A Study to Evaluate if ID-085 is Safe, Its Fate in the Body as Well as Its Potential Effects on the Body in Healthy Subjects

Idorsia Pharmaceuticals Ltd.88 enrolled

Overview

The objective of this study is to evaluate the tolerability, safety, and pharmacokinetic of single- and multiple-ascending doses of ID-085 in healthy subjects.

The study is designed in two parts, A and B. Part A: single-center, double-blind, randomized, placebo-controlled, single ascending dose. Part B: single-center, double-blind, randomized, placebo-controlled, multiple ascending dose.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Subjects

Interventions

ID-085DRUG

Hard gelatin capsules for oral administration formulated in strengths of 10 mg, 100 mg, and 200 mg

Placebo oral capsuleDRUG

Placebo capsules matching ID-085 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 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 30.0 kg/m2 (inclusive) at screening. 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. * Pregnant or lactating women. * Known allergic reactions or hypersensitivity to the study treatment or drugs of the same class, or any of the excipients. * Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Locations (1)

Covance Clinical Research Unit - Clinical Pharmacology Services

Leeds, United Kingdom