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NCT Number: NCT03958864

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

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Key information

Conditions

Healthy Volunteer

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Paraxel International

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • 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.

Treatment and study plan

CC-90001

Drug

CC-90001

Primary outcomes

  1. Pharmacokinetic- AUC0-t

    Time frame: Day 1 and Day 7- 10

    Area under the plasma concentration-time curve from time zero to the time point of the last measurable concentration

  2. Pharmacokinetic- AUC0-∞

    Time frame: Day 1 and Day 7- 10

    Area under the plasma concentration-time curve from time zero to infinity

  3. Pharmacokinetic- CL/F

    Time frame: Day 1 and Day 7- 10

    Estimation of apparent clearance of drug from plasma after extravascular administration

  4. Pharmacokinetic- Vz/F

    Time frame: Day 1 and Day 7- 10

    Estimation of apparent volume of distribution during the terminal phase

  5. Pharmacokinetic- Cmax

    Time frame: Day 1 and Day 7

    Estimation of observed maximum plasma concentration

  6. Pharmacokinetic- Tmax

    Time frame: Day 1 and Day 7

    Estimation of time to Cmax

  7. Pharmacokinetic- t1/2

    Time frame: Day 1 and Day 7- 10

    Description: Estimation of terminal elimination half-life

Secondary outcomes

  1. Adverse Events (AEs)

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

    Number participants with Adverse Event

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 22, 2019
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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