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

Phase 1TerminatedNCT02905253

Idorsia Pharmaceuticals Ltd.56 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Healthy Subjects

Interventions

AC-084DRUG

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

PlaceboDRUG

Placebo capsules matching AC-084 capsules

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Covance Clinical Research Unit

Leeds, United Kingdom

Outcomes

Primary Outcomes

Number of participants with adverse events (AEs) (Part A)

Treatment-emergent AEs and treatment-emergent serious AEs

Time frame: From dosing until day 4

Number of participants with adverse events (AEs) (Part B)

Treatment-emergent AEs and treatment-emergent serious AEs

Time frame: From dosing until day 8

Number of participants with adverse events (AEs) (Part C)

Treatment-emergent AEs and treatment-emergent serious AEs

Time frame: From dosing until day 6

Incidence of safety events of interest (Part A)

Events of interest are any abnormalities in ECG, vital signs or laboratory test results

Time frame: From dosing until day 4

Incidence of safety events of interest (Part B)

Events of interest are any abnormalities in ECG, vital signs or laboratory test results

Time frame: From dosing until day 8

Incidence of safety events of interest (Part C)

Events of interest are any abnormalities in ECG, vital signs or laboratory test results

Time frame: From dosing until day 6

Secondary Outcomes

Maximum plasma concentration (Cmax) following single oral ascending doses (Part A)

Cmax is derived from the observed plasma concentration-time curves

Time frame: From dosing until day 4

Maximum plasma concentration (Cmax) following single oral ascending doses (Part B)

Data from ClinicalTrials.gov

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