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
This study will consist of 4 parts. Each part has two periods. The parts may be conducted in any order. Subjects may participate in 1 part only. Each subject will participate in a screening phase, a baseline phase in each study period, a treatment phase in each study period and a follow-up telephone call. Subjects will be screened for eligibility. Eligible subjects will return to the study center on Day -1 of Period 1 and will remain at the study center until the last day of Period 2. In Part 1, Single doses of omeprazole, midazolam, warfarin, and vitamin K will be administered under fasted conditions on Period 1, Day 1. During Period 2, subjects will receive once daily (QD) doses of CC-90001 from Days 1 through 18. On the day of dosing with probe drugs, CC-90001 will be dosed following an overnight fast. On all other days, CC-90001 can be dosed without regard to food. On Period 2, Day 14, subjects will also be administered single doses of omeprazole, midazolam, warfarin, and vitamin K under fasted conditions. In Part 2, A single dose of rosuvastatin will be administered under fasted conditions on Period 1, Day 1. There will be a washout period of 5 to 10 days between Period 1, Day 1 and Period 2, Day 1. During Period 2, subjects will receive QD doses of CC-90001 from Days 1 through 6. On the day of dosing with probe drug, CC-90001 will be dosed following an overnight fast. On all other days, CC 90001 can be dosed without regard to food. On Period 2, Day 5, subjects will also be administered a single dose of rosuvastatin under fasted conditions. In Part 3, single doses of metformin and digoxin will be administered under fasted conditions on Period 1, Day 1. There will be a washout period of 5 to 10 days between Period 1, Day 1 and Period 2, Day 1. During Period 2, subjects will receive QD doses of CC-90001 from Days 1 through 6. On the day of dosing with probe drugs, CC-90001 will be dosed following an overnight fast. On all other days, CC 90001 can be dosed without regard to food. On Period 2, Day 5, subjects will also be administered single doses of metformin and digoxin under fasted conditions. In Part 4, a single dose of nintedanib will be administered 30 minutes after the start of a standard breakfast on Period 1, Day 1. There will be a washout period of 5 to 10 days between Period 1, Day 1 and Period 2, Day 1. During Period 2, subjects will receive QD doses of CC-90001 from Days 1 through 14. On the day of dosing with probe drug, CC 90001 will be dosed 30 minutes after the start of a standard breakfast. On all other days, CC 90001 can be dosed without regard to food. On Period 2, Day 14, subjects will also be administered a single dose of nintedanib 30 minutes after the start of a standard breakfast.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
CC-90001
Omeprazole
Midazolam
Warfarin
Vitamin K
Rosuvastatin
Metformin
Digoxin
Nintedanib
Covance Clinical Research Unit
Daytona Beach, Florida, United States
Pharmacokinetic- Cmax
Maximum observed plasma concentration
Time frame: up to approximately 2.5 months
Pharmacokinetic- AUC0-t
AUC from time zero to the last quantifiable concentration
Time frame: up to approximately 2.5 months
Adverse Events (AEs)
Number of participants with adverse events
Time frame: From enrollment until at least 28 days after completion of study treatment
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