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

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 - Cilengitide mass balance study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37147

Enrollment

Registered

2012-10-16

Start date

2012-11-02

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

angiogenesis cancer

Interventions

One intravenous infusion of 2000 mg 14C labeled cilengitide in 250 ml over 60 minutes

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics/Mass balance Metabolite profiling Safety Blood/Plasma Ratio	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)