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
Condition: Heathy Volunteer
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): CC-90001; Omeprazole; Midazolam; Warfarin; Vitamin K; Rosuvastatin; Metformin; Digoxin; Nintedanib
Intervention type(s): Drug; Drug; Drug; Drug; Dietary Supplement; Drug; Drug; Drug; Drug
Intervention description(s): CC-90001; Omeprazole; Midazolam; Warfarin; Vitamin K; Rosuvastatin; Metformin; Digoxin; Nintedanib
Intervention MeSH terms: Vitamin K; Metformin; Nintedanib; Digoxin; Midazolam; Omeprazole; Warfarin; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteer; CC-90001; Pharmacokinetics; Omeprazole; Midazolam; Warfarin; Rosuvastatin; Metformin; Digoxin; Nintedanib