A Study of the Metabolic Profile of Dalcetrapib in Healthy Volunteers

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: dalcetrapib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01476267

WP27937

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

Male

Ages

45 to 65 years old

Volunteers

Accepts Healthy Volunteers

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