A Study of the Metabolic Profile of Dalcetrapib in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01476267
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: dalcetrapib Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Open Label, Single Centre Study to Investigate the Metabolic Profile of Dalcetrapib After a Single Oral Dose in Healthy Male Subjects
Study Start Date : October 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Arm Intervention/treatment
Experimental: Single Arm Drug: dalcetrapib
Single oral radiolabeled dose

Primary Outcome Measures :
  1. Metabolic profile: metabolite concentrations (blood/urine/feces) [ Time Frame: up to Day 5 ]

Secondary Outcome Measures :
  1. Correlation of metabolic profile with enzyme/transporter genotypes [ Time Frame: approximately 3 months ]
  2. Safety: Incidence of adverse events [ Time Frame: up to 29 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01476267

Zuidlaren, Netherlands, 9471 GP
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01476267     History of Changes
Other Study ID Numbers: WP27937
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents