A Study to Evaluate ACT-132577 in Healthy Male Subjects

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03100591
• Other study ID #: AC-080-104
• Status: Completed
• Phase: Phase 1
• Start date: March 28, 2017
• Est. completion date: April 18, 2017

Study information

• Verified date: November 2022
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 18, 2017
• Est. primary completion date: April 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of subjects with treatment-emergent adverse events and serious adverse events	Collection of any adverse event at each dose level	From study treatment administration up to day 32
Secondary	Maximum plasma concentration (Cmax) of 14C-radiolabeled ACT-132577	Cmax is directly derived from the observed plasma concentrations of ACT-132577 and its metabolites	From study treatment administration up to day 15
Secondary	Time to reach Cmax (tmax) of 14C-radiolabeled ACT-132577	tmax is directly derived from the observed plasma concentrations of ACT-132577 and its metabolites	From study treatment administration up to day 15
Secondary	Terminal half-life (t1/2) of 14C-radiolabeled ACT-132577	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
Secondary	Area under the plasma concentration-time curve (AUC) of 14C-radiolabeled ACT-132577	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
Secondary	Maximum plasma concentration (Cmax) of ACT-132577 and its metabolites	Cmax is directly derived from the observed plasma concentrations of ACT-132577 and its metabolites	From study treatment administration up to day 15
Secondary	Time to reach Cmax (tmax) of ACT-132577 and its metabolites	tmax is directly derived from the observed plasma concentrations of ACT-132577 and its metabolites	From study treatment administration up to day 15
Secondary	Terminal half-life (t1/2) of ACT-132577 and its metabolites	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
Secondary	Area under the plasma concentration-time curve (AUC) ACT-132577 and its metabolites	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