A Phase 1 interventional study of CC-90001 in Healthy Volunteer, sponsored by Celgene. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-08.
Sponsored by Celgene · Phase 1, Interventional, and Other
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).
Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.
Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects must satisfy all of the following criteria to be enrolled in the study:
Exclusion Criteria:
100 mg of CC-90001 (once daily \[QD\] x 7 days) will be given orally
Drug: CC-90001
200 mg of CC-90001 (once daily \[QD\] x 7 days) will be given orally
Drug: CC-90001
400 mg of CC-90001 (once daily \[QD\] x 7 days) will be given orally
Drug: CC-90001
CC-90001
Pharmacokinetic- AUC0-t
Area under the plasma concentration-time curve from time zero to the time point of the last measurable concentration
Time frame: Day 1 and Day 7- 10
Pharmacokinetic- AUC0-∞
Area under the plasma concentration-time curve from time zero to infinity
Time frame: Day 1 and Day 7- 10
Pharmacokinetic- CL/F
Estimation of apparent clearance of drug from plasma after extravascular administration
Time frame: Day 1 and Day 7- 10
Pharmacokinetic- Vz/F
Estimation of apparent volume of distribution during the terminal phase
Time frame: Day 1 and Day 7- 10
Pharmacokinetic- Cmax
Estimation of observed maximum plasma concentration
Time frame: Day 1 and Day 7
Pharmacokinetic- Tmax
Estimation of time to Cmax
Time frame: Day 1 and Day 7
Pharmacokinetic- t1/2
Description: Estimation of terminal elimination half-life
Time frame: Day 1 and Day 7- 10
Adverse Events (AEs)
Number participants with Adverse Event
Time frame: From enrollment until at least 28 days after completion of study treatment
Plan to share: Yes — 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 information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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