NCT04211545

Relative Bioavailability and PPI Effects of CC-92480 Test and Reference Formulations in Healthy Subjects

A Phase 1, Open-label Study to Assess the Single Dose Pharmacokinetics and Relative Bioavailability of a Test Capsule Formulation of CC-92480 Compared to a Reference CC 92480 Capsule Formulation and the Effect of a Proton Pump Inhibitor on the Pharmacokinetics of CC 92480 From Test and Reference Formulations in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, open-label, randomized, four-period, crossover study in healthy females of nonchildbearing potential and male subjects - to be conducted at a single center in the United States. The study will consist of a screening phase, a baseline phase, four treatment periods, and a follow-up phone call. The 4 treatment periods are divided into two pairs (Period 1 and 2 and Period 3 and 4), potentially separated by an intermission during which subjects will be discharged from the research unit: Periods 1 and 2 support relative bioavailability (RBA) estimation, while Periods 3 and 4 support estimation of PPI effects.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Rabeprazole	Rabeprazole
DRUG	CC-92480	CC-92480

Timeline

• Start date: 2019-10-21
• Primary completion: 2019-12-26
• Completion: 2019-12-26
• First posted: 2019-12-26
• Last updated: 2020-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study