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

Allergan

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Moxifloxacin; Drug: Placebo Capsule; Drug: Inhaler Placebo; Drug: MAP0004

Study type: Interventional

Funder types: Industry

Identifiers

NCT01191723

MAP0004-CL-P103

Details and patient eligibility

About

Compare the acute effect on the QT interval of MAP0004 (Dihydroergotamine Mesylate delivered by Oral Inhalation) with Moxifloxacin and Placebo.

Enrollment: 54 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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54 participants in 6 patient groups

Treatment A, then Treatment B, then Treatment C

Other group

Description:

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:

Drug: Inhaler Placebo

Drug: MAP0004

Drug: Placebo Capsule

Drug: Moxifloxacin

Treatment A, then Treatment C, then Treatment B

Other group

Description:

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:

Drug: Inhaler Placebo

Drug: MAP0004

Drug: Placebo Capsule

Drug: Moxifloxacin

Treatment B, then Treatment A, then Treatment C

Other group

Description:

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:

Drug: Inhaler Placebo

Drug: MAP0004

Drug: Placebo Capsule

Drug: Moxifloxacin

Treatment B, then Treatment C, then Treatment A

Other group

Description:

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:

Drug: Inhaler Placebo

Drug: MAP0004

Drug: Placebo Capsule

Drug: Moxifloxacin

Treatment C, then Treatment A, then Treatment B

Other group

Description:

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:

Drug: Inhaler Placebo

Drug: MAP0004

Drug: Placebo Capsule

Drug: Moxifloxacin

Treatment C, then Treatment B, then Treatment A

Other group

Description:

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.

Treatment:

Drug: Inhaler Placebo

Drug: MAP0004

Drug: Placebo Capsule

Drug: Moxifloxacin