NCT03363815

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

A Phase 1, Four-part, Fixed-sequence, Open-label 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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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

Detailed description

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.

Conditions

• Heathy Volunteer

Interventions

Type	Name	Description
DRUG	CC-90001	CC-90001
DRUG	Omeprazole	Omeprazole
DRUG	Midazolam	Midazolam
DRUG	Warfarin	Warfarin
DIETARY_SUPPLEMENT	Vitamin K	Vitamin K
DRUG	Rosuvastatin	Rosuvastatin
DRUG	Metformin	Metformin
DRUG	Digoxin	Digoxin
DRUG	Nintedanib	Nintedanib

Timeline

• Start date: 2017-12-04
• Primary completion: 2018-07-29
• Completion: 2018-07-29
• First posted: 2017-12-06
• Last updated: 2019-01-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study