Healthy Subjects
Conditions
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
Interventions
DRUG14C-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
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 65 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 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 |
| 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 |
| 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 |
Countries
Netherlands
Outcome results
None listed