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A single-center, crossover study to evaluate the pharmacokinetics of dalcetrapib and atorvastatin from prototype fixed dose combination formulations in healthy volunteers. Volunteers will receive a single dose of dalcetrapib with atorvastatin in each of four treatment periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | RO5317116/F01 bilayer tablet |
|
| B | Experimental | RO5317116/F03 bilayer tablet |
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| C | Experimental | RO5317116/F04 active-coated tablet |
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| D | Experimental | RO4607381/F49 tablet |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atorvastatin | Drug | single dose of atorvastatin on day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of Dalcetrapib Active Form | 3 days | |
| Plasma Concentration of Atorvastatin | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of Atorvastatin Metabolites | Measuring the amount of byproducts of the metabolization of Atorvastatin in the blood plasma. | 3 days |
| Safety: Incidence of Serious Adverse Events |
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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 |
|---|---|---|---|---|---|---|
| Christchurch | 8011 | New Zealand |
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Study | All AE and Demographic Data is listed for the Total Study Population |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A: RO5317116/F01 Bilayer Tablet |
| |||||||||||||
| B: RO5317116/F03 Bilayer Tablet |
| |||||||||||||
| C: RO5317116/ F04 Active-coated Tablet |
| |||||||||||||
| D: RO4607381/ F49 Tablet |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Study | All AE and Demographic Data is listed for the Total Study Population |
| 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 | Plasma Concentration of Dalcetrapib Active Form | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 3 days |
|
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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 | Total Study | All AE and Demographic Data is listed for the Total Study Population. Data was not collected by arm since all interventions contained the same formulation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendectomy | Surgical and medical procedures |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Black | DalCor Pharmaceuticals | rblack@dalcorpharma.com |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| C411602 | dalcetrapib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| dalcetrapib | Drug | single dose of dalcetrapib on day 1 |
|
| 9 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
RO5317116/F04 active-coated tablet
atorvastatin: single dose of atorvastatin on day 1
dalcetrapib: single dose of dalcetrapib on day 1
| OG003 | D, RO4607381/F49 Tablet | RO4607381/F49 tablet atorvastatin: single dose of atorvastatin on day 1 dalcetrapib: single dose of dalcetrapib on day 1 |
|
|
| Primary | Plasma Concentration of Atorvastatin | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 3 days |
|
|
|
| Secondary | Plasma Concentration of Atorvastatin Metabolites | Measuring the amount of byproducts of the metabolization of Atorvastatin in the blood plasma. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/ml | 3 days |
|
|
|
| Secondary | Safety: Incidence of Serious Adverse Events | Posted | Number | Events | 9 weeks |
|
|
|
| 0 |
| 24 |
| 8 |
| 24 |
| Inguinal Hernia Repair | Surgical and medical procedures |
|
| Seasonal Allergy | Immune system disorders |
|
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| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |