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

Completed

• Conditions: cardiovascular diseases; heart- and (blood) vessel diseases; 10082206; 10057166

• Registration Number: NL-OMON36850
• Lead Sponsor: Institut de Recherches Internationales Servier I.R.I.S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics: Total radioactivity in plasma, urine and faeces<br /><br>Safety: adverse events, vital signs, ECG-parameters, laboratory parameters,<br /><br>physical examination</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pharmacogenetic sample on (DNA) of 2.5-mL blood at pre-dose on D01.</p><br>