An open label, single center study to investigate the metabolic profile of dalcetrapib after a single oral dose in healthy male subjects

Completed

• Conditions: coronary heart disease; 10011082

• Registration Number: NL-OMON35295
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

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

Inclusion Criteria

- healthy male subjects
- 45-65 yrs, inclusive
- BMI:18-32 kg/m2, inclusive
- non-smoker or moderate smoker (* 5 cigarettes per day)

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Radiokinetics: total radioactivity in plasma, urine and faeces, mass balance,<br /><br>radiokinetic parameters<br /><br>Pharmacokinetics: plasma dalcetrapib concentrations, pharmacokinetic<br /><br>parameters, metabolite profiling<br /><br>Safety: adverse events, vital signs, ECG-parameters, laboratory parameters,<br /><br>physical examination</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N/A</p><br>