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.

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. - ACT-132577 Human ADME Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45381

Enrollment

Registered

2017-03-07

Start date

2017-03-08

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypertension PAH

Interventions

The volunteer will receive a single dose of 25 mg/3.7 MBq radiolabeled ACT-132577 as an oral capsule.

ACT-1352577

ADME

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Healthy male volunteers - 45-65 years, inclusive - BMI: 18.0-28.0 kg / m2, inclusive - SBP: 100-145 mmHg - DBP: 50-90 mmHg - HR: 45-90 bpm

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. 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. Loss of 250 mL or more of blood within 3 months prior to screening. 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
- Clinically relevant change from baseline to each time point of measurement in vital signs (supine blood pressure and pulse rate) after study treatment administration. - Clinically relevant change from baseline to each time point of measurement in ECG variables: HR, and the intervals: PR, QRS, QT, RR, QTcB, and QTcF after study treatment administration. - Clinically relevant change from baseline to EOS in clinical laboratory tests (clinical chemistry and hematology). - Clinically relevant treatment-emergent ECG abnormalities from the study treatment administration up to EOS. - Treatment-emergent AEs from the study treatment administration up to EOS. - Treatment-emergent SAEs from the study treatment administration up to EOS. - Mass balance (Cumulative excretion of radioactivity in urine and feces.) - PK of 14C-radioactivity in whole blood and plasma - PK of ACT-132577 and its metabolites in plasma - Metabolic profiling (Profiles, identification, and quantification of metabolites in plasma, urine, and feces.)	—

Measure

Time frame

- Clinically relevant change from baseline to each time point of measurement in vital signs (supine blood pressure and pulse rate) after study treatment administration. - Clinically relevant change from baseline to each time point of measurement in ECG variables: HR, and the intervals: PR, QRS, QT, RR, QTcB, and QTcF after study treatment administration. - Clinically relevant change from baseline to EOS in clinical laboratory tests (clinical chemistry and hematology). - Clinically relevant treatment-emergent ECG abnormalities from the study treatment administration up to EOS. - Treatment-emergent AEs from the study treatment administration up to EOS. - Treatment-emergent SAEs from the study treatment administration up to EOS. - Mass balance (Cumulative excretion of radioactivity in urine and feces.) - PK of 14C-radioactivity in whole blood and plasma - PK of ACT-132577 and its metabolites in plasma - Metabolic profiling (Profiles, identification, and quantification of metabolites in plasma, urine, and feces.)

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)