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

NCT03958864 | Completed Phase 1 FDA Drug

• 2 other identifiers: CC-90001-CP-006U1111-1229-5813
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Volunteer

Keywords

Healthy Subjects; CC-90001; Japanese; Caucasian; Safety; Pharmacokinetics

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Adverse Events (AEs)

  From enrollment until at least 28 days after completion of study treatment

Study Arms (3)

CC-90001 100 mg

EXPERIMENTAL

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

Drug: CC-90001

CC-90001 200 mg

EXPERIMENTAL

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

Drug: CC-90001

CC-90001 400 mg

EXPERIMENTAL

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

Drug: CC-90001

Interventions

CC-90001 DRUG

CC-90001

CC-90001 100 mg; CC-90001 200 mg; CC-90001 400 mg

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Paraxel International

Glendale, California, 91206, United States

Location

MeSH Terms

Interventions

CC-90001

Study Officials

• Ying Ye, PhD

  Celgene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 22, 2019
• Study Start: April 4, 2019
• Primary Completion: June 13, 2019
• Study Completion: June 13, 2019
• Last Updated: May 8, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (1)