Excretion balance, pharmacokinetics and metabolism of S 38844 after single oral dose administration of [14C]-S 38844 in healthy male volunteers.

Excretion balance, pharmacokinetics and metabolism of S 38844 after single oral dose administration of [14C]-S 38844 in healthy male volunteers. - 14C-S 38844 ADME study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36850

Enrollment

Registered

2012-12-21

Start date

2013-01-15

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

cardiovascular diseases heart- and (blood) vessel diseases

Interventions

The volunteer will receive one dose of 75 mg S 38844 as a 20-mL clear colourless drinking solution which will be dosed in the volunteers mouth by means of syringe.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy Caucasian male volunteers, aged 18 - 64 years inclusive 18.5 * body mass index * 30.0 kg/m2 50 kg * body weight *100 kg

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 90 days from the start of the study. In case of donating of participating in another ADME study in the 12 months prior the start of this study, with a radiation burden of >0,1 mSv.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: Total radioactivity in plasma, urine and faeces Safety: adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination	—

Secondary

Measure	Time frame
Pharmacogenetic sample on (DNA) of 2.5-mL blood at pre-dose on D01.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)