NCT02110420

First-in-human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of CC-90001

A Phase 1, Randomized, Two-part Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of CC-90001 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Celgene Corporation · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

First-in-human study to evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of CC-90001

Detailed description

This is a 2-part study to be conducted at a single study center. Part 1 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of CC-90001 following a single oral dose in healthy subjects. During the course of Part 1, each subject will participate in a screening phase, a baseline phase, a treatment phase and a follow up visit. There will be a total of 7 planned cohorts, each of which will consist of a different dose level, with 8 subjects per cohort. In each cohort, 6 subjects will receive a dose of CC 90001 and 2 subjects will receive placebo depending on the randomization schedule. Administration of study drug at the next higher dose level will not begin until the safety and tolerability of the preceding dose have been evaluated and deemed acceptable by the investigator and sponsor's medical monitor. Part 2 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of CC-90001 following multiple oral doses in healthy subjects. Only doses that are safe and well tolerated in Part 1 will be administered in Part 2. During the course of Part 2, each subject will participate in a screening phase, a baseline phase, a treatment phase and a follow up visit. There will be a total of up to 6 planned cohorts, each of which will consist of a different dose level, with 8 subjects per cohort. In each cohort, 6 subjects will receive a dose of CC 90001 and 2 subjects will receive placebo depending on the randomization schedule. It is planned for study drug to be administered once daily for up to 14 days. Proposed dose levels in Part 2 may be modified and/or eliminated based on data obtained from Part 1; however, the maximum dose administered in Part 2 will not exceed the maximum tolerated dose in Part 1.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	CC-90001	CC-90001 10mg will be administered as a single dose
DRUG	CC-90001	CC-90001 30mg will be administered as a single dose
DRUG	CC-90001	CC-90001 60mg will be administered as a single dose
DRUG	CC-90001	CC-90001 120mg will be administered as a single dose
DRUG	CC-90001	CC-90001 240mg will be administered as a single dose
DRUG	CC-90001	CC-90001 10mg will be administered daily for 14 days
DRUG	CC-90001	CC-90001 30mg will be administered daily for 14 days
DRUG	CC-90001	CC-90001 60mg will be administered daily for 14 days
DRUG	CC-90001	CC-90001 120mg will be administered daily for 14 days
DRUG	CC-90001	CC-90001 240mg will be administered daily for 14 days
DRUG	Placebo	Placebo will be administered once daily for up to 14 days depending on the Part of the study
DRUG	CC-90001	CC-90001 480mg will be administered as a single oral dose
DRUG	CC-90001	CC-90001 720mg will be administered as a single oral dose
DRUG	CC-90001	CC-90001 480mg will be administered daily for 14 days

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2014-04-10
• Last updated: 2014-10-15

Locations

1 site across 1 country: United States