A Study to Evaluate ACT-132577 in Healthy Male Subjects

NCT03100591 | Completed Phase 1

• 1 other identifier: AC-080-104
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Cumulative excretion of radioactivity in urine and feces

  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 Outcomes (9)

• Number of subjects with treatment-emergent adverse events and serious adverse events

  From study treatment administration up to day 32

• Maximum plasma concentration (Cmax) of 14C-radiolabeled ACT-132577

  From study treatment administration up to day 15

• Time to reach Cmax (tmax) of 14C-radiolabeled ACT-132577

  From study treatment administration up to day 15

• Terminal half-life (t1/2) of 14C-radiolabeled ACT-132577

  From study treatment administration up to day 15

• Area under the plasma concentration-time curve (AUC) of 14C-radiolabeled ACT-132577

  From study treatment administration up to day 15

Study Arms (1)

14C-radiolabelled ACT-132577

EXPERIMENTAL

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

Interventions

14C-radiolabeled ACT-132577 DRUG

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

Also known as: Aprocitentan

14C-radiolabelled ACT-132577

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (1)

PRA Health Sciences

Groningen, Netherlands

Location

MeSH Terms

Interventions

aprocitentan

Study Officials

• Clinical Trials

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 4, 2017
• Study Start: March 28, 2017
• Primary Completion: April 18, 2017
• Study Completion: April 18, 2017
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

NL (1)