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
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 11, 2011
CompletedFirst Posted
Study publicly available on registry
November 22, 2011
CompletedResults Posted
Study results publicly available
December 17, 2019
CompletedDecember 17, 2019
December 1, 2019
1 month
November 11, 2011
July 17, 2019
December 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Metabolic Profile: Percentage of Free Thiophenol M1 in the Blood Plasma
up to Day 5
Secondary Outcomes (1)
Correlation of Metabolic Profile With Enzyme/Transporter Genotypes
approximately 3 months
Study Arms (1)
Single Arm
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy male subjects, 45 to 65 years of age inclusive
- Body mass index (BMI) between 18 and 32 kg/m2 inclusive
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Zuidlaren, 9471 GP, Netherlands
MeSH Terms
Interventions
Results Point of Contact
- Title
- Ryan Black
- Organization
- DalCor Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2011
First Posted
November 22, 2011
Study Start
October 1, 2011
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
December 17, 2019
Results First Posted
December 17, 2019
Record last verified: 2019-12