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| Name | Class |
|---|---|
| MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan | INDUSTRY |
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Compare the DHE pharmacokinetic profiles observed following administration of:
Compare the tolerability of MAP0004, IV DHE, and MAP0004 with co-administration of Ketoconazole.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Other | Subjects received MAP0004 on Day 1 of Visit 2, Ketoconazole on Days 3 through 6 of Visit 2, and MAP0004 again on Day 6 of Visit 2. Subjects then returned for Visit 3, 7-11 days from the end of Visit 2. At Visit 3 subjects received 1.0 mg IV DHE (Intravenous Dihydroergotamine Mesylate). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAP0004 | Drug | MAP0004 1.0mg via inhalation on Day 1 and Day 6 of Visit 2 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration | The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Dihydroergotamine is reported in picograms per milliliter (pg/ml). | 48 hours |
| AUC(0-48) of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration | The AUC(0-48) is the area under the plot of plasma concentration of drug against time after drug administration. Dihydroergotamine AUC(0-48) is reported in picograms times hour per milliliter (pg*h/ml). | 48 hours |
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Major Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simbec Research Limited | Merthyr Tydfil | Merthyr Tydfil | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22174351 | Derived | Kellerman D, Kori S, Forst A, Chang J, Febbraro S, Wutann L, Thomas T, Taylor G, Dodick D. Lack of drug interaction between the migraine drug MAP0004 (orally inhaled dihydroergotamine) and a CYP3A4 inhibitor in humans. Cephalalgia. 2012 Jan;32(2):150-8. doi: 10.1177/0333102411432299. Epub 2011 Dec 15. |
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All subjects received MAP0004 on Day 1 of Visit 2, Ketoconazole on Days 3 through 6 of Visit 2, and MAP0004 again on Day 6 of Visit 2. Subjects then returned for Visit 3, 7-11 days from the end of Visit 2. At Visit 3 subjects received 1.0 mg Intravenous (IV) Dihydroergotamine Mesylate (DHE).
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | Subjects first received MAP0004 1.0mg via oral inhalation followed by 48 hours of PK sampling, they then received Ketoconazole (400mg once a day for 4 days) followed by MAP0004 1.0mg and another 48 hours of PK sampling. After a 7-11 day washout, subjects returned to the clinic to receive 1.0mg IV DHE and 48 hours of PK sampling. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | All subjects that were enrolled in the study. |
| 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 | Cmax of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration | The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Dihydroergotamine is reported in picograms per milliliter (pg/ml). | Patients with available data at specified time points are included in the analysis population. | Posted | Geometric Mean | Standard Deviation | pg/ml | 48 hours |
|
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All 24 subjects who received MAP0004 alone, 24 subjects who received MAP0004 with ketoconazole, and 22 subjects who received IV DHE are included in the adverse event analysis. Adverse events are presented by treatment arm, not necessarily by individual treatment (intervention) received.
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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 | MAP0004 1.0mg | MAP0004 1.0mg via inhalation on Day 1 of Visit 2. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Scientific Affairs | MAP Pharmaceuticals Inc., a wholly owned subsidiary of Allergan | 650-386-3100 | dkellerman@mappharma.com |
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| ID | Term |
|---|---|
| D004087 | Dihydroergotamine |
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D004879 | Ergotamines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| IV DHE |
| Drug |
IV DHE (Intravenous Dihydroergotamine Mesylate) administered at Visit 3 |
|
|
| Ketoconazole | Drug | Ketoconazole 400 mg administered once a day on days 3-6 of Visit 2 |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | IV DHE 1.0mg | IV DHE 1.0mg on Day 1 of Visit 3. |
|
|
| Primary | AUC(0-48) of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration | The AUC(0-48) is the area under the plot of plasma concentration of drug against time after drug administration. Dihydroergotamine AUC(0-48) is reported in picograms times hour per milliliter (pg*h/ml). | Patients with available data at specified time points are included in the analysis population. | Posted | Geometric Mean | Standard Deviation | pg*h/ml | 48 hours |
|
|
|
| 0 |
| 24 |
| 6 |
| 24 |
| EG001 | MAP0004 1.0mg + Ketoconazole | Ketoconazole 400mg once a day on Days 3-6 of Visit 2 and MAP0004 1.0mg via inhalation on Day 6 of Visit 2. | 0 | 24 | 7 | 24 |
| EG002 | IV DHE 1.0mg | IV DHE 1.0mg on Day 1 of Visit 3. | 0 | 22 | 11 | 22 |
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D006576 |
| Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |