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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03958864
• Other study ID #: CC-90001-CP-006
• Secondary ID: U1111-1229-5813
• Status: Completed
• Phase: Phase 1
• Start date: April 4, 2019
• Est. completion date: June 13, 2019

Study information

• Verified date: May 2020
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 13, 2019
• Est. primary completion date: June 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• CC-90001
CC-90001

Locations

Country	Name	City	State
United States	Paraxel International	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pharmacokinetic- AUC0-8	Area under the plasma concentration-time curve from time zero to infinity	Day 1 and Day 7- 10
Primary	Pharmacokinetic- CL/F	Estimation of apparent clearance of drug from plasma after extravascular administration	Day 1 and Day 7- 10
Primary	Pharmacokinetic- Vz/F	Estimation of apparent volume of distribution during the terminal phase	Day 1 and Day 7- 10
Primary	Pharmacokinetic- Cmax	Estimation of observed maximum plasma concentration	Day 1 and Day 7
Primary	Pharmacokinetic- Tmax	Estimation of time to Cmax	Day 1 and Day 7
Primary	Pharmacokinetic- t1/2	Description: Estimation of terminal elimination half-life	Day 1 and Day 7- 10
Secondary	Adverse Events (AEs)	Number participants with Adverse Event	From enrollment until at least 28 days after completion of study treatment