A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Dose CC-90001 in Japanese and Caucasian Healthy Subjects

Study Overview
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Brief Summary
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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).

Official Title
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A PHASE 1, OPEN LABEL STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY/TOLERABILITY OF CC-90001 IN JAPANESE HEALTHY SUBJECTS

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: CC-90001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must satisfy all of the following criteria to be enrolled in the study: Healthy, adult, male and female subjects. 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. Caucasian subjects who have age and body mass index matched with Japanese subjects. Exclusion Criteria: 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. Use of any prescribed systemic or topical medication within 30 days of the first dose administration. Has any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, and excretion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CC-90001 100 mg<br>100 mg of CC-90001 (once daily [QD] x 7 days) will be given orally | Drug: CC-90001<br>* CC-90001<br>|
| Experimental: CC-90001 200 mg<br>200 mg of CC-90001 (once daily [QD] x 7 days) will be given orally | Drug: CC-90001<br>* CC-90001<br>|
| Experimental: CC-90001 400 mg<br>400 mg of CC-90001 (once daily [QD] x 7 days) will be given orally | Drug: CC-90001<br>* CC-90001<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic- AUC0-t | Area under the plasma concentration-time curve from time zero to the time point of the last measurable concentration | Day 1 and Day 7- 10 | 
| Pharmacokinetic- AUC0-∞ | Area under the plasma concentration-time curve from time zero to infinity | Day 1 and Day 7- 10 | 
| Pharmacokinetic- CL/F | Estimation of apparent clearance of drug from plasma after extravascular administration | Day 1 and Day 7- 10 | 
| Pharmacokinetic- Vz/F | Estimation of apparent volume of distribution during the terminal phase | Day 1 and Day 7- 10 | 
| Pharmacokinetic- Cmax | Estimation of observed maximum plasma concentration | Day 1 and Day 7 | 
| Pharmacokinetic- Tmax | Estimation of time to Cmax | Day 1 and Day 7 | 
| Pharmacokinetic- t1/2 | Description: Estimation of terminal elimination half-life | Day 1 and Day 7- 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AEs) | Number participants with Adverse Event | From enrollment until at least 28 days after completion of study treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Subjects, CC-90001, Japanese, Caucasian, Safety, Pharmacokinetics