NCT02236988

Study to Evaluate Pharmacokinetics of Prototype Modified-Release Formulations Of Apremilast in Healthy Men

A Phase 1, Open-Label, Single Center Study to Evaluate the Pharmacokinetics of Prototype Modified-Release Formulations Of Apremilast (CC-10004) in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Amgen · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will assess up to 12 different oral formulations of apremilast to determine how much apremilast is absorbed by the body compared to a reference formulation.

Detailed description

This will be a single-center, open-label, crossover, single modified-release-dose study in adult males to evaluate the pharmacokinetics (PK) of prototype modified-release (MR) formulations compared to the reference immediate-release (IR) apremilast formulation. Within 4 separate groups, participants will be randomly assigned to a treatment sequence. A total of up to 12 test MR formulations may be evaluated. Group 1: A 4-sequence, 4-period design to compare three modified-release prototypes with the reference immediate-release formulation. A total of 16 participants will be enrolled to obtain at least 12 participants who complete all 4 periods. Group 2: A 4-sequence, 4-period design to compare three MR prototypes with the reference IR formulation. Sixteen participants will be enrolled to obtain at least 12 participants who complete all four periods. Group 3: A six-sequence, three-period design to compare two MR prototypes with the reference IR formulation. Eighteen participants will be enrolled to obtain at least 12 participants who complete all three periods. Group 4: A 10-sequence, 5-period design to compare four MR prototypes with the reference IR formulation. Thirty participants will be enrolled to obtain at least 20 participants who complete all five periods.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Apremilast Immediate Release	30 mg immediate release tablets
DRUG	Apremilast Modified Release 1	75 mg oral tablet of prototype modified release (MR) 1
DRUG	Apremilast Modified Release 2	75 mg oral tablet of prototype MR 2
DRUG	Apremilast Modified Release 3	75 mg oral capsule of prototype MR 3
DRUG	Apremilast Modified Release 4	75 mg oral capsule of prototype MR 4
DRUG	Apremilast Modified Release 5	75 mg oral capsule of prototype MR 5
DRUG	Apremilast Modified Release 6	75 mg oral capsule of prototype MR 6
DRUG	Apremilast Modified Release 8	80 mg oral capsule of prototype MR 8
DRUG	Apremilast Modified Release 9	80 mg oral capsule of prototype MR 9
DRUG	Apremilast Modified Release 11	80 mg oral capsule of prototype MR 11
DRUG	Apremilast Modified Release 12	80 mg oral capsule of prototype MR 12
DRUG	Apremilast Modified Release 13	80 mg oral capsule of prototype MR 13
DRUG	Apremilast Modified Release 14	80 mg oral capsule of prototype MR 14

Timeline

• Start date: 2014-01-07
• Primary completion: 2014-09-11
• Completion: 2014-09-11
• First posted: 2014-09-11
• Last updated: 2021-06-01
• Results posted: 2021-06-01

Locations

1 site across 1 country: United States