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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dalcetrapib | Drug | Single oral radiolabeled dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic Profile: Percentage of Free Thiophenol M1 in the Blood Plasma | up to Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Metabolic Profile With Enzyme/Transporter Genotypes | approximately 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuidlaren | 9471 GP | Netherlands |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | dalcetrapib: Single oral radiolabeled dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | dalcetrapib: Single oral radiolabeled dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Metabolic Profile: Percentage of Free Thiophenol M1 in the Blood Plasma | Posted | Mean | Standard Deviation | Percentage of Free Thiophenol M1 | up to Day 5 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm | dalcetrapib: Single oral radiolabeled dose |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Black | DalCor Pharmaceuticals | rblack@dalcorpharma.com |
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| ID | Term |
|---|---|
| C411602 | dalcetrapib |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Correlation of Metabolic Profile With Enzyme/Transporter Genotypes | Data was not collected | Posted | approximately 3 months |
|
|
| 0 |
| 6 |
| 4 |
| 6 |
| Abdominal Distension | Gastrointestinal disorders |
|
| Flatulence | Gastrointestinal disorders |
|
| Toothache | Gastrointestinal disorders |
|
| Headache | Nervous system disorders |
|
| Neck Pain | Musculoskeletal and connective tissue disorders |
|
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