Conditions: Healthy Volunteer
Keywords: Apremilast pharmacokinetic safety Pharmacokinetics and safety in healthy volunteer subjects
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 36
Healthy volunteers: yes

Brief summary:
The purpose of the study is to evaluate the effects of age and sex on the pharmacokinetics and safety of a single oral dose of 30 mg apremilast in healthy adults.

Detailed description:
This is an open-label, parallel group study where eligible elderly adults (aged 65-85 years inclusive) and younger adults (aged 18-55 years inclusive) and who are matched to the elderly participants by sex and body mass index (BMI) (± 10%) will receive a single dose of 30 mg apremilast under fasting conditions.

Arms:
arm 1: Participants aged 65 to 85 years received a single oral dose of 30 mg apremilast on Day 1. arm 2: Participants aged 18 to 55 years received a single oral dose of 30 mg apremilast on Day 1.

Interventions: intervention 1: Apremilast
Intervention descriptions: intervention 1: One oral 30 mg dose of apremilast

Protocol document: