Trial Outcomes & Findings for Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649 (NCT NCT01154764)
NCT ID: NCT01154764
Last Updated: 2024-01-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 240, 384, and 480 hours post-dose
Results posted on
2024-01-03
Participant Flow
Participant milestones
| Measure |
Group 1
Period 1: CG100649 (1 mg x 6 capsules) once a day, 1 Day Period 2: CG100649 (1 mg x 6 capsules) and ketoconazole tablets (200 mg x 2 tablets) together on Day 1, followed by additional ketoconazole tablets (200 mg x 2 tablets) once a day for 4 days (Days 2-5), for a total of 5 days.
|
Group 2
Period 1: CG100649 (1 mg x 6 capsules) and ketoconazole tablets (200 mg x 2 tablets) together on Day 1, followed by additional ketoconazole tablets (200 mg x 2 tablets) once a day for 4 days (Days 2-5), for a total of 5 days.
Period 2: CG100649 (1 mg x 6 capsules) once a day, 1 Day
|
|---|---|---|
|
Intervention 1 (5days)
STARTED
|
14
|
14
|
|
Intervention 1 (5days)
COMPLETED
|
14
|
14
|
|
Intervention 1 (5days)
NOT COMPLETED
|
0
|
0
|
|
Intervention 2 (5days)
STARTED
|
14
|
14
|
|
Intervention 2 (5days)
COMPLETED
|
13
|
13
|
|
Intervention 2 (5days)
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649
Baseline characteristics by cohort
| Measure |
Group 1 and Group 2
n=28 Participants
Overall Demographic Character
|
|---|---|
|
Age, Continuous
|
26.3 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Height
|
173.2 centimeters
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Weight
|
67.0 kilograms
STANDARD_DEVIATION 7.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 240, 384, and 480 hours post-doseOutcome measures
| Measure |
CG100649 6mg + Ketoconazole 400 mg
n=28 Participants
CG100649 (1 mg x 6 capsules) and ketoconazole tablets (200 mg x 2 tablets) together on Day 1, followed by additional ketoconazole tablets (200 mg x 2 tablets), once a day for 4 days (Days 2-5), for a total of 5 days.
|
CG100649 6mg Single Dosing
n=28 Participants
CG100649 (1 mg x 6 capsules) once a day single dose
|
|---|---|---|
|
Cmax
|
11.0 ng/mL
Standard Deviation 2.4
|
107 ng/mL
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 240, 384, and 480 hours post-doseOutcome measures
| Measure |
CG100649 6mg + Ketoconazole 400 mg
n=28 Participants
CG100649 (1 mg x 6 capsules) and ketoconazole tablets (200 mg x 2 tablets) together on Day 1, followed by additional ketoconazole tablets (200 mg x 2 tablets), once a day for 4 days (Days 2-5), for a total of 5 days.
|
CG100649 6mg Single Dosing
n=28 Participants
CG100649 (1 mg x 6 capsules) once a day single dose
|
|---|---|---|
|
AUClast
|
2685.8 h∙ng/mL
Standard Deviation 551.1
|
2074 h∙ng/mL
Standard Deviation 442.9
|
Adverse Events
CG100649 6mg Single Dosing
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
CG100649+ Ketoconazole
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CG100649 6mg Single Dosing
n=28 participants at risk
CG100649 (1 mg x 6 capsules), once a day
|
CG100649+ Ketoconazole
n=28 participants at risk
CG100649 (1 mg x 6 capsules) and ketoconazole tablets (200 mg x 2 tablets) together on Day 1, followed by additional ketoconazole tablets (200 mg x 2 tablets), once a day for 4 days (Days 2-5), for a total of 5 days.
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
3.6%
1/28 • up to 8 weeks
|
3.6%
1/28 • up to 8 weeks
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
3.6%
1/28 • up to 8 weeks
|
3.6%
1/28 • up to 8 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/28 • up to 8 weeks
|
3.6%
1/28 • up to 8 weeks
|
|
Infections and infestations
Hematuria
|
3.6%
1/28 • up to 8 weeks
|
0.00%
0/28 • up to 8 weeks
|
|
Infections and infestations
Pyuria
|
3.6%
1/28 • up to 8 weeks
|
0.00%
0/28 • up to 8 weeks
|
|
Nervous system disorders
Headache
|
3.6%
1/28 • up to 8 weeks
|
10.7%
3/28 • up to 8 weeks
|
|
Vascular disorders
Clavicle Fractuer
|
3.6%
1/28 • up to 8 weeks
|
0.00%
0/28 • up to 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
7.1%
2/28 • up to 8 weeks
|
3.6%
1/28 • up to 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
3.6%
1/28 • up to 8 weeks
|
3.6%
1/28 • up to 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER