Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole

Allergan24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

MAP0004DRUG

MAP0004 1.0mg via inhalation on Day 1 and Day 6 of Visit 2

IV DHEDRUG

IV DHE (Intravenous Dihydroergotamine Mesylate) administered at Visit 3

KetoconazoleDRUG

Ketoconazole 400 mg administered once a day on days 3-6 of Visit 2

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Simbec Research Limited

Merthyr Tydfil, Merthyr Tydfil, United Kingdom

Outcomes

Primary Outcomes

Cmax of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration

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).

Time frame: 48 hours

AUC(0-48) of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration

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).

Time frame: 48 hours

Data from ClinicalTrials.gov

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