An open-label, non-randomized, single-center, Phase I trial to investigate the mass balance and the metabolite profile of cilengitide in five healthy subjects

Completed

• Conditions: angiogenesis; cancer; 10027655

• Registration Number: NL-OMON37147
• Lead Sponsor: Merck

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: 5

Inclusion Criteria

Healthy male volunteers
18-45 years, inclusive
BMI: 18.5 * 29.9 kg/m2, inclusive
non-smoking

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 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>Pharmacokinetics/Mass balance<br /><br>Metabolite profiling<br /><br>Safety<br /><br>Blood/Plasma Ratio</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NA</p><br>