Overview

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

Status:
Completed

Trial end date:
2018-07-29

Target enrollment:

Participant gender:

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

Phase:

Phase 1

Details

Lead Sponsor:

Celgene

Treatments:

Digoxin
Metformin
Midazolam
Nintedanib
Omeprazole
Rosuvastatin Calcium
Vitamin K
Warfarin