Trial Outcomes & Findings for A Study of the Metabolic Profile of Dalcetrapib in Healthy Volunteers (NCT NCT01476267)
NCT ID: NCT01476267
Last Updated: 2019-12-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
6 participants
Primary outcome timeframe
up to Day 5
Results posted on
2019-12-17
Participant Flow
Participant milestones
| Measure |
Single Arm
dalcetrapib: Single oral radiolabeled dose
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Metabolic Profile of Dalcetrapib in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Single Arm
n=6 Participants
dalcetrapib: Single oral radiolabeled dose
|
|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 4.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to Day 5Outcome measures
| Measure |
Single Arm
n=6 Participants
dalcetrapib: Single oral radiolabeled dose
|
|---|---|
|
Metabolic Profile: Percentage of Free Thiophenol M1 in the Blood Plasma
|
37.5 Percentage of Free Thiophenol M1
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: approximately 3 monthsPopulation: Data was not collected
Outcome measures
Outcome data not reported
Adverse Events
Single Arm
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Arm
n=6 participants at risk
dalcetrapib: Single oral radiolabeled dose
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6
|
|
Gastrointestinal disorders
Abdominal Distension
|
16.7%
1/6
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
1/6
|
|
Gastrointestinal disorders
Toothache
|
16.7%
1/6
|
|
Nervous system disorders
Headache
|
33.3%
2/6
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
16.7%
1/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place