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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02905253
• Other study ID #: AC-084-101
• Status: Terminated
• Phase: Phase 1
• Start date: September 12, 2016
• Est. completion date: December 10, 2017

Study information

• Verified date: July 2018
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: December 10, 2017
• Est. primary completion date: December 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• AC-084
Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg
• Placebo
Placebo capsules matching AC-084 capsules

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs) (Part A)	Treatment-emergent AEs and treatment-emergent serious AEs	From dosing until day 4
Primary	Number of participants with adverse events (AEs) (Part B)	Treatment-emergent AEs and treatment-emergent serious AEs	From dosing until day 8
Primary	Number of participants with adverse events (AEs) (Part C)	Treatment-emergent AEs and treatment-emergent serious AEs	From dosing until day 6
Primary	Incidence of safety events of interest (Part A)	Events of interest are any abnormalities in ECG, vital signs or laboratory test results	From dosing until day 4
Primary	Incidence of safety events of interest (Part B)	Events of interest are any abnormalities in ECG, vital signs or laboratory test results	From dosing until day 8
Primary	Incidence of safety events of interest (Part C)	Events of interest are any abnormalities in ECG, vital signs or laboratory test results	From dosing until day 6
Secondary	Maximum plasma concentration (Cmax) following single oral ascending doses (Part A)	Cmax is derived from the observed plasma concentration-time curves	From dosing until day 4
Secondary	Maximum plasma concentration (Cmax) following single oral ascending doses (Part B)	Cmax is derived from the observed plasma concentration-time curves	From dosing until day 8
Secondary	Maximum plasma concentration (Cmax) following single oral ascending doses (Part C)	Cmax is derived from the observed plasma concentration-time curves	From dosing until day 6
Secondary	Time to reach Cmax (tmax) following single oral ascending doses (Part A)	Tmax is derived from the observed plasma concentration-time curves	From dosing until day 4
Secondary	Time to reach Cmax (tmax) following single oral ascending doses (Part B)	Tmax is derived from the observed plasma concentration-time curves	From dosing until day 8
Secondary	Time to reach Cmax (tmax) following single oral ascending doses (Part C)	Tmax is derived from the observed plasma concentration-time curves	From dosing until day 6
Secondary	Terminal half-life [t(1/2)] following single oral ascending doses (Part A)		From dosing until day 4
Secondary	Terminal half-life [t(1/2)] following single oral ascending doses (Part B)		From dosing until day 8
Secondary	Terminal half-life [t(1/2)] following single oral ascending doses (Part C)		From dosing until day 6
Secondary	Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part A)	AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification and from zero to infinity	From dosing until day 4
Secondary	Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part B)	AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification and from zero to infinity	From dosing until day 8
Secondary	Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part C)	AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification and from zero to infinity	From dosing until day 6