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A Study of the Metabolic Profile of Dalcetrapib in Healthy Volunteers

CompletedPhase 1

Sponsor: Hoffmann-La Roche

Conditions: Healthy Volunteer

Interventions: dalcetrapib

Countries: Netherlands

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.

Eligibility overview

Sex: MALE

Age: 45 Years to 65 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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

Locations (1)

Zuidlaren, Netherlands