A Study to Evaluate ACT-132577 in Healthy Male Subjects

November 22, 2022 updated by: Idorsia Pharmaceuticals Ltd.

Single-center, Open-label Study With 14C-radiolabeled ACT-132577 to Investigate the Mass Balance, Pharmacokinetics, and Metabolism Following Single Oral Administration to Healthy Male Subjects

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands
        • PRA Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Drug: 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
Other Names:
  • Aprocitentan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cumulative excretion of radioactivity in urine and feces
Time Frame: From study treatment administration up to day 15
14C-radioactivity will be measured daily in urine and feces samples for determination of total radioactivity recovery
From study treatment administration up to day 15

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of subjects with treatment-emergent adverse events and serious adverse events
Time Frame: From study treatment administration up to day 32
Collection of any adverse event at each dose level
From study treatment administration up to day 32
Maximum plasma concentration (Cmax) of 14C-radiolabeled ACT-132577
Time Frame: From study treatment administration up to day 15
Cmax is directly derived from the observed plasma concentrations of ACT-132577 and its metabolites
From study treatment administration up to day 15
Time to reach Cmax (tmax) of 14C-radiolabeled ACT-132577
Time Frame: From study treatment administration up to day 15
tmax is directly derived from the observed plasma concentrations of ACT-132577 and its metabolites
From study treatment administration up to day 15
Terminal half-life (t1/2) of 14C-radiolabeled ACT-132577
Time Frame: From study treatment administration up to day 15
t1/2 is calculated from the terminal rate constant obtained from the plasma concentrations-time curves of ACT-132577 and its metabolites
From study treatment administration up to day 15
Area under the plasma concentration-time curve (AUC) of 14C-radiolabeled ACT-132577
Time Frame: From study treatment administration up to day 15
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 study treatment administration up to day 15
Maximum plasma concentration (Cmax) of ACT-132577 and its metabolites
Time Frame: From study treatment administration up to day 15
Cmax is directly derived from the observed plasma concentrations of ACT-132577 and its metabolites
From study treatment administration up to day 15
Time to reach Cmax (tmax) of ACT-132577 and its metabolites
Time Frame: From study treatment administration up to day 15
tmax is directly derived from the observed plasma concentrations of ACT-132577 and its metabolites
From study treatment administration up to day 15
Terminal half-life (t1/2) of ACT-132577 and its metabolites
Time Frame: From study treatment administration up to day 15
t1/2 is calculated from the terminal rate constant obtained from the plasma concentrations-time curves of ACT-132577 and its metabolites
From study treatment administration up to day 15
Area under the plasma concentration-time curve (AUC) ACT-132577 and its metabolites
Time Frame: From study treatment administration up to day 15
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 study treatment administration up to day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Idorsia Pharmaceuticals Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 18, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 18, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AC-080-104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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