Single-center, open-label study with 14C-radiolabeled ACT-246475 to investigate its mass balance, pharmacokinetics, and metabolism following single subcutaneous administration to healthy male subjects.

Single-center, open-label study with 14C-radiolabeled ACT-246475 to investigate its mass balance, pharmacokinetics, and metabolism following single subcutaneous administration to healthy male subjects. - ACT-246475 ADME study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46067

Enrollment

Registered

2018-06-21

Start date

2018-07-06

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Acute myocardial infarction (heart attack)

Interventions

The volunteer will receive a single dose of 16 mg/3.7 MBq radiolabeled ACT-246475 as an injection of 1 milliliter under the skin (subcutaneous) in the upper leg. The volunteer must remain in a sitti

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Healthy male subjects -45-65 yrs, inclusive at screening -BMI: 18.0-28.0 kg/m2 (inclusive) at screening. -Non-smoking

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
•To investigate the rate and routes of elimination of ACT-246475 and its mass balance in urine and feces. •To investigate the PK of total 14C-radioactivity in whole blood and plasma. •To investigate the PK of ACT-246475 in plasma. •To identify and quantify the metabolites of ACT-246475 in plasma, urine, and feces. •To evaluate the safety and tolerability of 16 mg ACT-246475 including 3.7 MBq (100 µCi) 14C-radiolabeled ACT-246475 in healthy male subjects.	—

Measure

Time frame

•To investigate the rate and routes of elimination of ACT-246475 and its mass balance in urine and feces. •To investigate the PK of total 14C-radioactivity in whole blood and plasma. •To investigate the PK of ACT-246475 in plasma. •To identify and quantify the metabolites of ACT-246475 in plasma, urine, and feces. •To evaluate the safety and tolerability of 16 mg ACT-246475 including 3.7 MBq (100 µCi) 14C-radiolabeled ACT-246475 in healthy male subjects.

—

Secondary

Measure	Time frame
n/a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)