NCT02034773

3-part Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of Multiple Doses of CC-220 and Relative Bioavailability of a Formulated CC-220 Capsule

A Phase 1, Three-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of CC-220 and to Evaluate the Relative Bioavailability of a Formulated CC-220 Capsule in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Celgene Corporation · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of CC-220 in healthy subjects and to evaluate the relative bioavailability of a formulated CC-220 capsule

Detailed description

This is a 3-part study to be conducted at a single study center. Part 1 is a randomized, double-blind, placebo-controlled, ascending-dose study. 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 4 cohorts, each of which consists of a different dose level and/or dosing duration, with 8 or 9 subjects per cohort. In each cohort, 6 subjects will receive a dose of CC-220 and the remaining subjects will receive placebo depending on the randomization schedule. In 2 of the cohorts, study drug will be administered once daily for a total of 14 days. In the other 2 cohorts, study drug will be administered once daily for 28 days. In one of the 28-day dosing cohorts, 2 vaccinations (tetanus toxoid adsorbed and pneumococcal vaccinations) will also be administered on Day 14 of the 28-day dosing period to help characterize the effect of CC-220 on antibody responses. Part 2 is a randomized, double-blind, placebo-controlled, parallel-group study to explore the effects of an alternative dosing schedule on the pharmacodynamics of CC-220. 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 2 cohorts, each of which consists of a different dose level, with 9 subjects per cohort. In each cohort, 6 subjects will receive a dose of CC-220 and 3 subjects will receive placebo depending on the randomization schedule. The dosing frequency will be either once every 3 days for 14 days or once every 7 days for 28 days. Part 3 is a randomized, open-label, two-period, two-way crossover study to evaluate the relative bioavailability of one CC-220 formulated capsule, relative to two reference capsules, following a single oral dose of CC-220. During the course of Part 3, each subject will participate in a screening phase, a baseline phase, a treatment phase consisting of 2 periods, and a follow up visit. There will be one cohort consisting of a total of 12 subjects. In each study period, approximately 6 subjects will receive a single dose of CC-220 as one formulated capsule (test product) and approximately 6 subjects will receive a single dose of CC-220 as two reference capsules (reference product).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	CC-220	CC-220 0.3mg will be administered once daily for 14 days
DRUG	CC-220	CC-220 1mg will be administered once daily for 28 days + 1 dose of tetanus toxoid vaccination and 1 dose of pneumococcal vaccination
DRUG	CC-220	CC-220 0.3mg will be administered once daily for 28 days
DRUG	CC-220	CC-220 1mg will be administered once daily for 7 days on 2 separate occasions, with a 7-day washout in between, for a total of 14 days of dosing
DRUG	Placebo	Placebo will be administered once daily for up to 28 days
DRUG	CC-220	CC-220 0.3mg will be administered every 3 days for 14 days (5 total doses)
DRUG	CC-220	CC-220 1mg (once every 7 days for 28 days)
DRUG	CC-220	CC-220 1mg will be administered as a single dose in each of 2 study periods; once as a formulated capsule and once as two reference capsules

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2014-01-13
• Last updated: 2014-01-13

Locations

1 site across 1 country: United States