NCT02905253

A Study to Evaluate if AC-084 is Safe, Its Fate in the Body as Well as Its Potential Effects on the Body in Healthy Subjects

A Three-part Single-center, Phase 1 Study to Assess the Tolerability, Safety, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of Ascending Single and Multiple Doses of AC-084 in Healthy Subjects and to Investigate the Pharmacokinetics of a Single Dose of AC-084 in Healthy CYP2C9 Poor Metabolizers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this first-in-man study is to investigate whether AC-084 is safe and well-tolerated when orally administered at single- and multiple-ascending dose to healthy adults

Detailed description

The study is designed in three parts, A, B and C Part A: single-center, double-blind, randomized, placebo-controlled, single ascending dose Part B: single-center, double-blind, randomized, placebo-controlled, multiple ascending dose Part C: single-center, open-label, single dose in CYP2C9 poor metabolizers

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	AC-084	Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg
DRUG	Placebo	Placebo capsules matching AC-084 capsules

Timeline

• Start date: 2016-09-12
• Primary completion: 2017-12-10
• Completion: 2017-12-10
• First posted: 2016-09-19
• Last updated: 2018-07-10

Locations

1 site across 1 country: United Kingdom