A Pharmacokinetics Study of AF-130 in Healthy Subjects

Healthy Volunteers Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT02652936
• Study type: Interventional
• Source: Afferent Pharmaceuticals, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: October 2015
• Completion date: March 2016