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

Celgene

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: CC-90001

Study type: Interventional

Funder types: Industry

Identifiers

NCT03958864

CC-90001-CP-006

U1111-1229-5813

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 3 patient groups

CC-90001 100 mg

Experimental group

Description:

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

Treatment:

Drug: CC-90001

CC-90001 200 mg

Experimental group

Description:

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

Treatment:

Drug: CC-90001

CC-90001 400 mg

Experimental group

Description:

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

Treatment:

Drug: CC-90001