Trial Outcomes & Findings for Phase 1 SAD/MAD Study of CVN766 in Healthy Volunteers (NCT NCT05105243)
NCT ID: NCT05105243
Last Updated: 2024-11-04
Results Overview
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as any AE with onset occurring within 30 days (onset date - last date of dose + 1 ≤30) after study drug administration. Percentage of participants reporting at least one TEAE has been presented.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
Up to Day 14
Results posted on
2024-11-04
Participant Flow
The study was conducted across 1 site in Australia.
This was a randomized, double-blind, placebo-controlled, safety, tolerability and pharmacokinetic study of escalating single ascending dose (SAD) and multiple ascending doses (MAD) of CVN766 in Healthy participants. Participants were randomized 6:1 (SAD) and 6:2 (MAD) to CVN766 or placebo.
Participant milestones
| Measure |
SAD CVN766 5 Milligrams (mg)
Participants were randomized to receive a single dose of 1 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 15 mg
Participants were randomized to receive a single dose of 15 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 45 mg
Participants were randomized to receive a single dose of 45 mg CVN766 oral suspension under overnight fasted and fed condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 125 mg
Participants were randomized to receive a single dose of 125 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 250 mg
Participants were randomized to receive a single dose of 250 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD Placebo
Participants were randomized to receive a single dose of matching placebo oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
MAD CVN766 45 mg
Participants were randomized to receive a daily dose of 45 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the Safety Review Group (SRG).
|
MAD CVN766 125 mg
Participants were randomized to receive a daily dose of 125 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD CVN766 250 mg
Participants were randomized to receive a daily dose of 250 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD Placebo
Participants were randomized to receive a daily dose of matching placebo oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
SAD Cohort 1: 5 mg (14 Days)
STARTED
|
6
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
SAD Cohort 1: 5 mg (14 Days)
COMPLETED
|
6
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
SAD Cohort 1: 5 mg (14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
SAD Cohort 2: 15 mg (14 Days)
STARTED
|
0
|
6
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
SAD Cohort 2: 15 mg (14 Days)
COMPLETED
|
0
|
6
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
SAD Cohort 2: 15 mg (14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
SAD Cohort 3: 45 mg (14 Days)
STARTED
|
0
|
0
|
6
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
SAD Cohort 3: 45 mg (14 Days)
COMPLETED
|
0
|
0
|
6
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
SAD Cohort 3: 45 mg (14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
SAD Cohort 4: 125 mg (14 Days)
STARTED
|
0
|
0
|
0
|
6
|
0
|
2
|
0
|
0
|
0
|
0
|
|
SAD Cohort 4: 125 mg (14 Days)
COMPLETED
|
0
|
0
|
0
|
6
|
0
|
2
|
0
|
0
|
0
|
0
|
|
SAD Cohort 4: 125 mg (14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
SAD Cohort 5: 250 mg (14 Days)
STARTED
|
0
|
0
|
0
|
0
|
6
|
2
|
0
|
0
|
0
|
0
|
|
SAD Cohort 5: 250 mg (14 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
6
|
2
|
0
|
0
|
0
|
0
|
|
SAD Cohort 5: 250 mg (14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
MAD Cohort 1: 45 mg (21 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
2
|
|
MAD Cohort 1: 45 mg (21 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
2
|
|
MAD Cohort 1: 45 mg (21 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
MAD Cohort 2: 125 mg (21 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
2
|
|
MAD Cohort 2: 125 mg (21 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
2
|
|
MAD Cohort 2: 125 mg (21 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
MAD Cohort 1: 250 mg (21 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
2
|
|
MAD Cohort 1: 250 mg (21 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
2
|
|
MAD Cohort 1: 250 mg (21 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1 SAD/MAD Study of CVN766 in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
SAD CVN766 5 mg
n=6 Participants
Participants were randomized to receive a single dose of 1 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 15 mg
n=6 Participants
Participants were randomized to receive a single dose of 15 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 45 mg
n=6 Participants
Participants were randomized to receive a single dose of 45 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 125 mg
n=6 Participants
Participants were randomized to receive a single dose of 125 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 250 mg
n=6 Participants
Participants were randomized to receive a single dose of 250 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD Placebo
n=10 Participants
Participants were randomized to receive a single dose of matching placebo oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
MAD CVN766 45 mg
n=6 Participants
Participants were randomized to receive a daily dose of 45 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the Safety Review Group (SRG).
|
MAD CVN766 125 mg
n=6 Participants
Participants were randomized to receive a daily dose of 125 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD CVN766 250 mg
n=6 Participants
Participants were randomized to receive a daily dose of 250 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD Placebo
n=6 Participants
Participants were randomized to receive a daily dose of matching placebo oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
29.5 Years
STANDARD_DEVIATION 5.3 • n=93 Participants
|
30.8 Years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
29.8 Years
STANDARD_DEVIATION 6.4 • n=27 Participants
|
26.8 Years
STANDARD_DEVIATION 6.5 • n=483 Participants
|
26.8 Years
STANDARD_DEVIATION 3.8 • n=36 Participants
|
31.9 Years
STANDARD_DEVIATION 13.3 • n=10 Participants
|
37.2 Years
STANDARD_DEVIATION 7.5 • n=115 Participants
|
27.5 Years
STANDARD_DEVIATION 7.6 • n=40 Participants
|
31.5 Years
STANDARD_DEVIATION 8.1 • n=8 Participants
|
26.8 Years
STANDARD_DEVIATION 4.8 • n=62 Participants
|
30.2 Years
STANDARD_DEVIATION 8.1 • n=95 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=62 Participants
|
19 Participants
n=95 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=62 Participants
|
45 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
6 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
10 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=62 Participants
|
55 Participants
n=95 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
3 Participants
n=95 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=62 Participants
|
41 Participants
n=95 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=62 Participants
|
19 Participants
n=95 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
|
Race/Ethnicity, Customized
Indigenous Australian or Torres Strait Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
|
Race/Ethnicity, Customized
Other, Mixed White Indigenous Australian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
PRIMARY outcome
Timeframe: Up to Day 14Population: Safety Population.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as any AE with onset occurring within 30 days (onset date - last date of dose + 1 ≤30) after study drug administration. Percentage of participants reporting at least one TEAE has been presented.
Outcome measures
| Measure |
SAD CVN766 5 mg
n=6 Participants
Participants were randomized to receive a single dose of 1 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 15 mg
n=6 Participants
Participants were randomized to receive a single dose of 15 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 45 mg
n=6 Participants
Participants were randomized to receive a single dose of 45 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 125 mg
n=6 Participants
Participants were randomized to receive a single dose of 125 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 250 mg
n=6 Participants
Participants were randomized to receive a single dose of 250 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD Placebo
n=10 Participants
Participants were randomized to receive a single dose of matching placebo oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
MAD CVN766 45 mg
n=6 Participants
Participants were randomized to receive a daily dose of 45 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the Safety Review Group (SRG).
|
MAD CVN766 125 mg
n=6 Participants
Participants were randomized to receive a daily dose of 125 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD CVN766 250 mg
n=6 Participants
Participants were randomized to receive a daily dose of 250 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD Placebo
n=6 Participants
Participants were randomized to receive a daily dose of matching placebo oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event (TEAE)
|
50.0 Percentage of participants
|
33.3 Percentage of participants
|
83.3 Percentage of participants
|
16.7 Percentage of participants
|
66.7 Percentage of participants
|
50.0 Percentage of participants
|
66.7 Percentage of participants
|
33.3 Percentage of participants
|
66.7 Percentage of participants
|
33.3 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Day 14Population: Safety Population.
Blood and urine samples were collected for the analysis of laboratory parameters including clinical chemistry, hematology, and urinalysis. The investigator was responsible for reviewing laboratory results for clinically significant abnormalities.
Outcome measures
| Measure |
SAD CVN766 5 mg
n=6 Participants
Participants were randomized to receive a single dose of 1 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 15 mg
n=6 Participants
Participants were randomized to receive a single dose of 15 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 45 mg
n=6 Participants
Participants were randomized to receive a single dose of 45 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 125 mg
n=6 Participants
Participants were randomized to receive a single dose of 125 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 250 mg
n=6 Participants
Participants were randomized to receive a single dose of 250 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD Placebo
n=10 Participants
Participants were randomized to receive a single dose of matching placebo oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
MAD CVN766 45 mg
n=6 Participants
Participants were randomized to receive a daily dose of 45 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the Safety Review Group (SRG).
|
MAD CVN766 125 mg
n=6 Participants
Participants were randomized to receive a daily dose of 125 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD CVN766 250 mg
n=6 Participants
Participants were randomized to receive a daily dose of 250 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD Placebo
n=6 Participants
Participants were randomized to receive a daily dose of matching placebo oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Clinically Significant Abnormal Laboratory Parameters
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Day 14Population: Safety Population.
12-lead ECG recordings including heart rate and measured PR, QRS, QT, QT interval with Fridericia's correction method (QTcF) and QT interval with Bazett's correction method (QTcB) intervals. 12-lead ECG recordings were obtained after the participants have rested for at least 5 minutes in supine position. The investigator was responsible for reviewing laboratory results for clinically significant abnormalities.
Outcome measures
| Measure |
SAD CVN766 5 mg
n=6 Participants
Participants were randomized to receive a single dose of 1 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 15 mg
n=6 Participants
Participants were randomized to receive a single dose of 15 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 45 mg
n=6 Participants
Participants were randomized to receive a single dose of 45 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 125 mg
n=6 Participants
Participants were randomized to receive a single dose of 125 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 250 mg
n=6 Participants
Participants were randomized to receive a single dose of 250 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD Placebo
n=10 Participants
Participants were randomized to receive a single dose of matching placebo oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
MAD CVN766 45 mg
n=6 Participants
Participants were randomized to receive a daily dose of 45 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the Safety Review Group (SRG).
|
MAD CVN766 125 mg
n=6 Participants
Participants were randomized to receive a daily dose of 125 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD CVN766 250 mg
n=6 Participants
Participants were randomized to receive a daily dose of 250 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD Placebo
n=6 Participants
Participants were randomized to receive a daily dose of matching placebo oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Findings
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Day 14Population: Safety Population.
Vital signs including blood pressure (systolic and diastolic blood pressure), pulse rate, body temperature, respiratory rate and weight were measured after the participants have rested for at least 5 minutes in supine position. The investigator was responsible for reviewing laboratory results for clinically significant abnormalities.
Outcome measures
| Measure |
SAD CVN766 5 mg
n=6 Participants
Participants were randomized to receive a single dose of 1 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 15 mg
n=6 Participants
Participants were randomized to receive a single dose of 15 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 45 mg
n=6 Participants
Participants were randomized to receive a single dose of 45 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 125 mg
n=6 Participants
Participants were randomized to receive a single dose of 125 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 250 mg
n=6 Participants
Participants were randomized to receive a single dose of 250 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD Placebo
n=10 Participants
Participants were randomized to receive a single dose of matching placebo oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
MAD CVN766 45 mg
n=6 Participants
Participants were randomized to receive a daily dose of 45 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the Safety Review Group (SRG).
|
MAD CVN766 125 mg
n=6 Participants
Participants were randomized to receive a daily dose of 125 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD CVN766 250 mg
n=6 Participants
Participants were randomized to receive a daily dose of 250 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD Placebo
n=6 Participants
Participants were randomized to receive a daily dose of matching placebo oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Clinically Significant Abnormal Vital Signs
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48, and 72 hours postdose at Day 1Population: PK Population: included all participants who received study drug and had at least 1 measurable plasma concentration.
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of CVN766. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
SAD CVN766 5 mg
n=6 Participants
Participants were randomized to receive a single dose of 1 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 15 mg
n=6 Participants
Participants were randomized to receive a single dose of 15 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 45 mg
n=6 Participants
Participants were randomized to receive a single dose of 45 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 125 mg
n=6 Participants
Participants were randomized to receive a single dose of 125 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 250 mg
n=6 Participants
Participants were randomized to receive a single dose of 250 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD Placebo
Participants were randomized to receive a single dose of matching placebo oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
MAD CVN766 45 mg
Participants were randomized to receive a daily dose of 45 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the Safety Review Group (SRG).
|
MAD CVN766 125 mg
Participants were randomized to receive a daily dose of 125 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD CVN766 250 mg
Participants were randomized to receive a daily dose of 250 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD Placebo
Participants were randomized to receive a daily dose of matching placebo oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Cmax) (Tmax) After Single Dose Administration of CVN766
|
0.9165 hours
Interval 0.5 to 1.1
|
1.0000 hours
Interval 0.5 to 1.5
|
1.0000 hours
Interval 0.5 to 1.5
|
1.5000 hours
Interval 1.05 to 2.0
|
1.5000 hours
Interval 1.033 to 3.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16 and 24 hours postdose at Day 1Population: PK Population.
Blood samples were collected at indicated time points for PK analysis of CVN766. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
SAD CVN766 5 mg
n=6 Participants
Participants were randomized to receive a single dose of 1 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 15 mg
n=6 Participants
Participants were randomized to receive a single dose of 15 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 45 mg
n=6 Participants
Participants were randomized to receive a single dose of 45 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 125 mg
n=6 Participants
Participants were randomized to receive a single dose of 125 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 250 mg
n=6 Participants
Participants were randomized to receive a single dose of 250 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD Placebo
Participants were randomized to receive a single dose of matching placebo oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
MAD CVN766 45 mg
Participants were randomized to receive a daily dose of 45 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the Safety Review Group (SRG).
|
MAD CVN766 125 mg
Participants were randomized to receive a daily dose of 125 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD CVN766 250 mg
Participants were randomized to receive a daily dose of 250 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD Placebo
Participants were randomized to receive a daily dose of matching placebo oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to 24 (AUC24) After Single Dose Administration of CVN766
|
319.904 Hours*nanograms per milliliter
Geometric Coefficient of Variation 25.0
|
2155.879 Hours*nanograms per milliliter
Geometric Coefficient of Variation 31.6
|
4001.523 Hours*nanograms per milliliter
Geometric Coefficient of Variation 37.0
|
10990.192 Hours*nanograms per milliliter
Geometric Coefficient of Variation 72.1
|
15607.247 Hours*nanograms per milliliter
Geometric Coefficient of Variation 36.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48, and 72 hours postdose at Day 1Population: PK Population.
Blood samples were collected at indicated time points for PK analysis of CVN766. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
SAD CVN766 5 mg
n=6 Participants
Participants were randomized to receive a single dose of 1 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 15 mg
n=6 Participants
Participants were randomized to receive a single dose of 15 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 45 mg
n=6 Participants
Participants were randomized to receive a single dose of 45 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 125 mg
n=6 Participants
Participants were randomized to receive a single dose of 125 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 250 mg
n=6 Participants
Participants were randomized to receive a single dose of 250 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD Placebo
Participants were randomized to receive a single dose of matching placebo oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
MAD CVN766 45 mg
Participants were randomized to receive a daily dose of 45 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the Safety Review Group (SRG).
|
MAD CVN766 125 mg
Participants were randomized to receive a daily dose of 125 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD CVN766 250 mg
Participants were randomized to receive a daily dose of 250 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD Placebo
Participants were randomized to receive a daily dose of matching placebo oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC [0-infinity]) After Single Dose Administration of CVN766
|
322.066 Hours*nanograms per milliliter
Geometric Coefficient of Variation 25.7
|
2414.049 Hours*nanograms per milliliter
Geometric Coefficient of Variation 43.4
|
4260.722 Hours*nanograms per milliliter
Geometric Coefficient of Variation 37.2
|
13527.110 Hours*nanograms per milliliter
Geometric Coefficient of Variation 98.9
|
19573.857 Hours*nanograms per milliliter
Geometric Coefficient of Variation 39.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48, and 72 hours postdose at Day 1Population: PK Population.
Blood samples were collected at indicated time points for PK analysis of CVN766. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
SAD CVN766 5 mg
n=6 Participants
Participants were randomized to receive a single dose of 1 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 15 mg
n=6 Participants
Participants were randomized to receive a single dose of 15 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 45 mg
n=6 Participants
Participants were randomized to receive a single dose of 45 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 125 mg
n=6 Participants
Participants were randomized to receive a single dose of 125 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 250 mg
n=6 Participants
Participants were randomized to receive a single dose of 250 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD Placebo
Participants were randomized to receive a single dose of matching placebo oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
MAD CVN766 45 mg
Participants were randomized to receive a daily dose of 45 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the Safety Review Group (SRG).
|
MAD CVN766 125 mg
Participants were randomized to receive a daily dose of 125 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD CVN766 250 mg
Participants were randomized to receive a daily dose of 250 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD Placebo
Participants were randomized to receive a daily dose of matching placebo oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-life (t1/2z) After Single Dose Administration of CVN766
|
2.9625 hours
Standard Deviation 0.92895
|
7.3485 hours
Standard Deviation 4.57313
|
5.7745 hours
Standard Deviation 2.11356
|
11.4565 hours
Standard Deviation 10.57028
|
8.6156 hours
Standard Deviation 1.75924
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 1, 2, 3, 4, 5 and 6Population: PK Population. Only those participants with data available at specified time points have been presented.
Blood samples were collected at indicated time points for PK analysis of CVN766. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
SAD CVN766 5 mg
n=5 Participants
Participants were randomized to receive a single dose of 1 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 15 mg
n=6 Participants
Participants were randomized to receive a single dose of 15 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 45 mg
n=6 Participants
Participants were randomized to receive a single dose of 45 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 125 mg
Participants were randomized to receive a single dose of 125 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 250 mg
Participants were randomized to receive a single dose of 250 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD Placebo
Participants were randomized to receive a single dose of matching placebo oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
MAD CVN766 45 mg
Participants were randomized to receive a daily dose of 45 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the Safety Review Group (SRG).
|
MAD CVN766 125 mg
Participants were randomized to receive a daily dose of 125 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD CVN766 250 mg
Participants were randomized to receive a daily dose of 250 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD Placebo
Participants were randomized to receive a daily dose of matching placebo oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Trough Concentrations After Repeat Dose Administration of CVN766
Day 1
|
32.443 Nanograms per milliliter
Geometric Coefficient of Variation 94.0
|
208.061 Nanograms per milliliter
Geometric Coefficient of Variation 60.4
|
605.924 Nanograms per milliliter
Geometric Coefficient of Variation 68.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Trough Concentrations After Repeat Dose Administration of CVN766
Day 2
|
47.839 Nanograms per milliliter
Geometric Coefficient of Variation 90.2
|
278.564 Nanograms per milliliter
Geometric Coefficient of Variation 75.0
|
856.904 Nanograms per milliliter
Geometric Coefficient of Variation 75.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Trough Concentrations After Repeat Dose Administration of CVN766
Day 3
|
65.131 Nanograms per milliliter
Geometric Coefficient of Variation 65.0
|
298.945 Nanograms per milliliter
Geometric Coefficient of Variation 74.2
|
1002.607 Nanograms per milliliter
Geometric Coefficient of Variation 98.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Trough Concentrations After Repeat Dose Administration of CVN766
Day 4
|
61.883 Nanograms per milliliter
Geometric Coefficient of Variation 59.3
|
325.191 Nanograms per milliliter
Geometric Coefficient of Variation 76.0
|
1058.768 Nanograms per milliliter
Geometric Coefficient of Variation 108.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Trough Concentrations After Repeat Dose Administration of CVN766
Day 5
|
75.024 Nanograms per milliliter
Geometric Coefficient of Variation 55.5
|
330.735 Nanograms per milliliter
Geometric Coefficient of Variation 85.3
|
1075.797 Nanograms per milliliter
Geometric Coefficient of Variation 96.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Trough Concentrations After Repeat Dose Administration of CVN766
Day 6
|
81.352 Nanograms per milliliter
Geometric Coefficient of Variation 76.5
|
359.249 Nanograms per milliliter
Geometric Coefficient of Variation 83.3
|
1068.025 Nanograms per milliliter
Geometric Coefficient of Variation 82.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, and 24 (Day 2 predose) hours postdose at Day 1Population: PK Population.
Blood samples were collected at indicated time points for PK analysis of CVN766. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
SAD CVN766 5 mg
n=6 Participants
Participants were randomized to receive a single dose of 1 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 15 mg
n=6 Participants
Participants were randomized to receive a single dose of 15 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 45 mg
n=6 Participants
Participants were randomized to receive a single dose of 45 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 125 mg
Participants were randomized to receive a single dose of 125 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 250 mg
Participants were randomized to receive a single dose of 250 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD Placebo
Participants were randomized to receive a single dose of matching placebo oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
MAD CVN766 45 mg
Participants were randomized to receive a daily dose of 45 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the Safety Review Group (SRG).
|
MAD CVN766 125 mg
Participants were randomized to receive a daily dose of 125 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD CVN766 250 mg
Participants were randomized to receive a daily dose of 250 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD Placebo
Participants were randomized to receive a daily dose of matching placebo oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax After Repeat Dose Administration of CVN766
|
534.420 Nanograms per milliliter
Geometric Coefficient of Variation 19.8
|
1309.959 Nanograms per milliliter
Geometric Coefficient of Variation 30.6
|
2398.089 Nanograms per milliliter
Geometric Coefficient of Variation 38.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48, and 72 a hours postdose at Day 7Population: PK Population.
Blood samples were collected at indicated time points for PK analysis of CVN766. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
SAD CVN766 5 mg
n=6 Participants
Participants were randomized to receive a single dose of 1 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 15 mg
n=6 Participants
Participants were randomized to receive a single dose of 15 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 45 mg
n=6 Participants
Participants were randomized to receive a single dose of 45 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 125 mg
Participants were randomized to receive a single dose of 125 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 250 mg
Participants were randomized to receive a single dose of 250 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD Placebo
Participants were randomized to receive a single dose of matching placebo oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
MAD CVN766 45 mg
Participants were randomized to receive a daily dose of 45 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the Safety Review Group (SRG).
|
MAD CVN766 125 mg
Participants were randomized to receive a daily dose of 125 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD CVN766 250 mg
Participants were randomized to receive a daily dose of 250 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD Placebo
Participants were randomized to receive a daily dose of matching placebo oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
AUC From Time 0 to the End of Dosing Interval (AUCtau) After Repeat Dose Administration of CVN766
|
5523.759 Hours*nanograms per milliliter
Geometric Coefficient of Variation 39.3
|
18712.219 Hours*nanograms per milliliter
Geometric Coefficient of Variation 45.8
|
42303.478 Hours*nanograms per milliliter
Geometric Coefficient of Variation 49.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48, and 72 a hours postdose at Day 7Population: PK Population.
Blood samples were collected at indicated time points for PK analysis of CVN766. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
SAD CVN766 5 mg
n=6 Participants
Participants were randomized to receive a single dose of 1 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 15 mg
n=6 Participants
Participants were randomized to receive a single dose of 15 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 45 mg
n=6 Participants
Participants were randomized to receive a single dose of 45 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 125 mg
Participants were randomized to receive a single dose of 125 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 250 mg
Participants were randomized to receive a single dose of 250 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD Placebo
Participants were randomized to receive a single dose of matching placebo oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
MAD CVN766 45 mg
Participants were randomized to receive a daily dose of 45 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the Safety Review Group (SRG).
|
MAD CVN766 125 mg
Participants were randomized to receive a daily dose of 125 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD CVN766 250 mg
Participants were randomized to receive a daily dose of 250 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD Placebo
Participants were randomized to receive a daily dose of matching placebo oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
T1/2z After Repeat Dose Administration of CVN766
|
7.7710 hours
Standard Deviation 3.20745
|
10.9721 hours
Standard Deviation 6.76714
|
12.1702 hours
Standard Deviation 4.47362
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48, and 72 a hours postdose at Day 7Population: PK Population.
Blood samples were collected at indicated time points for PK analysis of CVN766. PK parameters were analyzed using standard non-compartmental analysis. Rac (Cmax) was calculated as steady state Cmax at Day 7 divided by Cmax Day 1.
Outcome measures
| Measure |
SAD CVN766 5 mg
n=6 Participants
Participants were randomized to receive a single dose of 1 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 15 mg
n=6 Participants
Participants were randomized to receive a single dose of 15 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 45 mg
n=6 Participants
Participants were randomized to receive a single dose of 45 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 125 mg
Participants were randomized to receive a single dose of 125 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 250 mg
Participants were randomized to receive a single dose of 250 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD Placebo
Participants were randomized to receive a single dose of matching placebo oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
MAD CVN766 45 mg
Participants were randomized to receive a daily dose of 45 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the Safety Review Group (SRG).
|
MAD CVN766 125 mg
Participants were randomized to receive a daily dose of 125 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD CVN766 250 mg
Participants were randomized to receive a daily dose of 250 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD Placebo
Participants were randomized to receive a daily dose of matching placebo oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio (Rac) of Cmax After Repeat Dose Administration of CVN766
|
1.390 Ratio
Geometric Coefficient of Variation 13.7
|
1.528 Ratio
Geometric Coefficient of Variation 41.7
|
1.588 Ratio
Geometric Coefficient of Variation 33.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48, and 72 a hours postdose at Day 7Population: PK Population.
Blood samples were collected at indicated time points for PK analysis of CVN766. PK parameters were analyzed using standard non-compartmental analysis. Rac (AUC) was calculated as steady state AUC at Day 7 divided by AUC Day 1
Outcome measures
| Measure |
SAD CVN766 5 mg
n=6 Participants
Participants were randomized to receive a single dose of 1 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 15 mg
n=6 Participants
Participants were randomized to receive a single dose of 15 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 45 mg
n=6 Participants
Participants were randomized to receive a single dose of 45 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 125 mg
Participants were randomized to receive a single dose of 125 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 250 mg
Participants were randomized to receive a single dose of 250 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD Placebo
Participants were randomized to receive a single dose of matching placebo oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
MAD CVN766 45 mg
Participants were randomized to receive a daily dose of 45 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the Safety Review Group (SRG).
|
MAD CVN766 125 mg
Participants were randomized to receive a daily dose of 125 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD CVN766 250 mg
Participants were randomized to receive a daily dose of 250 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD Placebo
Participants were randomized to receive a daily dose of matching placebo oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Rac of AUC After Repeat Dose Administration of CVN766
|
1.627 Ratio
Geometric Coefficient of Variation 25.6
|
1.517 Ratio
Geometric Coefficient of Variation 49.3
|
1.771 Ratio
Geometric Coefficient of Variation 28.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48, and 72 a hours postdose at Day 7Population: PK Population. Only those participants with data available at specified time points have been presented.
Blood samples were collected at indicated time points for PK analysis of time to reach steady state of CVN766. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
SAD CVN766 5 mg
n=6 Participants
Participants were randomized to receive a single dose of 1 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 15 mg
n=6 Participants
Participants were randomized to receive a single dose of 15 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 45 mg
n=6 Participants
Participants were randomized to receive a single dose of 45 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 125 mg
Participants were randomized to receive a single dose of 125 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 250 mg
Participants were randomized to receive a single dose of 250 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD Placebo
Participants were randomized to receive a single dose of matching placebo oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
MAD CVN766 45 mg
Participants were randomized to receive a daily dose of 45 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the Safety Review Group (SRG).
|
MAD CVN766 125 mg
Participants were randomized to receive a daily dose of 125 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD CVN766 250 mg
Participants were randomized to receive a daily dose of 250 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD Placebo
Participants were randomized to receive a daily dose of matching placebo oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Steady State of CVN766 Concentration in the Dosing Interval
Tmax, ss
|
1.2750 hours
Interval 0.5 to 2.017
|
2.0000 hours
Interval 1.5 to 2.0
|
1.7415 hours
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach Steady State of CVN766 Concentration in the Dosing Interval
Tmin, ss
|
24.0000 hours
Interval 24.0 to 24.0
|
24.0000 hours
Interval 16.0 to 24.0
|
20.0165 hours
Interval 16.033 to 24.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach Steady State of CVN766 Concentration in the Dosing Interval
Tlast, ss
|
42.0000 hours
Interval 16.1 to 48.083
|
48.0335 hours
Interval 48.0 to 73.967
|
73.2915 hours
Interval 48.0 to 77.767
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48, and 72 a hours postdose at Day 7Population: PK Population
Blood samples were collected at indicated time points for PK analysis of CVN766. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
SAD CVN766 5 mg
n=6 Participants
Participants were randomized to receive a single dose of 1 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 15 mg
n=6 Participants
Participants were randomized to receive a single dose of 15 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 45 mg
n=6 Participants
Participants were randomized to receive a single dose of 45 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 125 mg
Participants were randomized to receive a single dose of 125 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 250 mg
Participants were randomized to receive a single dose of 250 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD Placebo
Participants were randomized to receive a single dose of matching placebo oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
MAD CVN766 45 mg
Participants were randomized to receive a daily dose of 45 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the Safety Review Group (SRG).
|
MAD CVN766 125 mg
Participants were randomized to receive a daily dose of 125 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD CVN766 250 mg
Participants were randomized to receive a daily dose of 250 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD Placebo
Participants were randomized to receive a daily dose of matching placebo oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Steady State Cmax After Repeat Dose Administration of CVN766
|
742.582 Nanograms per milliliter
Geometric Coefficient of Variation 14.8
|
2001.021 Nanograms per milliliter
Geometric Coefficient of Variation 32.9
|
3807.481 Nanograms per milliliter
Geometric Coefficient of Variation 33.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36, 48, and 72 a hours postdose at Day 7Population: PK Population. Only those participants with data available at specified time points have been presented.
Blood samples were collected at indicated time points for PK analysis of CVN766. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
SAD CVN766 5 mg
n=5 Participants
Participants were randomized to receive a single dose of 1 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 15 mg
n=6 Participants
Participants were randomized to receive a single dose of 15 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 45 mg
n=6 Participants
Participants were randomized to receive a single dose of 45 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 125 mg
Participants were randomized to receive a single dose of 125 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 250 mg
Participants were randomized to receive a single dose of 250 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD Placebo
Participants were randomized to receive a single dose of matching placebo oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
MAD CVN766 45 mg
Participants were randomized to receive a daily dose of 45 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the Safety Review Group (SRG).
|
MAD CVN766 125 mg
Participants were randomized to receive a daily dose of 125 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD CVN766 250 mg
Participants were randomized to receive a daily dose of 250 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD Placebo
Participants were randomized to receive a daily dose of matching placebo oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Steady State Minimum Observed Plasma Concentration (Cmin) After Repeat Dose Administration of CVN766
|
77.760 Nanograms per milliliter
Geometric Coefficient of Variation 74.5
|
315.991 Nanograms per milliliter
Geometric Coefficient of Variation 89.7
|
1042.811 Nanograms per milliliter
Geometric Coefficient of Variation 79.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 3 hours post-dosePopulation: PK Population.
The CSF samples were collected at indicated time point for PK analysis of CVN766. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
SAD CVN766 5 mg
n=6 Participants
Participants were randomized to receive a single dose of 1 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 15 mg
Participants were randomized to receive a single dose of 15 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 45 mg
Participants were randomized to receive a single dose of 45 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 125 mg
Participants were randomized to receive a single dose of 125 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 250 mg
Participants were randomized to receive a single dose of 250 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD Placebo
Participants were randomized to receive a single dose of matching placebo oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
MAD CVN766 45 mg
Participants were randomized to receive a daily dose of 45 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the Safety Review Group (SRG).
|
MAD CVN766 125 mg
Participants were randomized to receive a daily dose of 125 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD CVN766 250 mg
Participants were randomized to receive a daily dose of 250 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD Placebo
Participants were randomized to receive a daily dose of matching placebo oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Ratio of the CVN766 Concentration in Cerebrospinal Fluid (CSF) Versus the Plasma Concentration After Single Ascending Dose of CVN766 45 mg
|
11.558 Unitless
Geometric Coefficient of Variation 31.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 3 hours post-dosePopulation: PK Population.
The CSF samples were collected at indicated time point for PK analysis of CVN766. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
SAD CVN766 5 mg
n=6 Participants
Participants were randomized to receive a single dose of 1 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 15 mg
Participants were randomized to receive a single dose of 15 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 45 mg
Participants were randomized to receive a single dose of 45 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 125 mg
Participants were randomized to receive a single dose of 125 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 250 mg
Participants were randomized to receive a single dose of 250 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD Placebo
Participants were randomized to receive a single dose of matching placebo oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
MAD CVN766 45 mg
Participants were randomized to receive a daily dose of 45 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the Safety Review Group (SRG).
|
MAD CVN766 125 mg
Participants were randomized to receive a daily dose of 125 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD CVN766 250 mg
Participants were randomized to receive a daily dose of 250 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD Placebo
Participants were randomized to receive a daily dose of matching placebo oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Ratio of the CVN766 Concentration in CSF vs the Plasma Concentration After Repeated Dose Administration of CVN766
|
13.083 Unitless
Geometric Coefficient of Variation 25.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
SAD CVN766 5 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SAD CVN766 15 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SAD CVN766 45 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
SAD CVN766 125 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SAD CVN766 250 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
SAD Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
MAD CVN766 45 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MAD CVN766 125 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MAD CVN766 250 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MAD Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SAD CVN766 5 mg
n=6 participants at risk
Participants were randomized to receive a single dose of 1 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 15 mg
n=6 participants at risk
Participants were randomized to receive a single dose of 15 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 45 mg
n=6 participants at risk
Participants were randomized to receive a single dose of 45 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 125 mg
n=6 participants at risk
Participants were randomized to receive a single dose of 125 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD CVN766 250 mg
n=6 participants at risk
Participants were randomized to receive a single dose of 250 mg CVN766 oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
SAD Placebo
n=10 participants at risk
Participants were randomized to receive a single dose of matching placebo oral suspension under overnight fasted condition. Participants remained fasted for 4 hours post dose.
|
MAD CVN766 45 mg
n=6 participants at risk
Participants were randomized to receive a daily dose of 45 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the Safety Review Group (SRG).
|
MAD CVN766 125 mg
n=6 participants at risk
Participants were randomized to receive a daily dose of 125 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD CVN766 250 mg
n=6 participants at risk
Participants were randomized to receive a daily dose of 250 mg CVN766 oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
MAD Placebo
n=6 participants at risk
Participants were randomized to receive a daily dose of matching placebo oral suspension in fasting or fed state for 7 days, which was determined by the SRG.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Presyncope
|
33.3%
2/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
33.3%
2/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
33.3%
2/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Nervous system disorders
Dizziness postural
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
10.0%
1/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
20.0%
2/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
33.3%
2/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
10.0%
1/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
10.0%
1/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Injury, poisoning and procedural complications
Vascular access site inflammation
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Injury, poisoning and procedural complications
Vascular access site bruising
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
10.0%
1/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
10.0%
1/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
10.0%
1/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
33.3%
2/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
10.0%
1/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
General disorders
Suprapubic pain
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
20.0%
2/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
10.0%
1/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Investigations
Transaminases increased
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
|
Psychiatric disorders
Sleep talking
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/10 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
16.7%
1/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
0.00%
0/6 • Day 1 through Day 14
Safety Analysis Population: included all participants who were enrolled and received study drug.
|
Additional Information
Michelle Charles, Executive Director Regulatory Affairs
Cerevance
Phone: (408) 220-5722
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place