A Study of the Metabolic Profile of Dalcetrapib in Healthy Volunteers
- Registration Number
- NCT01476267
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This single center, open-label, non-randomized, one-treatment, one-period study will evaluate the metabolic profile and the safety of a single oral radiolabeled dose of dalcetrapib in male healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
Inclusion Criteria
- Healthy male subjects, 45 to 65 years of age inclusive
- Body mass index (BMI) between 18 and 32 kg/m2 inclusive
Exclusion Criteria
- Any concomitant disease or ongoing condition that in the investigator's opinion could interfere with the study or could pose an unacceptable risk to the subject
- Clinically significant abnormal laboratory values
- Infrequent bowel movements (e.g. less than one movement per 24 h on average)
- An intent to father children within 3 months of dosing
- Any external or internal radiotherapy with open (nuclear medicine) or sealed sources (brachy therapy)
- External irradiation (radiological examination) or internal radiation (diagnostic nuclear medicine procedure) within one year before study drug dosing; dental radiography and plain X-rays of the extremities are allowed before dosing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm dalcetrapib -
- Primary Outcome Measures
Name Time Method Metabolic Profile: Percentage of Free Thiophenol M1 in the Blood Plasma up to Day 5
- Secondary Outcome Measures
Name Time Method Correlation of Metabolic Profile With Enzyme/Transporter Genotypes approximately 3 months