Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole

Allergan

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: IV DHE; Drug: Ketoconazole; Drug: MAP0004

Study type: Interventional

Funder types: Industry

Identifiers

NCT01468558

MAP0004-CL-P104

Details and patient eligibility

About

Compare the DHE pharmacokinetic profiles observed following administration of:

1. MAP0004 (oral inhalation DHE)
2. MAP0004 co-administered with oral Ketoconazole
3. Intravenous (IV) DHE (D.H.E.45®, the approved reference therapy)

Compare the tolerability of MAP0004, IV DHE, and MAP0004 with co-administration of Ketoconazole.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Major Inclusion Criteria:

• Able to provide written Informed Consent
• Male or Female subjects 18 to 45 years old
• Female subjects who are practicing adequate contraception or who are sterile
• Stable cardiac status
• Normal rhythm or arrhythmia deemed clinically insignificant on ECG

Exclusion Criteria:

• Contraindication to dihydroergotamine mesylate (DHE)
• Use of any excluded concomitant medications within the 10 days prior to Visit 1
• History of hemiplegic or basilar migraine
• Participation in another investigational trial during the 12 weeks prior to Visit 1 or during this trial

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

All subjects

Other group

Description:

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).

Treatment:

Drug: MAP0004

Drug: Ketoconazole

Drug: IV DHE