Clinical trial NCT03100591: A Study to Evaluate ACT-132577 in Healthy Male Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2017-04-04
Enrollment: 6
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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).

Primary outcomes:
measure: Cumulative excretion of radioactivity in urine and feces
timeFrame: From study treatment administration up to day 15
Secondary outcomes:
measure: Number of subjects with treatment-emergent adverse events and serious adverse events
timeFrame: From study treatment administration up to day 32
measure: Maximum plasma concentration (Cmax) of 14C-radiolabeled ACT-132577
timeFrame: From study treatment administration up to day 15
measure: Time to reach Cmax (tmax) of 14C-radiolabeled ACT-132577
timeFrame: From study treatment administration up to day 15
measure: Terminal half-life (t1/2) of 14C-radiolabeled ACT-132577
timeFrame: From study treatment administration up to day 15
measure: Area under the plasma concentration-time curve (AUC) of 14C-radiolabeled ACT-132577
timeFrame: From study treatment administration up to day 15
measure: Maximum plasma concentration (Cmax) of ACT-132577 and its metabolites
timeFrame: From study treatment administration up to day 15
measure: Time to reach Cmax (tmax) of ACT-132577 and its metabolites
timeFrame: From study treatment administration up to day 15
measure: Terminal half-life (t1/2) of ACT-132577 and its metabolites
timeFrame: From study treatment administration up to day 15
measure: Area under the plasma concentration-time curve (AUC) ACT-132577 and its metabolites
timeFrame: From study treatment administration up to day 15
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials
role: STUDY_DIRECTOR
References: