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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

NCT03363815 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2019-01-25

No results posted yet for this study

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

Conditions

  • Heathy Volunteer

Interventions

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

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Francisco Ramirez-Valle, MD, PhD. · Celgene

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-04
Primary Completion
2018-07-29
Completion
2018-07-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03363815 on ClinicalTrials.gov