NCT02802735

Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Apremilast in Healthy Adult Male Korean Subjects

A Phase 1, Open-label, Two Part Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Apremilast in Healthy Adult Male Korean Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Amgen · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This two-part study was designed to evaluate the pharmacokinetics (PK) of single and multiple doses of apremilast in healthy adult Korean males.

Detailed description

The study will consist of two parts. Part 1 will evaluate the PK of ascending single doses of apremilast. Part 2 will evaluate the PK of apremilast when administered as multiple doses over 14 days.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Apremilast	Tablet for oral administration
DRUG	Placebo	Tablet for oral administration

Timeline

• Start date: 2016-06-22
• Primary completion: 2016-08-05
• Completion: 2016-08-05
• First posted: 2016-06-16
• Last updated: 2021-07-06
• Results posted: 2021-07-06

Locations

1 site across 1 country: South Korea