NCT02777554

A Study to Evaluate the Pharmacokinetic Exposure of 2 Formulations of Apremilast in Healthy Adults

A Phase 1, Open Label, Randomized, Two Part Study to Evaluate the Pharmacokinetic Exposure of a Once-Daily (QD) Apremilast Formulation Relative to the Twice-Daily (BID) Reference Immediate Release (IR) Tablet and the Effect of Food on the QD Apremilast Formulation in Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the relative bioavailability of apremilast once-daily formulation relative to a twice daily formulation when administered as multiple doses (Part 1), and when administered as a single dose under fasting and fed conditions (Part 2). Information on safety and tolerability will also be obtained.

Detailed description

Part 1: This is an open-label, randomized, two-period, two-sequence, crossover study in healthy subjects. The study will consist of a screening phase, a baseline phase, two treatment periods, and a follow-up phone call. Each period will be ten days in duration including 7 days of dosing and sample collection for up to 72 hours post Day 7 morning dose. There will be a washout between period 1 and period 2. Part 2: This is an open-label, randomized, four-period, four-sequence crossover study to evaluate the PK and exposure of apremilast following single dose administration of different formulations of apremilast. Part 2 will consist of a screening phase, baseline, four treatment periods, and a follow-up phone call. Each period will be four days in duration for dosing (Day 1) and sample collection for up to 72 hours post Day 1.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Apremilast IR	Apremilast immediate release tablet
DRUG	Apremilast XL	Apremilast extended release formulation tablet

Timeline

• Start date: 2016-08-17
• Primary completion: 2016-11-22
• Completion: 2016-11-22
• First posted: 2016-05-19
• Last updated: 2021-07-22
• Results posted: 2021-07-22

Locations

2 sites across 1 country: United States