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

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Placebo oral capsule; Drug: ID-085

Study type: Interventional

Funder types: Industry

Identifiers

NCT03372629

ID-085-101

2017-004124-30 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 88 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 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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88 participants in 4 patient groups, including a placebo group

ID-085, single ascending dose (Part A)

Experimental group

Description:

ID-085 administered at different single dose levels in a sequential manner, and in a maximum of 6 dose levels starting from 10 mg (number of cohorts and dose levels will depend on the safety and pharmacokinetic results of the previous cohort)

Treatment:

Drug: ID-085

Placebo, single ascending dose (Part A)

Placebo Comparator group

Description:

Matched placebo administered as single ascending doses in parallel to ID-085

Treatment:

Drug: Placebo oral capsule

ID-085 multiple ascending dose (Part B)

Experimental group

Description:

ID-085 administered in a twice daily (b.i.d.) dosing regimen at multiple dose levels. The starting dose will be either 10 or 30 mg and will be selected on the basis of the safety and pharmacokinetic results of the part A

Treatment:

Drug: ID-085

Placebo, multiple ascending dose (Part B)

Placebo Comparator group

Description:

Matched placebo administered as single ascending doses in parallel to ID-085

Treatment:

Drug: Placebo oral capsule