Trial Outcomes & Findings for A Study of LY3522348 in Healthy Participants (NCT NCT04559568)
NCT ID: NCT04559568
Last Updated: 2025-11-04
Results Overview
An SAE is any untoward medical occurrence temporally associated with the use of study intervention that results in death is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation as determined by investigator. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious adverse events, regardless of causality, will be reported in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
65 participants
Primary outcome timeframe
Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
Results posted on
2025-11-04
Participant Flow
Participant milestones
| Measure |
Part B: 50 mg LY3522348
50 mg LY3522348 administered orally once daily on Days 1-14.
|
Part B: 120 mg LY3522348
120 mg LY3522348 administered orally once daily on Days 1-14.
|
Part B: 290 mg LY3522348 + Midazolam
290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.
|
Part A: Placebo
A single dose of Placebo administered orally on Day 1.
|
Part A: 5 mg LY3522348
A single dose of 5 mg LY3522348 administered orally on Day 1.
|
Part A: 15 mg LY3522348
A single dose of 15 mg LY3522348 administered orally on Day 1.
|
Part A: 50 mg LY3522348
A single dose of 50 mg LY3522348 administered orally on Day 1.
|
Part A: 150 mg LY3522348
A single dose of 150 mg LY3522348 administered orally on Day 1.
|
Part A: 380 mg LY3522348
A single dose of 380 mg LY3522348 administered orally on Day 1.
|
Part B: Placebo
Placebo administered orally once daily on Days 1-14.
|
Part B: Placebo + Midazolam
Placebo administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
7
|
10
|
6
|
6
|
6
|
6
|
6
|
4
|
2
|
|
Overall Study
Received At Least 1 Dose of Study Drug
|
6
|
6
|
7
|
10
|
6
|
6
|
6
|
6
|
6
|
4
|
2
|
|
Overall Study
COMPLETED
|
6
|
5
|
6
|
10
|
6
|
6
|
6
|
6
|
6
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part B: 50 mg LY3522348
50 mg LY3522348 administered orally once daily on Days 1-14.
|
Part B: 120 mg LY3522348
120 mg LY3522348 administered orally once daily on Days 1-14.
|
Part B: 290 mg LY3522348 + Midazolam
290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.
|
Part A: Placebo
A single dose of Placebo administered orally on Day 1.
|
Part A: 5 mg LY3522348
A single dose of 5 mg LY3522348 administered orally on Day 1.
|
Part A: 15 mg LY3522348
A single dose of 15 mg LY3522348 administered orally on Day 1.
|
Part A: 50 mg LY3522348
A single dose of 50 mg LY3522348 administered orally on Day 1.
|
Part A: 150 mg LY3522348
A single dose of 150 mg LY3522348 administered orally on Day 1.
|
Part A: 380 mg LY3522348
A single dose of 380 mg LY3522348 administered orally on Day 1.
|
Part B: Placebo
Placebo administered orally once daily on Days 1-14.
|
Part B: Placebo + Midazolam
Placebo administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY3522348 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part A: Placebo
n=10 Participants
A single dose of Placebo administered orally on Day 1.
|
Part A: 5 mg LY3522348
n=6 Participants
A single dose of 5 mg LY3522348 administered orally on Day 1.
|
Part A: 15 mg LY3522348
n=6 Participants
A single dose of 15 mg LY3522348 administered orally on Day 1.
|
Part A: 50 mg LY3522348
n=6 Participants
A single dose of 50 mg LY3522348 administered orally on Day 1.
|
Part A: 150 mg LY3522348
n=6 Participants
A single dose of 150 mg LY3522348 administered orally on Day 1.
|
Part A: 380 mg LY3522348
n=6 Participants
A single dose of 380 mg LY3522348 administered orally on Day 1.
|
Part B: Placebo
n=4 Participants
Placebo administered orally once daily on Days 1-14.
|
Part B: Placebo + Midazolam
n=2 Participants
Placebo administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.
|
Part B: 50 mg LY3522348
n=6 Participants
50 mg LY3522348 administered orally once daily on Days 1-14.
|
Part B: 120 mg LY3522348
n=6 Participants
120 mg LY3522348 administered orally once daily on Days 1-14.
|
Part B: 290 mg LY3522348 + Midazolam
n=7 Participants
290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
50.2 years
n=15 Participants
|
53.5 years
n=161 Participants
|
48.8 years
n=100 Participants
|
56.0 years
n=3 Participants
|
57.0 years
n=8 Participants
|
31.0 years
n=7 Participants
|
47.5 years
n=8 Participants
|
57.0 years
n=8 Participants
|
43.0 years
n=8 Participants
|
36.3 years
n=68 Participants
|
45.0 years
n=4 Participants
|
47.3 years
n=44 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=15 Participants
|
4 Participants
n=161 Participants
|
5 Participants
n=100 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=68 Participants
|
1 Participants
n=4 Participants
|
26 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=68 Participants
|
6 Participants
n=4 Participants
|
39 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
2 Participants
n=100 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=68 Participants
|
1 Participants
n=4 Participants
|
23 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=15 Participants
|
4 Participants
n=161 Participants
|
4 Participants
n=100 Participants
|
5 Participants
n=3 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=68 Participants
|
6 Participants
n=4 Participants
|
42 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
3 Participants
n=100 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=68 Participants
|
4 Participants
n=4 Participants
|
26 Participants
n=44 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=15 Participants
|
5 Participants
n=161 Participants
|
3 Participants
n=100 Participants
|
5 Participants
n=3 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=68 Participants
|
3 Participants
n=4 Participants
|
39 Participants
n=44 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=44 Participants
|
PRIMARY outcome
Timeframe: Part A: Baseline up to Day 14; Part B: Baseline up to Day 28Population: All enrolled participants, irrespective of the completion of all protocol requirements.
An SAE is any untoward medical occurrence temporally associated with the use of study intervention that results in death is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation as determined by investigator. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious adverse events, regardless of causality, will be reported in the Reported Adverse Events module.
Outcome measures
| Measure |
Part A: Placebo
n=10 Participants
A single dose of Placebo administered orally on Day 1.
|
Part A: 5 mg LY3522348
n=6 Participants
A single dose of 5 mg LY3522348 administered orally on Day 1.
|
Part A: 15 mg LY3522348
n=6 Participants
A single dose of 15 mg LY3522348 administered orally on Day 1.
|
Part A: 50 mg LY3522348
n=6 Participants
A single dose of 50 mg LY3522348 administered orally on Day 1.
|
Part A: 150 mg LY3522348
n=6 Participants
A single dose of 150 mg LY3522348 administered orally on Day 1.
|
Part A: 380 mg LY3522348
n=6 Participants
A single dose of 380 mg LY3522348 administered orally on Day 1.
|
Part B: Placebo
n=4 Participants
Placebo administered orally once daily on Days 1-14.
|
Part B: Placebo + Midazolam
n=2 Participants
Placebo administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.
|
Part B: 50 mg LY3522348
n=6 Participants
50 mg LY3522348 administered orally once daily on Days 1-14.
|
Part B: 120 mg LY3522348
n=6 Participants
120 mg LY3522348 administered orally once daily on Days 1-14.
|
Part B: 290 mg LY3522348 + Midazolam
n=7 Participants
290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours post Day 1 dose)Population: All enrolled participants in Part A who received at least one dose of study drug and have evaluable PK data.
PK: AUC(0-tlast) of LY3522348
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
A single dose of Placebo administered orally on Day 1.
|
Part A: 5 mg LY3522348
n=6 Participants
A single dose of 5 mg LY3522348 administered orally on Day 1.
|
Part A: 15 mg LY3522348
n=6 Participants
A single dose of 15 mg LY3522348 administered orally on Day 1.
|
Part A: 50 mg LY3522348
n=6 Participants
A single dose of 50 mg LY3522348 administered orally on Day 1.
|
Part A: 150 mg LY3522348
n=6 Participants
A single dose of 150 mg LY3522348 administered orally on Day 1.
|
Part A: 380 mg LY3522348
A single dose of 380 mg LY3522348 administered orally on Day 1.
|
Part B: Placebo
Placebo administered orally once daily on Days 1-14.
|
Part B: Placebo + Midazolam
Placebo administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.
|
Part B: 50 mg LY3522348
50 mg LY3522348 administered orally once daily on Days 1-14.
|
Part B: 120 mg LY3522348
120 mg LY3522348 administered orally once daily on Days 1-14.
|
Part B: 290 mg LY3522348 + Midazolam
290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC(0-tlast)) of LY3522348
|
0.330 microgram*hour/milliliter (μg*h/mL)
Geometric Coefficient of Variation 25
|
1.27 microgram*hour/milliliter (μg*h/mL)
Geometric Coefficient of Variation 30
|
3.37 microgram*hour/milliliter (μg*h/mL)
Geometric Coefficient of Variation 20
|
9.45 microgram*hour/milliliter (μg*h/mL)
Geometric Coefficient of Variation 37
|
25.3 microgram*hour/milliliter (μg*h/mL)
Geometric Coefficient of Variation 24
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24 hours post Day 1 dose); Day 14 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 144 hours post Day 14 dose)Population: All enrolled participants in Part B who received at least one dose of study drug and have evaluable PK data.
PK: AUC(0-tlast) of LY3522348
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
A single dose of Placebo administered orally on Day 1.
|
Part A: 5 mg LY3522348
n=6 Participants
A single dose of 5 mg LY3522348 administered orally on Day 1.
|
Part A: 15 mg LY3522348
n=6 Participants
A single dose of 15 mg LY3522348 administered orally on Day 1.
|
Part A: 50 mg LY3522348
A single dose of 50 mg LY3522348 administered orally on Day 1.
|
Part A: 150 mg LY3522348
A single dose of 150 mg LY3522348 administered orally on Day 1.
|
Part A: 380 mg LY3522348
A single dose of 380 mg LY3522348 administered orally on Day 1.
|
Part B: Placebo
Placebo administered orally once daily on Days 1-14.
|
Part B: Placebo + Midazolam
Placebo administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.
|
Part B: 50 mg LY3522348
50 mg LY3522348 administered orally once daily on Days 1-14.
|
Part B: 120 mg LY3522348
120 mg LY3522348 administered orally once daily on Days 1-14.
|
Part B: 290 mg LY3522348 + Midazolam
290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC(0-tlast)) of LY3522348
Day 14
|
6.00 μg*h/mL
Geometric Coefficient of Variation 29
|
14.4 μg*h/mL
Geometric Coefficient of Variation 31
|
20.4 μg*h/mL
Geometric Coefficient of Variation 22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC(0-tlast)) of LY3522348
Day 1
|
1.76 μg*h/mL
Geometric Coefficient of Variation 25
|
5.03 μg*h/mL
Geometric Coefficient of Variation 18
|
11.1 μg*h/mL
Geometric Coefficient of Variation 25
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144 hours post Day 1 dose)Population: All enrolled participants in Part A who received at least one dose of study drug and have evaluable PK data.
PK: Cmax of LY3522348
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
A single dose of Placebo administered orally on Day 1.
|
Part A: 5 mg LY3522348
n=6 Participants
A single dose of 5 mg LY3522348 administered orally on Day 1.
|
Part A: 15 mg LY3522348
n=6 Participants
A single dose of 15 mg LY3522348 administered orally on Day 1.
|
Part A: 50 mg LY3522348
n=6 Participants
A single dose of 50 mg LY3522348 administered orally on Day 1.
|
Part A: 150 mg LY3522348
n=6 Participants
A single dose of 150 mg LY3522348 administered orally on Day 1.
|
Part A: 380 mg LY3522348
A single dose of 380 mg LY3522348 administered orally on Day 1.
|
Part B: Placebo
Placebo administered orally once daily on Days 1-14.
|
Part B: Placebo + Midazolam
Placebo administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.
|
Part B: 50 mg LY3522348
50 mg LY3522348 administered orally once daily on Days 1-14.
|
Part B: 120 mg LY3522348
120 mg LY3522348 administered orally once daily on Days 1-14.
|
Part B: 290 mg LY3522348 + Midazolam
290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A PK: Maximum Observed Drug Concentration (Cmax) of LY3522348
|
0.00964 micrograms/mililiter (μg/mL)
Geometric Coefficient of Variation 17
|
0.0399 micrograms/mililiter (μg/mL)
Geometric Coefficient of Variation 23
|
0.113 micrograms/mililiter (μg/mL)
Geometric Coefficient of Variation 23
|
0.323 micrograms/mililiter (μg/mL)
Geometric Coefficient of Variation 39
|
0.897 micrograms/mililiter (μg/mL)
Geometric Coefficient of Variation 18
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24 hours post Day 1 dose); Day 14 (Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 144 hours post Day 14 dose)Population: All enrolled participants in Part B who received at least one dose of study drug and have evaluable PK data.
PK: Cmax of LY3522348
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
A single dose of Placebo administered orally on Day 1.
|
Part A: 5 mg LY3522348
n=6 Participants
A single dose of 5 mg LY3522348 administered orally on Day 1.
|
Part A: 15 mg LY3522348
n=6 Participants
A single dose of 15 mg LY3522348 administered orally on Day 1.
|
Part A: 50 mg LY3522348
A single dose of 50 mg LY3522348 administered orally on Day 1.
|
Part A: 150 mg LY3522348
A single dose of 150 mg LY3522348 administered orally on Day 1.
|
Part A: 380 mg LY3522348
A single dose of 380 mg LY3522348 administered orally on Day 1.
|
Part B: Placebo
Placebo administered orally once daily on Days 1-14.
|
Part B: Placebo + Midazolam
Placebo administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.
|
Part B: 50 mg LY3522348
50 mg LY3522348 administered orally once daily on Days 1-14.
|
Part B: 120 mg LY3522348
120 mg LY3522348 administered orally once daily on Days 1-14.
|
Part B: 290 mg LY3522348 + Midazolam
290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B PK: Maximum Observed Drug Concentration (Cmax) of LY3522348
Day 14
|
0.188 μg/mL
Geometric Coefficient of Variation 25
|
0.464 μg/mL
Geometric Coefficient of Variation 15
|
1.15 μg/mL
Geometric Coefficient of Variation 22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B PK: Maximum Observed Drug Concentration (Cmax) of LY3522348
Day 1
|
0.109 μg/mL
Geometric Coefficient of Variation 29
|
0.330 μg/mL
Geometric Coefficient of Variation 15
|
0.690 μg/mL
Geometric Coefficient of Variation 13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A: 5 mg LY3522348
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: 15 mg LY3522348
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A: 50 mg LY3522348
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A: 150 mg LY3522348
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: 380 mg LY3522348
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B: Placebo + Midazolam
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B: 50 mg LY3522348
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B: 120 mg LY3522348
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B: 290 mg LY3522348 + Midazolam
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: Placebo
n=10 participants at risk
A single dose of Placebo administered orally on Day 1.
|
Part A: 5 mg LY3522348
n=6 participants at risk
A single dose of 5 mg LY3522348 administered orally on Day 1.
|
Part A: 15 mg LY3522348
n=6 participants at risk
A single dose of 15 mg LY3522348 administered orally on Day 1.
|
Part A: 50 mg LY3522348
n=6 participants at risk
A single dose of 50 mg LY3522348 administered orally on Day 1.
|
Part A: 150 mg LY3522348
n=6 participants at risk
A single dose of 150 mg LY3522348 administered orally on Day 1.
|
Part A: 380 mg LY3522348
n=6 participants at risk
A single dose of 380 mg LY3522348 administered orally on Day 1.
|
Part B: Placebo
n=4 participants at risk
Placebo administered orally once daily on Days 1-14.
|
Part B: Placebo + Midazolam
n=2 participants at risk
Placebo administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.
|
Part B: 50 mg LY3522348
n=6 participants at risk
50 mg LY3522348 administered orally once daily on Days 1-14.
|
Part B: 120 mg LY3522348
n=6 participants at risk
120 mg LY3522348 administered orally once daily on Days 1-14.
|
Part B: 290 mg LY3522348 + Midazolam
n=7 participants at risk
290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/4 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/2 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
14.3%
1/7 • Number of events 1 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/4 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/2 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/7 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/4 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/2 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/7 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/10 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/4 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/2 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/7 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
|
General disorders
Medical device site dermatitis
|
0.00%
0/10 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
33.3%
2/6 • Number of events 2 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/4 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/2 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/7 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/10 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/4 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/2 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/7 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
|
Infections and infestations
COVID-19
|
10.0%
1/10 • Number of events 1 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/4 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/2 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/7 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/10 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/4 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/2 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/7 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/10 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/4 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/2 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/7 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
|
Eye disorders
Vision blurred
|
0.00%
0/10 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/4 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/2 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
16.7%
1/6 • Number of events 2 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/7 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/4 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/2 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
14.3%
1/7 • Number of events 1 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/10 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/4 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/2 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/7 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/4 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/2 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/7 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/4 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/2 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
33.3%
2/6 • Number of events 3 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/7 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/10 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
16.7%
1/6 • Number of events 1 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/4 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/2 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/6 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
0.00%
0/7 • Part A: Baseline up to Day 14; Part B: Baseline up to Day 28
All enrolled participants, irrespective of the completion of all protocol requirements.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60