A Study of the Metabolic Profile of Dalcetrapib in Healthy Volunteers

December 13, 2019 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Single Arm
Drug: dalcetrapib
Single oral radiolabeled dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Metabolic Profile: Percentage of Free Thiophenol M1 in the Blood Plasma
Time Frame: up to Day 5
up to Day 5

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation of Metabolic Profile With Enzyme/Transporter Genotypes
Time Frame: approximately 3 months
approximately 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

November 11, 2011

First Submitted That Met QC Criteria

November 17, 2011

First Posted (ESTIMATE)

November 22, 2011

Study Record Updates

Last Update Posted (ACTUAL)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 13, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WP27937

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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