A Study of the Metabolic Profile of Dalcetrapib in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: dalcetrapib

• 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

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Study First Submitted: 2011-11-11
• Study First Submitted QC: 2011-11-17
• Study First Posted: 2011-11-22
• Results First Submitted: 2019-07-17
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-13
• Last Update Submitted: 2019-12-13
• Results First Posted: 2019-12-17
• Last Update Posted: 2019-12-17

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