Assessment of pharmacokinetics and pharmacokinetic drug-drug interaction with ketoconazole of the metabolite S 41015 after single oral unlabelled microdoses of S 41015 and i.v. radiolabelled microdoses of [14C]-S 41015, and pharmacokinetics of S 38844 after single oral unlabelled microdose of S 38844 and i.v. radiolabelled microdose of [14C]-S 38844 in healthy male participants
Completed
- Conditions
- hart- en vaatziektencardiovascular diseases
- Registration Number
- NL-OMON38625
- Lead Sponsor
- Institut de Recherches Internationales Servier I.R.I.S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
healthy male Caucasian subjects,
non-smoking or smoking less then 5 cigarettes per day,
EM for CYP2C9,
18 - 45 yrs, inclusive,
18.5 - 30.0 kg/m2, inclusive
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 3 months from the start of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetics: Plasma and urine concentrations, total radioactivity and<br /><br>radioactivity associated to S 41015 (S 38844 and S 41015 in P3)<br /><br>Safety: Adverse events, blood pressure and heart rate measurement, 12-lead ECG,<br /><br>and clinical laboratory parameters</p><br>
- Secondary Outcome Measures
Name Time Method <p>n/a</p><br>
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the CYP3A4-mediated drug-drug interaction between S 41015 and ketoconazole in cardiovascular disease pharmacokinetics?
How do microdosing strategies with [14C]-S 41015 and [14C]-S 38844 compare to standard-dose pharmacokinetics in atherosclerosis treatment development?
Which CYP450 polymorphisms or metabolic biomarkers correlate with variable S 41015/S 38844 clearance in healthy male cardiovascular trial participants?
What are the potential adverse events of S 41015/S 38844 microdosing combined with ketoconazole in preclinical cardiovascular drug studies?
How does Servier's S 41015/S 38844 microdosing approach advance understanding of PDE inhibitors in hypertension and heart failure therapies?