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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35295

Enrollment

Registered

2011-10-07

Start date

2011-10-18

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary heart disease

Interventions

Study Medication Active substance: dalcetrapib and [14C]-dalcetrapib Activity: CETP inhibitor Indication: coronary heart disease (CHD) Strength: 150 mg Dosage form: capsule Treatment A single oral

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Radiokinetics: total radioactivity in plasma, urine and faeces, mass balance, radiokinetic parameters Pharmacokinetics: plasma dalcetrapib concentrations, pharmacokinetic parameters, metabolite profiling Safety: adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)