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A Study of the Metabolic Profile of Dalcetrapib in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01476267
First received: November 11, 2011
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Healthy Volunteer
 Drug: dalcetrapib
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Metabolic profile: metabolite concentrations (blood/urine/feces) [ Time Frame: up to Day 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of metabolic profile with enzyme/transporter genotypes [ Time Frame: approximately 3 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to 29 days ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: October 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: dalcetrapib
Single oral radiolabeled dose

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476267

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01476267     History of Changes
Other Study ID Numbers: WP27937
Study First Received: November 11, 2011
Last Updated: May 23, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Dalcetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013