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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: June 3, 2013
Last verified: June 2013
History of Changes

November 11, 2011
June 3, 2013
October 2011
November 2011   (final data collection date for primary outcome measure)
Metabolic profile: metabolite concentrations (blood/urine/feces) [ Time Frame: up to Day 5 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01476267 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of the Metabolic Profile of Dalcetrapib in Healthy Volunteers
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Healthy Volunteer
Drug: dalcetrapib
Single oral radiolabeled dose
Experimental: Single Arm
Intervention: Drug: dalcetrapib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Male
45 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01476267
WP27937
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP