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

Idorsia Pharmaceuticals

Status and phase

Terminated

Phase 1

Conditions

Healthy Subjects

Treatments

Drug: AC-084

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02905253

AC-084-101

Details and patient eligibility

About

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

Full 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

Enrollment

56 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

56 participants in 5 patient groups, including a placebo group

AC-084, single ascending dose (Part A)

Experimental group

Description:

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)

Treatment:

Drug: AC-084

Placebo,single ascending dose (Part A)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

AC-084, multiple ascending dose (Part B)

Experimental group

Description:

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)

Treatment:

Drug: AC-084

Placebo,multiple ascending dose (Part B)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

AC-084, single dose (Part C)

Experimental group

Description:

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