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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: CC-90001

• Registration Number: NCT03958864
• Lead Sponsor: Celgene

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-04
• Study First Submitted: 2019-05-20
• Study First Submitted QC: 2019-05-20
• Study First Posted: 2019-05-22
• Primary Completion: 2019-06-13
• Study Completion: 2019-06-13
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-06
• Last Update Posted: 2020-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CC-90001 100 mg	CC-90001	100 mg of CC-90001 (once daily \[QD\] x 7 days) will be given orally
CC-90001 400 mg	CC-90001	400 mg of CC-90001 (once daily \[QD\] x 7 days) will be given orally
CC-90001 200 mg	CC-90001	200 mg of CC-90001 (once daily \[QD\] x 7 days) will be given orally

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Adverse Events (AEs)	From enrollment until at least 28 days after completion of study treatment	Number participants with Adverse Event

Trial Locations

Locations (1)

Paraxel International; 🇺🇸 Glendale, California, United States