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: August 4, 2014
Last verified: August 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 4, 2014
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 September 18, 2014