An Open Label, Single Centre Study to Investigate the Metabolic Profile of Dalcetrapib After a Single Oral Dose in Healthy Male Subjects

Hoffmann-La Roche0 sites6 target enrollmentOctober 2011

ConditionsHealthy Volunteer

Interventionsdalcetrapib

Drugsdalcetrapib

Overview

Phase: Phase 1
Intervention: dalcetrapib
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Enrollment: 6
Primary Endpoint: Metabolic Profile: Percentage of Free Thiophenol M1 in the Blood Plasma
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

November 2011

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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