A Study of the Metabolic Profile of Dalcetrapib in Healthy Volunteers

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01476267
• Other study ID #: WP27937
• Status: Completed
• Phase: Phase 1
• Start date: October 2011
• Est. completion date: November 2011

Study information

• Verified date: December 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• dalcetrapib
Single oral radiolabeled dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic Profile: Percentage of Free Thiophenol M1 in the Blood Plasma		up to Day 5
Secondary	Correlation of Metabolic Profile With Enzyme/Transporter Genotypes		approximately 3 months