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

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Idorsia Pharmaceuticals

Status and phase

Terminated
Phase 1

Conditions

Healthy Subjects

Treatments

Drug: Placebo
Drug: AC-084

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

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)
Treatment:
Drug: AC-084

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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