Trial Outcomes & Findings for Relative Bioavailability and Food Effect Study of CVN424 (NCT NCT05635461)
NCT ID: NCT05635461
Last Updated: 2024-09-19
Results Overview
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose
Results posted on
2024-09-19
Participant Flow
This was an Open-label, single oral dose, 3-way cross-over trial that evaluated the relative bioavailability of CVN424 suspension and tablet formulations and also included the assessment of the effect of food on the tablet formulation in healthy adult volunteers.
A total of 32 participants entered the study and were randomized per protocol to 6 treatment sequences.
Participant milestones
| Measure |
Treatment Sequence ABC
Participants were randomized to receive single oral dose of CVN424 150 milligrams (mg) on Day 1 of each treatment period in the following sequence: Treatment A: CVN424 150 mg suspension (fasted) in period 1; Treatment B: CVN424 150 mg Tablet (fasted) in period 2 and Treatment C: CVN424 150 mg Tablet (fed) in Treatment period 3. There was a washout period of 14 days between each treatment period.
|
Treatment Sequence ACB
Participants were randomized to receive single oral dose of CVN424 150 mg on Day 1 of each treatment period in the following sequence: Treatment A: CVN424 150 mg suspension (fasted) in period 1; Treatment C: CVN424 150 mg Tablet (fed) in Treatment period 2 and Treatment B: CVN424 150 mg Tablet (fasted) in period 3. There was a washout period of 14 days between each treatment period.
|
Treatment Sequence BAC
Participants were randomized to receive single oral dose of CVN424 150 mg on Day 1 of each treatment period in the following sequence: Treatment B: CVN424 150 mg Tablet (fasted) in period 1; Treatment A: CVN424 150 mg suspension (fasted) in Treatment period 2 and Treatment C: CVN424 150 mg Tablet (fed) in period 3. There was a washout period of 14 days between each treatment period.
|
Treatment Sequence BCA
Participants were randomized to receive single oral dose of CVN424 150 milligrams (mg) on Day 1 of each treatment period in the following sequence: Treatment B: CVN424 150 mg Tablet (fasted) in period 1; Treatment C: CVN424 150 mg Tablet (fed) in period 2 and Treatment A: CVN424 150 mg suspension (fasted) in Treatment period 3. There was a washout period of 14 days between each treatment period.
|
Treatment Sequence CAB
Participants were randomized to receive single oral dose of CVN424 150 mg on Day 1 of each treatment period in the following sequence: Treatment C: CVN424 150 mg Tablet (fed) in Treatment period 1; Treatment A: CVN424 150 mg suspension (fasted) in period 2 and Treatment B: CVN424 150 mg Tablet (fasted) in period 3. There was a washout period of 14 days between each treatment period.
|
Treatment Sequence CBA
Participants were randomized to receive single oral dose of CVN424 150 mg on Day 1 of each treatment period in the following sequence: Treatment C: CVN424 150 mg Tablet (fed) in Treatment period 1; Treatment B: CVN424 150 mg Tablet (fasted) in period 2 and Treatment A: CVN424 150 mg suspension (fasted) in period 3. There was a washout period of 14 days between each treatment period.
|
|---|---|---|---|---|---|---|
|
Period 1: Dosing 1 (Day 1)
STARTED
|
5
|
5
|
5
|
6
|
5
|
6
|
|
Period 1: Dosing 1 (Day 1)
COMPLETED
|
5
|
5
|
5
|
6
|
5
|
6
|
|
Period 1: Dosing 1 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period (7 Days)
STARTED
|
5
|
5
|
5
|
6
|
4
|
6
|
|
Washout Period (7 Days)
COMPLETED
|
5
|
5
|
5
|
6
|
4
|
6
|
|
Washout Period (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2: Dosing 2 (Day 1)
STARTED
|
5
|
5
|
5
|
6
|
5
|
6
|
|
Period 2: Dosing 2 (Day 1)
COMPLETED
|
5
|
5
|
5
|
6
|
4
|
6
|
|
Period 2: Dosing 2 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 3: Dosing 3 (Day 1)
STARTED
|
5
|
5
|
5
|
6
|
4
|
6
|
|
Period 3: Dosing 3 (Day 1)
COMPLETED
|
5
|
4
|
5
|
5
|
4
|
6
|
|
Period 3: Dosing 3 (Day 1)
NOT COMPLETED
|
0
|
1
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence ABC
Participants were randomized to receive single oral dose of CVN424 150 milligrams (mg) on Day 1 of each treatment period in the following sequence: Treatment A: CVN424 150 mg suspension (fasted) in period 1; Treatment B: CVN424 150 mg Tablet (fasted) in period 2 and Treatment C: CVN424 150 mg Tablet (fed) in Treatment period 3. There was a washout period of 14 days between each treatment period.
|
Treatment Sequence ACB
Participants were randomized to receive single oral dose of CVN424 150 mg on Day 1 of each treatment period in the following sequence: Treatment A: CVN424 150 mg suspension (fasted) in period 1; Treatment C: CVN424 150 mg Tablet (fed) in Treatment period 2 and Treatment B: CVN424 150 mg Tablet (fasted) in period 3. There was a washout period of 14 days between each treatment period.
|
Treatment Sequence BAC
Participants were randomized to receive single oral dose of CVN424 150 mg on Day 1 of each treatment period in the following sequence: Treatment B: CVN424 150 mg Tablet (fasted) in period 1; Treatment A: CVN424 150 mg suspension (fasted) in Treatment period 2 and Treatment C: CVN424 150 mg Tablet (fed) in period 3. There was a washout period of 14 days between each treatment period.
|
Treatment Sequence BCA
Participants were randomized to receive single oral dose of CVN424 150 milligrams (mg) on Day 1 of each treatment period in the following sequence: Treatment B: CVN424 150 mg Tablet (fasted) in period 1; Treatment C: CVN424 150 mg Tablet (fed) in period 2 and Treatment A: CVN424 150 mg suspension (fasted) in Treatment period 3. There was a washout period of 14 days between each treatment period.
|
Treatment Sequence CAB
Participants were randomized to receive single oral dose of CVN424 150 mg on Day 1 of each treatment period in the following sequence: Treatment C: CVN424 150 mg Tablet (fed) in Treatment period 1; Treatment A: CVN424 150 mg suspension (fasted) in period 2 and Treatment B: CVN424 150 mg Tablet (fasted) in period 3. There was a washout period of 14 days between each treatment period.
|
Treatment Sequence CBA
Participants were randomized to receive single oral dose of CVN424 150 mg on Day 1 of each treatment period in the following sequence: Treatment C: CVN424 150 mg Tablet (fed) in Treatment period 1; Treatment B: CVN424 150 mg Tablet (fasted) in period 2 and Treatment A: CVN424 150 mg suspension (fasted) in period 3. There was a washout period of 14 days between each treatment period.
|
|---|---|---|---|---|---|---|
|
Period 2: Dosing 2 (Day 1)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 3: Dosing 3 (Day 1)
Failed Check-In Laboratory
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Period 3: Dosing 3 (Day 1)
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Relative Bioavailability and Food Effect Study of CVN424
Baseline characteristics by cohort
| Measure |
Treatment Sequence ABC
n=5 Participants
Participants were randomized to receive single oral dose of CVN424 150 milligrams (mg) on Day 1 of each treatment period in the following sequence: Treatment A: CVN424 150 mg suspension (fasted) in period 1; Treatment B: CVN424 150 mg Tablet (fasted) in period 2 and Treatment C: CVN424 150 mg Tablet (fed) in Treatment period 3. There was a washout period of 14 days between each treatment period.
|
Treatment Sequence ACB
n=5 Participants
Participants were randomized to receive single oral dose of CVN424 150 mg on Day 1 of each treatment period in the following sequence: Treatment A: CVN424 150 mg suspension (fasted) in period 1; Treatment C: CVN424 150 mg Tablet (fed) in Treatment period 2 and Treatment B: CVN424 150 mg Tablet (fasted) in period 3. There was a washout period of 14 days between each treatment period.
|
Treatment Sequence BAC
n=5 Participants
Participants were randomized to receive single oral dose of CVN424 150 mg on Day 1 of each treatment period in the following sequence: Treatment B: CVN424 150 mg Tablet (fasted) in period 1; Treatment A: CVN424 150 mg suspension (fasted) in Treatment period 2 and Treatment C: CVN424 150 mg Tablet (fed) in period 3. There was a washout period of 14 days between each treatment period.
|
Treatment Sequence BCA
n=6 Participants
Participants were randomized to receive single oral dose of CVN424 150 milligrams (mg) on Day 1 of each treatment period in the following sequence: Treatment B: CVN424 150 mg Tablet (fasted) in period 1; Treatment C: CVN424 150 mg Tablet (fed) in period 2 and Treatment A: CVN424 150 mg suspension (fasted) in Treatment period 3. There was a washout period of 14 days between each treatment period.
|
Treatment Sequence CAB
n=5 Participants
Participants were randomized to receive single oral dose of CVN424 150 mg on Day 1 of each treatment period in the following sequence: Treatment C: CVN424 150 mg Tablet (fed) in Treatment period 1; Treatment A: CVN424 150 mg suspension (fasted) in period 2 and Treatment B: CVN424 150 mg Tablet (fasted) in period 3. There was a washout period of 14 days between each treatment period.
|
Treatment Sequence CBA
n=6 Participants
Participants were randomized to receive single oral dose of CVN424 150 mg on Day 1 of each treatment period in the following sequence: Treatment C: CVN424 150 mg Tablet (fed) in Treatment period 1; Treatment B: CVN424 150 mg Tablet (fasted) in period 2 and Treatment A: CVN424 150 mg suspension (fasted) in period 3. There was a washout period of 14 days between each treatment period.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.6 Years
STANDARD_DEVIATION 9.07 • n=5 Participants
|
36.0 Years
STANDARD_DEVIATION 8.94 • n=7 Participants
|
39.6 Years
STANDARD_DEVIATION 10.11 • n=5 Participants
|
38.2 Years
STANDARD_DEVIATION 7.11 • n=4 Participants
|
37.6 Years
STANDARD_DEVIATION 12.54 • n=21 Participants
|
48.0 Years
STANDARD_DEVIATION 3.29 • n=8 Participants
|
39.6 Years
STANDARD_DEVIATION 9.09 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dosePopulation: PK Analysis Set consists of all participants who received study drug and had at least 1 measurable plasma concentration. Only those participants with data available at specified timepoints have been presented.
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Treatment A: CVN424 150 mg Suspension (Fasted)
n=30 Participants
Participants were randomized to receive single oral dose of 150 mg CVN424 suspension under fasted condition.
|
Treatment B: CVN424 150 mg Tablet (Fasted)
n=26 Participants
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fasted condition.
|
Treatment C: CVN424 150 mg Tablet (Fed)
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fed condition.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Measured Non Zero Concentration (AUC0-t) of CVN424 Suspension Fasted and Tablet Fasted
|
16790 Hours*nanograms per milliliter
Geometric Coefficient of Variation 19.3
|
10100 Hours*nanograms per milliliter
Geometric Coefficient of Variation 31.8
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dosePopulation: PK Analysis Set. Only those participants with data available at specified timepoints have been presented.
Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Treatment A: CVN424 150 mg Suspension (Fasted)
n=30 Participants
Participants were randomized to receive single oral dose of 150 mg CVN424 suspension under fasted condition.
|
Treatment B: CVN424 150 mg Tablet (Fasted)
n=26 Participants
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fasted condition.
|
Treatment C: CVN424 150 mg Tablet (Fed)
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fed condition.
|
|---|---|---|---|
|
Area Under the Plasma Concentration Time Curve From Time 0 to 96 Hours (AUC 0-96h) of CVN424 Suspension Fasted and Tablet Fasted
|
16780 Hours*nanograms per milliliter
Geometric Coefficient of Variation 19.3
|
10100 Hours*nanograms per milliliter
Geometric Coefficient of Variation 31.8
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dosePopulation: PK Analysis Set. Only those participants with data available at specified timepoints have been presented.
Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Treatment A: CVN424 150 mg Suspension (Fasted)
n=30 Participants
Participants were randomized to receive single oral dose of 150 mg CVN424 suspension under fasted condition.
|
Treatment B: CVN424 150 mg Tablet (Fasted)
n=26 Participants
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fasted condition.
|
Treatment C: CVN424 150 mg Tablet (Fed)
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fed condition.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of CVN424 Suspension Fasted and Tablet Fasted
|
812.9 nanograms per milliliter
Geometric Coefficient of Variation 28.9
|
231.1 nanograms per milliliter
Geometric Coefficient of Variation 40.6
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dosePopulation: PK Analysis Set. Only those participants with data available at specified timepoints have been presented.
Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Treatment A: CVN424 150 mg Suspension (Fasted)
n=30 Participants
Participants were randomized to receive single oral dose of 150 mg CVN424 suspension under fasted condition.
|
Treatment B: CVN424 150 mg Tablet (Fasted)
n=26 Participants
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fasted condition.
|
Treatment C: CVN424 150 mg Tablet (Fed)
n=31 Participants
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fed condition.
|
|---|---|---|---|
|
Time to Reach Cmax (Tmax) of CVN424 Suspension and Tablet
|
2.040 hours
Interval 1.0 to 3.08
|
3.526 hours
Interval 1.5 to 48.09
|
4.055 hours
Interval 2.05 to 6.07
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dosePopulation: PK Analysis Set. Only those participants with data available at specified timepoints have been presented.
Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Treatment A: CVN424 150 mg Suspension (Fasted)
n=30 Participants
Participants were randomized to receive single oral dose of 150 mg CVN424 suspension under fasted condition.
|
Treatment B: CVN424 150 mg Tablet (Fasted)
n=26 Participants
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fasted condition.
|
Treatment C: CVN424 150 mg Tablet (Fed)
n=31 Participants
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fed condition.
|
|---|---|---|---|
|
Time Taken for Drug to Appear in Systemic Circulation Following Administration (Tlag) of CVN424 Suspension and Tablet
|
0.00 hours
Interval 0.0 to 0.0
|
0.00 hours
Interval 0.0 to 0.0
|
0.00 hours
Interval 0.0 to 1.51
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dosePopulation: PK Analysis Set. Only those participants with data available at specified timepoints have been presented.
Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Treatment A: CVN424 150 mg Suspension (Fasted)
n=26 Participants
Participants were randomized to receive single oral dose of 150 mg CVN424 suspension under fasted condition.
|
Treatment B: CVN424 150 mg Tablet (Fasted)
n=31 Participants
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fasted condition.
|
Treatment C: CVN424 150 mg Tablet (Fed)
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fed condition.
|
|---|---|---|---|
|
AUC(0-t) of CVN424 Tablet Fed and Tablet Fasted
|
10100 Hours*nanograms per milliliter
Geometric Coefficient of Variation 31.8
|
16340 Hours*nanograms per milliliter
Geometric Coefficient of Variation 20.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dosePopulation: PK Analysis Set. Only those participants with data available at specified timepoints have been presented.
Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Treatment A: CVN424 150 mg Suspension (Fasted)
n=26 Participants
Participants were randomized to receive single oral dose of 150 mg CVN424 suspension under fasted condition.
|
Treatment B: CVN424 150 mg Tablet (Fasted)
n=31 Participants
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fasted condition.
|
Treatment C: CVN424 150 mg Tablet (Fed)
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fed condition.
|
|---|---|---|---|
|
AUC(0-96 Hrs) of CVN424 Tablet Fed and Tablet Fasted
|
10100 Hours*nanograms per milliliter
Geometric Coefficient of Variation 31.8
|
16340 Hours*nanograms per milliliter
Geometric Coefficient of Variation 20.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dosePopulation: PK Analysis Set. Only those participants with data available at specified timepoints have been presented.
Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Treatment A: CVN424 150 mg Suspension (Fasted)
n=26 Participants
Participants were randomized to receive single oral dose of 150 mg CVN424 suspension under fasted condition.
|
Treatment B: CVN424 150 mg Tablet (Fasted)
n=31 Participants
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fasted condition.
|
Treatment C: CVN424 150 mg Tablet (Fed)
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fed condition.
|
|---|---|---|---|
|
Cmax of CVN424 Tablet Fed and Tablet Fasted
|
231.1 Nanograms per milliliter
Geometric Coefficient of Variation 40.6
|
693.8 Nanograms per milliliter
Geometric Coefficient of Variation 23.5
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dosePopulation: PK Analysis Set. Only those participants with data available at specified timepoints have been presented.
Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Treatment A: CVN424 150 mg Suspension (Fasted)
n=26 Participants
Participants were randomized to receive single oral dose of 150 mg CVN424 suspension under fasted condition.
|
Treatment B: CVN424 150 mg Tablet (Fasted)
n=31 Participants
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fasted condition.
|
Treatment C: CVN424 150 mg Tablet (Fed)
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fed condition.
|
|---|---|---|---|
|
Tmax of CVN424 Tablet Fed and Tablet Fasted
|
3.526 hours
Interval 1.5 to 48.09
|
4.055 hours
Interval 2.05 to 6.07
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dosePopulation: PK Analysis Set. Only those participants with data available at specified timepoints have been presented.
Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Treatment A: CVN424 150 mg Suspension (Fasted)
n=26 Participants
Participants were randomized to receive single oral dose of 150 mg CVN424 suspension under fasted condition.
|
Treatment B: CVN424 150 mg Tablet (Fasted)
n=31 Participants
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fasted condition.
|
Treatment C: CVN424 150 mg Tablet (Fed)
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fed condition.
|
|---|---|---|---|
|
Tlag of CVN424 Tablet Fed and Tablet Fasted
|
0.00 hours
Interval 0.0 to 0.0
|
0.00 hours
Interval 0.0 to 1.51
|
—
|
SECONDARY outcome
Timeframe: Up to Day 35Population: Safety Analysis Set.
An adverse event is any untoward medical occurrence in a clinical research study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug.
Outcome measures
| Measure |
Treatment A: CVN424 150 mg Suspension (Fasted)
n=30 Participants
Participants were randomized to receive single oral dose of 150 mg CVN424 suspension under fasted condition.
|
Treatment B: CVN424 150 mg Tablet (Fasted)
n=30 Participants
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fasted condition.
|
Treatment C: CVN424 150 mg Tablet (Fed)
n=32 Participants
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fed condition.
|
|---|---|---|---|
|
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs)
|
8 Participants
|
11 Participants
|
11 Participants
|
Adverse Events
Treatment A: CVN424 150 mg Suspension (Fasted)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Treatment B: CVN424 150 mg Tablet (Fasted)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Treatment C: CVN424 150 mg Tablet (Fed)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A: CVN424 150 mg Suspension (Fasted)
n=30 participants at risk
Participants were randomized to receive single oral dose of 150 mg CVN424 suspension under fasted condition.
|
Treatment B: CVN424 150 mg Tablet (Fasted)
n=30 participants at risk
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fasted condition.
|
Treatment C: CVN424 150 mg Tablet (Fed)
n=32 participants at risk
Participants were randomized to receive a single oral dose of 150 mg CVN424 tablet under fed condition.
|
|---|---|---|---|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.1%
1/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal oedema
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.1%
1/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.1%
1/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
6.2%
2/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
6.2%
2/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
9.4%
3/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.1%
1/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.1%
1/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Vascular disorders
Peripheral coldness
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Gastrointestinal disorders
Flatulence
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
2/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
6.7%
2/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.1%
1/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.1%
1/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
General disorders
Chest pain
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
General disorders
Chills
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
General disorders
Fatigue
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.1%
1/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
General disorders
Vessel puncture site bruise
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
General disorders
Vessel puncture site pain
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.1%
1/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Infections and infestations
Urinary tract infection
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Nervous system disorders
Dizziness
|
10.0%
3/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.1%
1/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Nervous system disorders
Head discomfort
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Nervous system disorders
Headache
|
10.0%
3/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
13.3%
4/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
15.6%
5/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Nervous system disorders
Tremor
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Eye disorders
Asthenopia
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.1%
1/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Eye disorders
Dry eye
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.1%
1/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Eye disorders
Vision blurred
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
6.2%
2/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.3%
1/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.1%
1/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
3/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
10.0%
3/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
9.4%
3/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.1%
1/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
0.00%
0/30 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the study drug.
|
3.1%
1/32 • Up to Day 35
Adverse events were collected in Safety analysis set that consist of all participants who were enrolled and received the 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