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A Study of the Metabolic Profile of Dalcetrapib in Healthy Volunteers

NCT ID: NCT01476267

Last Updated: 2019-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Single Arm

Group Type EXPERIMENTAL

dalcetrapib

Intervention Type DRUG

Single oral radiolabeled dose

Interventions

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dalcetrapib

Single oral radiolabeled dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Zuidlaren, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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WP27937

Identifier Type: -

Identifier Source: org_study_id