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| Name | Class |
|---|---|
| MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan | INDUSTRY |
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Compare the acute effect on the QT interval of MAP0004 (Dihydroergotamine Mesylate delivered by Oral Inhalation) with Moxifloxacin and Placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A, then Treatment B, then Treatment C | Other | There was 48 hour wash-out between treatment visits. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment C = inhaler placebo and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing. |
|
| Treatment A, then Treatment C, then Treatment B | Other | There was 48 hour wash-out between treatment visits. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2. Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing. |
|
| Treatment B, then Treatment A, then Treatment C | Other | There was 48 hour wash-out between treatment visits. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3. Treatment C = inhaler placebo and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing. |
|
| Treatment B, then Treatment C, then Treatment A |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAP0004 | Drug | 3.0mg orally inhaled MAP0004 administered in Treatment B as per protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in QTcI for MAP0004 3.0mg and Placebo at 30 Minutes | The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for subject pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval. | baseline and 30 minutes |
| Change From Baseline in QTcI for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours | The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for subject pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval. | baseline and 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in QTcF for MAP0004 3.0mg and Placebo at 30 Minutes | The Fridericia corrected QT interval(QTcF) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval. | baseline and 30 minutes |
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Inclusion Criteria:
Able to provide a signed, executed written informed consent
Healthy non-smoking adult volunteers: Male or Female subjects 18 to 45 years old
Female subjects who are practicing adequate contraception (see section 4.4) or who are sterile
No known cardiac disease
Normal hemoglobin values
Normal or not clinically significant 12-lead Electrocardiogram
Demonstrated ability to properly use the Tempo® Inhaler
Subject has not donated blood in the last 56 days
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cetero Research | Fargo | North Dakota | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22917853 | Derived | Kori S, Kellerman DJ, Voloshko P, Haugen G. Effects of a supratherapeutic dose of investigational orally inhaled dihydroergotamine (MAP0004) on QT interval: a randomized, double-blind, active- and placebo-controlled crossover study in healthy volunteers. Clin Ther. 2012 Sep;34(9):1920-8. doi: 10.1016/j.clinthera.2012.08.001. Epub 2012 Aug 21. |
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This is a 3-treatment, 3-period, 6-sequence crossover study. Each subject received all 3 treatments in a randomly assigned order: treatments A, B, and C, the sequences were ABC, ACB, BAC, BCA, CAB, and CBA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A, Then B, Then C | Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment C = inhaler placebo and placebo capsules at Visit 4. |
| FG001 | Treatment A, Then C, Then B | Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2. Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4. |
| FG002 | Treatment B, Then A, Then C | Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3. Treatment C = inhaler placebo and placebo capsules at Visit 4. |
| FG003 | Treatment B, Then C, Then A | Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4. |
| FG004 | Treatment C, Then A, Then B | Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4. |
| FG005 | Treatment C, Then B, Then A | Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects 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 | Change From Baseline in QTcI for MAP0004 3.0mg and Placebo at 30 Minutes | The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for subject pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval. | Patients with data available at required time point were included in the analysis population. | Posted | Mean | Standard Deviation | milliseconds | baseline and 30 minutes |
|
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Adverse events are presented by treatment arm, not 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 | Treatment C (Placebo) | Treatment C = inhaler placebo and placebo capsules |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | 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 |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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There was 48 hour wash-out between treatment visits. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4. Tablets were orally administered after oral inhalation dosing. |
|
| Treatment C, then Treatment A, then Treatment B | Other | There was 48 hour wash-out between treatment visits. Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing. |
|
| Treatment C, then Treatment B, then Treatment A | Other | There was 48 hour wash-out between treatment visits. Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4. Tablets were orally administered after oral inhalation dosing. |
|
| Inhaler Placebo | Drug | Placebo for Inhaler administered in Treatments A and C |
|
| Moxifloxacin | Drug | 400mg encapsulated tablet administered in Treatment A as per protocol |
|
|
| Placebo Capsule | Drug | Placebo for Moxifloxacin administered in Treatment B and Treatment C |
|
| Change From Baseline in QTcF for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours |
The Fridericia corrected QT interval(QTcF) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval. |
| baseline and 2 hours |
| Change From Baseline in Heart Rate for MAP0004 3.0mg, Placebo, and Moxifloxacin at 30 Minutes and 2 Hours | The heart rate is a measure of how fast or slow the heart beats (measured in beats per minute). A negative change indicates a decrease in heart rate and a positive change indicates an increase in heart rate. | baseline, 30 minutes, and 2 hours |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
|
|
| Primary | Change From Baseline in QTcI for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours | The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for subject pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval. | Patients with data available at required time point were included in the analysis population. | Posted | Mean | Standard Deviation | milliseconds | baseline and 2 hours |
|
|
|
| Secondary | Change From Baseline in QTcF for MAP0004 3.0mg and Placebo at 30 Minutes | The Fridericia corrected QT interval(QTcF) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval. | Patients with data available at required time point were included in the analysis population. | Posted | Mean | Standard Deviation | milliseconds | baseline and 30 minutes |
|
|
|
| Secondary | Change From Baseline in QTcF for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours | The Fridericia corrected QT interval(QTcF) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval. | Patients with data available at required time point were included in the analysis population. | Posted | Mean | Standard Deviation | milliseconds | baseline and 2 hours |
|
|
|
| Secondary | Change From Baseline in Heart Rate for MAP0004 3.0mg, Placebo, and Moxifloxacin at 30 Minutes and 2 Hours | The heart rate is a measure of how fast or slow the heart beats (measured in beats per minute). A negative change indicates a decrease in heart rate and a positive change indicates an increase in heart rate. | Patients with data available at required time point were included in the analysis population. | Posted | Mean | Standard Deviation | beats per minute (bpm) | baseline, 30 minutes, and 2 hours |
|
|
|
| 0 |
| 54 |
| 2 |
| 54 |
| EG001 | Treatment B (MAP0004 3.0mg) | Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules | 0 | 54 | 26 | 54 |
| EG002 | Treatment A (Moxifloxacin) | Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet | 0 | 54 | 8 | 54 |
| Vomiting | Gastrointestinal 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 |
|
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.
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Change from Baseline at 2 hours |
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