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Study Evaluating the Effects of Food, Cytochrome P450 Inhibition and Induction on the Pharmacokinetics of CC-122

NCT03340662 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2019-01-16

No results posted yet for this study

Summary

This is a phase 1 open-label 4-part study to evaluate the effect of food, cytochrome P450 inhibition and induction on the pharmacokinetics of CC 122 in healthy adult subjects. Approximately 81 subjects will be enrolled. There will be approximately 24 subjects in Part 1 and approximately 19 subjects in Parts 2, 3, and 4, respectively. Subjects may participate in 1 part only.

Conditions

  • Healthy Volunteer

Interventions

DRUG

CC-122

CC-122

DRUG

Itraconazole

CYP3A Inhibitor

DRUG

Fluvoxamine

CYP1A2 Inhibitor

DRUG

Rifampin

CYP3A Inducer

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Leon Carayannopoulos, MD · Celgene Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-11-09
Primary Completion
2018-01-27
Completion
2018-01-27
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 NCT03340662 on ClinicalTrials.gov