QT Intervals Study to Compare the Acute Effects of Orally Inhaled Dihydroergotamine (DHE), Oral Moxifloxacin, and Placebo

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2010-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment A, then Treatment B, then Treatment C

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.

Group Type OTHER

MAP0004

Intervention Type DRUG

3.0mg orally inhaled MAP0004 administered in Treatment B as per protocol

Inhaler Placebo

Intervention Type DRUG

Placebo for Inhaler administered in Treatments A and C

Moxifloxacin

Intervention Type DRUG

400mg encapsulated tablet administered in Treatment A as per protocol

Placebo Capsule

Intervention Type DRUG

Placebo for Moxifloxacin administered in Treatment B and Treatment C

Treatment A, then Treatment C, then Treatment B

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.

Group Type OTHER

MAP0004

Intervention Type DRUG

3.0mg orally inhaled MAP0004 administered in Treatment B as per protocol

Inhaler Placebo

Intervention Type DRUG

Placebo for Inhaler administered in Treatments A and C

Moxifloxacin

Intervention Type DRUG

400mg encapsulated tablet administered in Treatment A as per protocol

Placebo Capsule

Intervention Type DRUG

Placebo for Moxifloxacin administered in Treatment B and Treatment C

Treatment B, then Treatment A, then Treatment C

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.

Group Type OTHER

MAP0004

Intervention Type DRUG

3.0mg orally inhaled MAP0004 administered in Treatment B as per protocol

Inhaler Placebo

Intervention Type DRUG

Placebo for Inhaler administered in Treatments A and C

Moxifloxacin

Intervention Type DRUG

400mg encapsulated tablet administered in Treatment A as per protocol

Placebo Capsule

Intervention Type DRUG

Placebo for Moxifloxacin administered in Treatment B and Treatment C

Treatment B, then Treatment C, then Treatment A

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.

Group Type OTHER

MAP0004

Intervention Type DRUG

3.0mg orally inhaled MAP0004 administered in Treatment B as per protocol

Inhaler Placebo

Intervention Type DRUG

Placebo for Inhaler administered in Treatments A and C

Moxifloxacin

Intervention Type DRUG

400mg encapsulated tablet administered in Treatment A as per protocol

Placebo Capsule

Intervention Type DRUG

Placebo for Moxifloxacin administered in Treatment B and Treatment C

Treatment C, then Treatment A, then Treatment B

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.

Group Type OTHER

MAP0004

Intervention Type DRUG

3.0mg orally inhaled MAP0004 administered in Treatment B as per protocol

Inhaler Placebo

Intervention Type DRUG

Placebo for Inhaler administered in Treatments A and C

Moxifloxacin

Intervention Type DRUG

400mg encapsulated tablet administered in Treatment A as per protocol

Placebo Capsule

Intervention Type DRUG

Placebo for Moxifloxacin administered in Treatment B and Treatment C

Treatment C, then Treatment B, then Treatment A

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.

Group Type OTHER

MAP0004

Intervention Type DRUG

3.0mg orally inhaled MAP0004 administered in Treatment B as per protocol

Inhaler Placebo

Intervention Type DRUG

Placebo for Inhaler administered in Treatments A and C

Moxifloxacin

Intervention Type DRUG

400mg encapsulated tablet administered in Treatment A as per protocol

Placebo Capsule

Intervention Type DRUG

Placebo for Moxifloxacin administered in Treatment B and Treatment C

Interventions

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MAP0004

3.0mg orally inhaled MAP0004 administered in Treatment B as per protocol

Intervention Type DRUG

Inhaler Placebo

Placebo for Inhaler administered in Treatments A and C

Intervention Type DRUG

Moxifloxacin

400mg encapsulated tablet administered in Treatment A as per protocol

Intervention Type DRUG

Placebo Capsule

Placebo for Moxifloxacin administered in Treatment B and Treatment C

Intervention Type DRUG

Other Intervention Names

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Avelox®

Eligibility Criteria

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Inclusion Criteria

1. Able to provide a signed, executed written informed consent
2. Healthy non-smoking adult volunteers: Male or Female subjects 18 to 45 years old
3. Female subjects who are practicing adequate contraception (see section 4.4) or who are sterile
4. No known cardiac disease
5. Normal hemoglobin values
6. Normal or not clinically significant 12-lead Electrocardiogram

* Heart rate ≥ 40 and ≤ 100 at Visit 1 vital signs assessment (resting)
* Subjects with QTcF interval duration \<430 msec for males and \<450 msec for females obtained from the ECG recorder's measurements on the screening ECG taken after at least 5 minutes of quiet rest in supine position
7. Demonstrated ability to properly use the Tempo® Inhaler
8. Subject has not donated blood in the last 56 days

Exclusion Criteria

1. Contraindication to dihydroergotamine mesylate (DHE)
2. History of hemiplegic or basilar migraine
3. Family history of long QT syndrome
4. Participation in another investigational trial during the 30 days prior to Visit 1

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes