A Study to Evaluate ACT-132577 in Healthy Male Subjects
- Registration Number
- NCT03100591
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 14C-radiolabelled ACT-132577 14C-radiolabeled 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
- Primary Outcome Measures
Name Time Method Cumulative excretion of radioactivity in urine and feces 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
- Secondary Outcome Measures
Name Time Method Maximum plasma concentration (Cmax) of 14C-radiolabeled ACT-132577 From study treatment administration up to day 15 Cmax is directly derived from the observed plasma concentrations of ACT-132577 and its metabolites
Area under the plasma concentration-time curve (AUC) ACT-132577 and its metabolites 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
Terminal half-life (t1/2) of 14C-radiolabeled ACT-132577 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
Area under the plasma concentration-time curve (AUC) of 14C-radiolabeled ACT-132577 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
Maximum plasma concentration (Cmax) of ACT-132577 and its metabolites From study treatment administration up to day 15 Cmax is directly derived from the observed plasma concentrations of ACT-132577 and its metabolites
Time to reach Cmax (tmax) of ACT-132577 and its metabolites From study treatment administration up to day 15 tmax is directly derived from the observed plasma concentrations of ACT-132577 and its metabolites
Terminal half-life (t1/2) of ACT-132577 and its metabolites 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
Number of subjects with treatment-emergent adverse events and serious adverse events From study treatment administration up to day 32 Collection of any adverse event at each dose level
Time to reach Cmax (tmax) of 14C-radiolabeled ACT-132577 From study treatment administration up to day 15 tmax is directly derived from the observed plasma concentrations of ACT-132577 and its metabolites
Trial Locations
- Locations (1)
PRA Health Sciences
🇳🇱Groningen, Netherlands