NCT04139226

A Study to Evaluate the Safety, Tolerability Pharmacokinetics, and Pharmacodynamics of a New Spray Dried Dispersion (SDD) Formulation of CC-11050 After Single Dose of CC-11050 and to Evaluate the Pharmacokinetics of CC-11050 Under Fasted and Fed Conditions and After Coadministration With Omeprazole

A Phase 1, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CC-11050 After Single and Multiple Doses of CC-11050 and Evaluate CC-11050 Pharmacokinetics Under Fasted and Fed Conditions and After Administration of CC-11050 Alone Compared to Co-administration With a Proton Pump Inhibitor in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a two-part study to be conducted at single study center, (additional center(s) may be selected if needed) to assess the safety, tolerability, PK and PD parameters for a new SDD formulation of CC-11050 in healthy subjects. The effects of a high-fat meal and omeprazole will also be assessed. Blood samples will be collected at prespecified times for PK, clinical laboratory safety assessments, PD (Part 1 only), and/or exploratory analyses. Safety will be monitored throughout the study from the time the ICF is signed through study completion.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	CC-11050	CC-11050

Timeline

• Start date: 2019-08-28
• Primary completion: 2020-02-27
• Completion: 2020-02-27
• First posted: 2019-10-25
• Last updated: 2020-06-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study