NCT03340662

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

A Phase 1, Open-Label, 4-Part Study to Evaluate the Effect of Food, Cytochrome P 450 Inhibition and Induction on the Pharmacokinetics of CC 122 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

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. Part 1: On Day 1 of Period 1, eligible subjects will be randomized to 1 of 2 sequences. On Day 1 of each study period, each subject will receive 1 of 2 treatments according to the sequence in which he or she is randomized. In Part 2, subjects will receive a single dose of CC-122 in Period 1 and, following an appropriate washout, multiple doses of itraconazole plus one dose of itraconazole with CC-122 in Period 2. In Part 3, subjects will receive a single dose of CC-122 in Period 1 and, following an appropriate washout, multiple doses of fluvoxamine plus one dose of fluvoxamine with CC-122 in Period 2. In Part 4, subjects will receive a single dose of CC-122 in Period 1 and, following an appropriate washout, multiple doses of rifampin plus one dose of rifampin with CC-122 in Period 2.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	CC-122	CC-122
DRUG	Itraconazole	CYP3A Inhibitor
DRUG	Fluvoxamine	CYP1A2 Inhibitor
DRUG	Rifampin	CYP3A Inducer

Timeline

• Start date: 2017-11-09
• Primary completion: 2018-01-27
• Completion: 2018-01-27
• First posted: 2017-11-13
• Last updated: 2019-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study