drugset / Trial / NCT04839809

A Study to Assess Safety, Tolerability, and Pharmacokinetics of CC-92480 Formulations in Healthy Adult Participants

NCT04839809

Phase 1 Completed 40 enrolled Celgene Corporation
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase 1 study that will be conducted in 2 parts. Participants may participate in 1 part only. * Part 1 will be a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and PK of CC-92480-02 (Formulation A) administered orally under fasted conditions in healthy adult participants. * Part 2 will be a randomized, open-label, 2 × 4 crossover study (Periods 1, 2, 3, and 4) to evaluate the relative bioavailability (RBA) of Formulation A versus Formulation B under fasted conditions and explore safety, tolerability, and PK effects of food on Formulation A and Formulation B in healthy adult participants.

Timeline

Start
2021-01-19
Primary completion
2021-10-08
Completion
2021-10-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Mezigdomide Small molecule Oral

Indications

No indication recorded.