NCT03803644

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single Ascending Doses of CC-92480 in Healthy Subjects

A Phase 1, Two-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dosing of CC-92480 and to Explore the Effect of Food on the Bioavailability of CC-92480 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a two-part study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CC-92480 and explore the effect of food on the bioavailability of CC-92480 in healthy subjects. Part 1: Part 1 is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of CC-92480 following administration of single oral doses in healthy adult subjects. Part 1 will consist of escalating single doses in sequential groups. Approximately 40 subjects will be enrolled into 5 planned dose level cohorts. Each dose level cohort will consist of 8 subjects; 6 subjects will receive CC-92480 and 2 subjects will receive placebo according to the randomization schedule. Part 2 Part 2 is a single-center, open-label, randomized, 2-period, 2-way crossover study to explore the effect of food (Food and Drug Administration \[FDA\] standard high-fat breakfast) on the single-dose PK of CC-92480 in healthy adult subjects.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	CC-92480	Part 1 dose escalation
DRUG	CC-92480	CC-92480

Timeline

• Start date: 2018-12-21
• Primary completion: 2019-05-28
• Completion: 2019-05-28
• First posted: 2019-01-14
• Last updated: 2020-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study