A Study to Evaluate ACT-132577 in Healthy Male Subjects

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

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-28

Study Completion Date

2017-04-18

Brief Summary

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The primary purpose of this study is to investigate the rate and routes (urine and feces) of elimination of ACT-132577, and the mass balance in urine and feces

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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14C-radiolabelled ACT-132577

On Day 1, subjects will receive a single oral dose of 25 mg 14C-radiolabeled ACT-132577, administered as an oral formulation in the fasted state

Group Type EXPERIMENTAL

14C-radiolabeled ACT-132577

Intervention Type DRUG

Single oral dose of 3.7 megabecquerel (MBq) (100 microcurie \[μCi\]) 14C-radiolabeled ACT-132577 administered as 1 capsule of 25 mg

Interventions

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14C-radiolabeled ACT-132577

Single oral dose of 3.7 megabecquerel (MBq) (100 microcurie \[μCi\]) 14C-radiolabeled ACT-132577 administered as 1 capsule of 25 mg

Intervention Type DRUG

Other Intervention Names

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Aprocitentan

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure;
* Healthy male subjects aged between 45 and 65 years (inclusive) at screening;
* Body mass index of 18.0 to 28.0 kg/m2 (inclusive) at screening;
* Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.

Exclusion Criteria

* Values of hepatic aminotransferase (alanine aminotransferase and/or aspartate aminotransferase) \> 3 × upper limit of normal range at screening;
* Hemoglobin \< 100 g/L at screening;
* Known hypersensitivity to ACT-132577 or drugs of the same class, or any excipient of the ACT-132577 drug formulation;
* Known hypersensitivity or allergy to natural rubber latex;
* Previous exposure to ACT-132577;
* Treatment with another investigational drug within 3 months prior to screening or participation in more than 4 investigational drug studies within 1 year prior to screening;
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol;
* A radiation burden of \> 0.1 milliSievert (mSv) and ≤ 1.0 mSv in the period of 1 year prior to screening; a radiation burden of ≥ 1.1 mSv and ≤ 2.0 mSv in the period of 2 years prior to screening, etc. (add 1 year per 1 mSv).

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes