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

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ClinicalTrials.gov Identifier: NCT03958864
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

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).


Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: CC-90001 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1, Open-label Study to Evaluate the Pharmacokinetics and Safety/Tolerability of Multiple-Dose CC-90001 in Japanese and Caucasian Healthy Subjects
Actual Study Start Date : April 4, 2019
Estimated Primary Completion Date : June 10, 2019
Estimated Study Completion Date : June 10, 2019

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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: From enrollment until at least 28 days after completion of study treatment ]
    Number participants with Adverse Event



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958864


Contacts
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Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
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United States, California
Paraxel International Recruiting
Glendale, California, United States, 91206
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Ying Ye, PhD Celgene

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03958864     History of Changes
Other Study ID Numbers: CC-90001-CP-006
U1111-1229-5813
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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/

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Healthy Subjects
CC-90001
Japanese
Caucasian
Safety
Pharmacokinetics