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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01GM063674-07 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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To evaluate two paradigms for simultaneous assessment of hepatic and intestinal CYP3A activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alfentanil | Experimental | Alfentanil (0.5-1 mg IV bolus) followed 3 hours later or simultaneously by 1-4 mg oral deuterium-labeled (d3) alfentanil on each study visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alfentanil | Drug | No drug treatment before alfentanil |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity | AUC(0-inf) | 9 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evan D Kharasch, MD, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University/Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Sequential Alfentanil | Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil. Control. |
| FG001 | Rifampin Sequential Alfentanil | Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil after 5d rifampin pretreatment |
| FG002 | Grapefruit Juice Sequential Alfentanil | Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil after 3 oz double strength oral grapefruit juice |
| FG003 | Ketoconazole Sequential Alfentanil | Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil after 3d ketoconazole |
| FG004 | Control Simultaneous Alfentanil | Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil.Control. |
| FG005 | Rifampin Simultaneous Alfentanil | Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil after 5d rifampin pretreatment |
| FG006 | Grapefruit Juice Simultaneous Alfentanil | Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil after 3 oz double strength oral grapefruit juice |
| FG007 | Ketoconazole Simultaneous Alfentanil | Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil after 3d ketoconazole |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Control Sequential Alfentanil |
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| Rifampin Sequential Alfentanil |
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| Grapefruit Juice Sequential Alfentanil |
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| Ketoconazole Sequential Alfentanil |
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| Control Simultaneous Alfentanil |
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| Rifampin Simultaneous Alfentanil |
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| Grapefruit Juice Simultaneous Alfentanil |
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| Ketoconazole Simultaneous Alfentanil |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alfentanil |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity | AUC(0-inf) | Posted | Mean | Standard Deviation | (hr*ng/ml/mg) | 9 hours |
|
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1 year
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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 | Control Sequential Alfentanil | Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil. Control. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea/Vomitting | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Evan D. Kharasch, MD PhD | Washington University | 314-362-8796 | kharasch@wustl.edu |
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| ID | Term |
|---|---|
| D015760 | Alfentanil |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Refampin Sequential Alfentanil | Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil after 5d rifampin pretreatment | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Grapefruit Juice Sequential Alfentanil | Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil after 3 oz double strength oral grapefruit juice | 0 | 6 | 0 | 6 | 1 | 6 |
| EG003 | Ketoconazole Sequential Alfentanil | Alfentanil (IV bolus) followed 3 hours later by oral deuterium-labeled (d3) alfentanil after 3d ketoconazole | 0 | 6 | 0 | 6 | 0 | 6 |
| EG004 | Control Simultaneous Alfentanil | Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil.Control | 0 | 6 | 0 | 6 | 0 | 6 |
| EG005 | Rifampin Simultaneous Alfentanil | Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil after 5d rifampin pretreatment | 0 | 6 | 0 | 6 | 0 | 6 |
| EG006 | Grapefruit Juice Simultaneous Alfentanil | Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil after 3 oz double strength oral grapefruit juice | 0 | 6 | 0 | 6 | 0 | 6 |
| EG007 | Ketoconazole Simultaneous Alfentanil | Alfentanil (IV bolus) and simultaneous oral deuterium-labeled (d3) alfentanil after 3d ketoconazole | 0 | 6 | 0 | 6 | 0 | 6 |
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