NCT02652936

A Pharmacokinetics Study of AF-130 in Healthy Subjects

A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of AF-130 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a 2-part, single centre, single (Part 1) and multiple (Part 2) dose escalation study in healthy male subjects.

Detailed description

Part 1 is a double-blind, placebo-controlled, randomised single dose design in up to 64 healthy male subjects. Part 1 will consist of Groups 1 to 6, each comprising 8 subjects (total of 48 subjects). There will be an option to enrol 2 additional groups (8 subjects in each of Groups 7 and 8) to assess alternative dose levels. Subjects will be randomised to receive active or placebo in the fasted state. Part 2 is a double-blind, placebo-controlled, randomised, multiple ascending dose design in up to 45 healthy male subjects. Part 2 will consist of Groups 9 to 11, each comprising 9 subjects (total of 27 subjects). There will be an option to enrol 2 additional groups (9 subjects in each of Groups 12 and 13) to assess alternative multiple dose levels. Part 2 will not commence before completion of Groups 1 to 3 in Part 1. Subjects will be randomised to receive active or placebo in the fasted state. The planned dosing regimen is once per day however, this may be modified to twice per day depending on emerging pharmacokinetic data from Part 1.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	AF-130	AF-130 oral capsules (50 mg) administered as a single dose or once daily for 7 days
DRUG	Placebo comparator	AF-130 matching placebo capsule

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2016-01-12
• Last updated: 2016-12-06

Locations

1 site across 1 country: United Kingdom