 225 mg dose of EP547.
MAD-HS EP547 225 mg
n=6 participants at risk
Participants in this segment received 225 mg of EP547 QD for 7 days.
SAD-HS EP547 450 mg
n=6 participants at risk
Participants in this segment received a single 450 mg dose of EP547.
SAD-HS EP547 675 mg
n=6 participants at risk
Participants in this segment received a single 675 mg dose of EP547.
Metabolism and nutrition disorders
Appetite disorder
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Blood and lymphatic system disorders
Iron deficiency anaemia
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
25.0%
1/4 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Nervous system disorders
Headache
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
33.3%
2/6 • Number of events 2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
33.3%
2/6 • Number of events 2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
83.3%
5/6 • Number of events 6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
50.0%
1/2 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
33.3%
2/6 • Number of events 2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
33.3%
2/6 • Number of events 2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
40.0%
2/5 • Number of events 2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
50.0%
3/6 • Number of events 3 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Nervous system disorders
Presyncope
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Nervous system disorders
Dysgeusia
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Nervous system disorders
Hypoaesthesia
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Nervous system disorders
Dizziness
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
100.0%
1/1 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Nervous system disorders
Head discomfort
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
50.0%
1/2 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Nervous system disorders
Somnolence
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
20.0%
1/5 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Eye disorders
Eyelid skin dryness
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
10.0%
1/10 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
20.0%
1/5 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Gastrointestinal disorders
Nausea
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Gastrointestinal disorders
Diarrhoea
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
33.3%
2/6 • Number of events 2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Gastrointestinal disorders
Abdominal distension
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
33.3%
2/6 • Number of events 2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Gastrointestinal disorders
Dyspepsia
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Gastrointestinal disorders
Salivary gland pain
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Gastrointestinal disorders
Lip dry
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
33.3%
2/6 • Number of events 2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Skin and subcutaneous tissue disorders
Urticaria
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
50.0%
1/2 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Skin and subcutaneous tissue disorders
Dermatitis contact
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
20.0%
1/5 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
20.0%
1/5 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
10.0%
1/10 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Renal and urinary disorders
Pollakiuria
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Renal and urinary disorders
Dysuria
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
25.0%
1/4 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
General disorders
Application site dermatitis
10.0%
1/10 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
General disorders
Application site irritation
10.0%
1/10 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
General disorders
Application site laceration
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
General disorders
Vessel puncture site swelling
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
General disorders
Fatigue
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
33.3%
2/6 • Number of events 2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
General disorders
Application site rash
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
General disorders
Vessel puncture site bruise
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
General disorders
Vessel puncture site pain
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
General disorders
Vessel puncture site haematoma
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
100.0%
1/1 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Injury, poisoning and procedural complications
Muscle strain
10.0%
1/10 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Injury, poisoning and procedural complications
Contusion
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
100.0%
1/1 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Injury, poisoning and procedural complications
Procedural pain
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Injury, poisoning and procedural complications
Skin abrasion
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
16.7%
1/6 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Injury, poisoning and procedural complications
Thermal burn
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
20.0%
1/5 • Number of events 1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
Injury, poisoning and procedural complications
Vascular access site pain
0.00%
0/10 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/1 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/4 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
40.0%
2/5 • Number of events 2 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/5 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.
0.00%
0/6 • Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Adverse events reporting based on the Safety Population, which included all subjects who received at least one dose of study drug (EP547 or placebo). All AE summaries restricted to treatment-emergent adverse events only.

Additional Information

Kristin Taylor, Sr VP, Head of Clinical Development

Escient Pharmaceuticals

Phone: (858) 617-8220

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60