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 range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.