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

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 - S 41015 and S 38844 microdosing study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38625

Enrollment

Registered

2013-02-13

Start date

2013-02-15

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

hart- en vaatziekten cardiovascular diseases

Interventions

On Day 1 of Period 1 and 3, and on Day 5 of period 2 of this study the volunteers will receive the study medication as an oral solution of 5 mL containing 500 microgram S 41015 (Period 1 and 2) or S

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: Plasma and urine concentrations, total radioactivity and radioactivity associated to S 41015 (S 38844 and S 41015 in P3) Safety: Adverse events, blood pressure and heart rate measurement, 12-lead ECG, and clinical laboratory parameters	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)