Status:
COMPLETED
A Study of the Metabolic Profile of Dalcetrapib in Healthy Volunteers
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
MALE
45-65 years
Phase:
PHASE1
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 vol...
Eligibility Criteria
Inclusion
- Healthy male subjects, 45 to 65 years of age inclusive
- Body mass index (BMI) between 18 and 32 kg/m2 inclusive
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01476267
Start Date
October 1 2011
End Date
November 1 2011
Last Update
December 17 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Zuidlaren, Netherlands, 9471 GP