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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

NCT ID: NCT03372629

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-12

Study Completion Date

2018-12-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ID-085, single ascending dose (Part A)

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)

Group Type EXPERIMENTAL

ID-085

Intervention Type DRUG

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

Placebo, single ascending dose (Part A)

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

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Placebo capsules matching ID-085 capsules

ID-085 multiple ascending dose (Part B)

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

Group Type EXPERIMENTAL

ID-085

Intervention Type DRUG

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

Placebo, multiple ascending dose (Part B)

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

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Placebo capsules matching ID-085 capsules

Interventions

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ID-085

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

Intervention Type DRUG

Placebo oral capsule

Placebo capsules matching ID-085 capsules

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Idorsia Pharmaceuticals Ltd.

Locations

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Covance Clinical Research Unit - Clinical Pharmacology Services

Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2017-004124-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ID-085-101

Identifier Type: -

Identifier Source: org_study_id