Healthy Volunteer
Conditions
Keywords
Healthy Subjects, CC-90001, Japanese, Caucasian, Safety, Pharmacokinetics
Brief summary
This is a Phase 1, open-label, randomized, parallel design study to evaluate the PK and safety/tolerability of CC 90001 in Japanese and Caucasian healthy adult subjects. The study will consist of multiple oral doses of IP (QD x 7 days) in 3 planned dose level cohorts of 100 mg, 200 mg, and 400 mg. Each cohort will have 20 subjects (10 Japanese subjects and 10 Caucasian subjects, with a minimum of 8 subjects to complete in each group) who will receive IP (see below).
Interventions
DRUGCC-90001
CC-90001
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects must satisfy all of the following criteria to be enrolled in the study: 1. Healthy, adult, male and female subjects. 2. Japanese subjects who were born in Japan and not have lived outside of Japan for more than 10 years, have both parents and grandparents of Japanese origin, and have not significantly modified their diets since leaving Japan. 3. Caucasian subjects who have age and body mass index matched with Japanese subjects.
Exclusion criteria
1. Has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study or place the subject at unacceptable risk if he/she were to participate in the study. 2. Use of any prescribed systemic or topical medication within 30 days of the first dose administration. 3. Has any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, and excretion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic- t1/2 | Day 1 and Day 7- 10 | Description: Estimation of terminal elimination half-life |
| Pharmacokinetic- AUC0-t | Day 1 and Day 7- 10 | Area under the plasma concentration-time curve from time zero to the time point of the last measurable concentration |
| Pharmacokinetic- AUC0-∞ | Day 1 and Day 7- 10 | Area under the plasma concentration-time curve from time zero to infinity |
| Pharmacokinetic- CL/F | Day 1 and Day 7- 10 | Estimation of apparent clearance of drug from plasma after extravascular administration |
| Pharmacokinetic- Vz/F | Day 1 and Day 7- 10 | Estimation of apparent volume of distribution during the terminal phase |
| Pharmacokinetic- Cmax | Day 1 and Day 7 | Estimation of observed maximum plasma concentration |
| Pharmacokinetic- Tmax | Day 1 and Day 7 | Estimation of time to Cmax |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs) | From enrollment until at least 28 days after completion of study treatment | Number participants with Adverse Event |
Countries
United States
Outcome results
None listed