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| Name | Class |
|---|---|
| MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan | INDUSTRY |
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Compare the pharmacokinetics of Dihydroergotamine Mesylate (DHE) delivered by oral inhalation (MAP0004) or Intravenous (IV) DHE in smokers versus non-smokers.
Identify whether there are clinically significant differences in the tolerability of MAP0004 between smokers and non-smokers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV DHE then MAP0004 | Other | Smokers and non-smokers received Intravenous Dihydroergotamine Mesylate (IV DHE) at Visit 2 followed by MAP0004 7-11 days later at Visit 3. |
|
| MAP0004 then IV DHE | Other | Smokers and non-smokers received MAP0004 at Visit 2 followed by Intravenous Dihydroergotamine Mesylate (IV DHE) 7-11 days later at Visit 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAP0004 | Drug | 1.0mg MAP0004 via inhalation at Visit 2 or 3 as per protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers Versus Non-smokers | 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 and IV DHE Administration in Smokers and Non-smokers | 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:
Major Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simbec Research Limited | Merthyr Tydfil | Merthyr Tydfil | CF48 4DR | United Kingdom |
All smoking and non-smoking subjects received both MAP0004 and Intravenous (IV) Dihydroergotamine (DHE).
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| ID | Title | Description |
|---|---|---|
| FG000 | Smokers | Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result. |
| FG001 | Non-smokers | Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Smokers | Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result. |
| BG001 | Non-smokers | Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening. |
| 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 and IV DHE Administration in Smokers Versus Non-smokers | 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 non-smoking subjects who received MAP0004 and IV DHE and 23 smoking subjects who received MAP0004 and 22 of the 23 smoking subjects received IV DHE were included in the adverse event analysis.
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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 Smokers | Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving MAP0004 at either Visit 2 or 3. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue 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 |
| ID | Term |
|---|---|
| D004879 | Ergotamines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| IV DHE | Drug | IV DHE administered at Visit 2 or 3 as per protocol |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving MAP0004 at either Visit 2 or 3. |
| OG002 | IV DHE 1.0mg Smokers | Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving IV DHE at either Visit 2 or 3. |
| OG003 | IV DHE 1.0mg Non-smokers | Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving IV DHE at either Visit 2 or 3. |
|
|
| Primary | AUC(0-48) of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers and Non-smokers | 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 |
| 23 |
| 4 |
| 23 |
| EG001 | MAP0004 1.0mg Non-smokers | Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving MAP0004 at either Visit 2 or 3. | 0 | 24 | 8 | 24 |
| EG002 | IV DHE 1.0mg Smokers | Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving IV DHE at either Visit 2 or 3. | 0 | 22 | 15 | 22 |
| EG003 | IV DHE 1.0mg Non-smokers | Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving IV DHE at either Visit 2 or 3. | 0 | 24 | 22 | 24 |
| Neck pain | Musculoskeletal and connective tissue 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 |
|
| Paraesthesia | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Feeling hot | General 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 |