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

NCT03958864 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-05-08

No results posted yet for this study

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).

Conditions

  • Healthy Volunteer

Interventions

DRUG

CC-90001

CC-90001

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Ying Ye, PhD · Celgene

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-04
Primary Completion
2019-06-13
Completion
2019-06-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03958864 on ClinicalTrials.gov