NCT02521714

Study to Evaluatethe Bioavailability and Food Effect Lenalidomide as an Oral Suspension

A Phase 1, Open-label, Randomized, Three-period, Two-way Crossover Study in Healthy Subjects to Evaluate the Bioavailability of a Test Lenalidomide Oral Suspension Relative to the Reference Capsule Formulation and to Assess the Effect of Food on the Bioavailability of Lenalidomide From the Oral Suspension

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the amount of drug that reaches the circulation when a subject takes the test (liquid) formulation compared to the reference (capsule) formulation. The study will also examine the effect of a high fat meal on the levels of drug in blood.

Detailed description

This is a phase 1, open-label, randomized, three-period, two-way crossover study in healthy subjects. The study will consist of a screening phase, a baseline phase, three treatment periods, and a follow-up phone call. Each period will be two days in duration (Day 1 through Day 2) for dosing and sample collection. There will be a minimum of four days washout between doses. Within no more than 21 days (Day -21) and no less than two days (Day -2) prior to the start of Period 1, subjects will undergo routine screening procedures including physical examination (PE), 12-lead electrocardiogram (ECG), vital signs, clinical laboratory safety tests (serum chemistry, hematology, and urinalysis), serology screen, and drug/alcohol screen. Eligible subjects will be admitted into the study center on Day -1 of Period 1 for baseline assessments. During each period, subjects will receive a single 25 mg oral dose of lenalidomide on Day 1 according to the assigned treatment sequence. Serial blood sampling for the determination of lenalidomide concentrations in plasma will be performed for 24 hours post dose, and safety will be evaluated. Subjects will be domiciled at the study center from Day 1 of Period 1 through Day 2 of Period 3, including the 4 day washout between each dose of IP. All subjects will be discharged from the study center on Day 2 of Period 3 following completion of required study procedures. A follow-up phone call will occur approximately four days (±2 days) after discharge from the study center. The study will be conducted in compliance with International Conference on Harmonisation (ICH) Good Clinical Practices (GCPs).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Lenalidomide

Timeline

• Start date: 2015-08-14
• Primary completion: 2015-09-23
• Completion: 2015-09-23
• First posted: 2015-08-13
• Last updated: 2019-11-08

Locations

1 site across 1 country: United States