Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: MAP0004; Drug: IV DHE; Drug: Ketoconazole

• Registration Number: NCT01468558
• Lead Sponsor: Allergan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2011-10-28
• Study First Submitted QC: 2011-11-07
• Study First Posted: 2011-11-09
• Results First Submitted: 2013-08-19
• Results First Submitted QC: 2013-08-19
• Results First Posted: 2013-10-22
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-09
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All subjects	MAP0004	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).
All subjects	IV DHE	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).
All subjects	Ketoconazole	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).

Primary Outcome Measures

Name	Time	Method
Cmax of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration	48 hours	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).
AUC(0-48) of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration	48 hours	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).

Trial Locations

Locations (1)

Simbec Research Limited; 🇬🇧 Merthyr Tydfil, United Kingdom