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

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

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).

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: CC-90001

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Paraxel International

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Celgene

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2019
• Primary Completion (Actual): June 13, 2019
• Study Completion (Actual): June 13, 2019

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 8, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Japanese; Healthy Subjects; CC-90001; Caucasian
• Other Study ID Numbers: CC-90001-CP-006; U1111-1229-5813

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No