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

NCT ID: NCT02905253

Last Updated: 2018-07-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-12
• Study Completion Date: 2017-12-10

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

AC-084, single ascending dose (Part A)

AC-084 administered at different single dose levels in a sequential manner, and in a maximum of 7 dose levels starting from 1 mg (number of cohorts and dose levels will depend on the safety and pharmacokinetic results of the previous cohort). Each dose level will be investigated in a new group of at least 8 healthy male subjects (6 on active drug and 2 on placebo)

Group Type: EXPERIMENTAL

AC-084

Intervention Type: DRUG

Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg

Placebo,single ascending dose (Part A)

Matched placebo administered as single ascending doses in parallel to AC-084

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo capsules matching AC-084 capsules

AC-084, multiple ascending dose (Part B)

AC-084 administered in a twice daily (b.i.d.) dosing regimen at multiple dose levels. The starting dose will be between 1 and 30 mg and will be selected on the basis of the safety and pharmacokinetic results of the part A. Each dose level will be investigated in a new group of at least 8 healthy male subjects (6 on active drug and 2 on placebo)

Group Type: EXPERIMENTAL

AC-084

Intervention Type: DRUG

Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg

Placebo,multiple ascending dose (Part B)

Matched placebo administered as multiple ascending doses in parallel to AC-084

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo capsules matching AC-084 capsules

AC-084, single dose (Part C)

Up to 6 subjects in part C will receive AC-084 administered at a single dose (foreseen to be 100 mg)

Group Type: EXPERIMENTAL

AC-084

Intervention Type: DRUG

Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg

Interventions

AC-084

Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg

Intervention Type: DRUG

Placebo

Placebo capsules matching AC-084 capsules

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed informed consent in the local language prior to any study-mandated procedure
• Healthy male subjects for Part A, healthy male and female subjects for Part B and Part C aged between 18 and 55 years (inclusive) at screening
• No clinically significant findings on physical examination at screening
• Body mass index (BMI) of 18.0 to 28.0 kg/m2 (inclusive) at screening
• CYP2C9 poor metabolizers (Part C)

Exclusion Criteria

• History or clinical evidence of any disease and/or existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed)
• Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions
• Treatment or substances known to induce CYP enzyme drug metabolism within 30 days prior to first study treatment administration
• Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
• Known allergic reactions or hypersensitivity to the study treatment or drugs of the same class, or any of their excipients
• For Part A and Part B, CYP2C9 poor metabolizers enrolled in a cohort to be dosed with single or multiple dose of 500 mg or higher of ACT-774312 (confirmed by genotyping before enrollment)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martine Géhin, PhD

Role: STUDY_DIRECTOR

Actelion

Locations

Covance Clinical Research Unit

Leeds, , United Kingdom

Countries

United Kingdom

Other Identifiers

AC-084-101

Identifier Type: -

Identifier Source: org_study_id