A Study to Evaluate the Effect of Multiple Doses of CC-90001 on the Pharmacokinetics of Omeprazol… (NCT03363815) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Effect of Multiple Doses of CC-90001 on the Pharmacokinetics of Omeprazole, Midazolam, Warfarin, Rosuvastatin, Metformin, Digoxin, and Nintedanib in Healthy Adult Subjects
United States56 participantsStarted 2017-12-04
Plain-language summary
This is a four-part study to evaluate the effect of multiple doses of CC-90001 on the PK, safety, and tolerability of single doses of omeprazole, midazolam, warfarin, rosuvastatin, metformin, digoxin, and nintedanib in healthy subjects. Each study part is a nonrandomized, fixed-sequence, open-label, two-period study. The study parts can be run in any order and can be, but do not have to be, run in parallel. Subjects may participate in one part only. For each part, each subject will participate as follows:
* Screening (Days -21 through -2)
* Baseline phase for each study period (Periods 1 and 2)
* Treatment phase for each study period (Periods 1 and 2)
* Follow-up telephone call
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion Criteria:
Subjects must satisfy all of the following criteria to be eligible for enrollment into the study:
* Must understand and voluntarily sign a written informed consent form (ICF) prior to any study-related assessments/procedures being performed.
* Must be able to communicate with the investigator and to understand and adhere to the study visit schedule and other protocol requirements.
* Must be a male or female of any race, aged ≥ 18 to ≤ 64 years of age (inclusive) at the time of signing the ICF.
* Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing during the course of the study and at the end of the study. This applies even if the subject practices true abstinence from heterosexual contact. Note: Females of childbearing potential are not permitted in Part 4.
* Part 4 only: Female subjects must be of nonchildbearing potential as confirmed by medical history. Females of childbearing potential are permitted in Parts 1, 2, and 3.
* Male subjects must practice true abstinence from heterosexual contact (which must be reviewed on a monthly basis, as applicable) or agree to use a male condom (latex or nonlatex condom not made out of natural \[animal\] membrane \[eg, polyurethane\]) during sexual contact with a pregnant female or a FCBP while participating in the study and for at least 28 days after the last dose of study drug, even if he has undergone a successful vasectomy as confirmed by medical history.
* Must have a body mass inde…