Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole
|ClinicalTrials.gov Identifier: NCT01468558|
Recruitment Status : Completed
First Posted : November 9, 2011
Results First Posted : October 22, 2013
Last Update Posted : January 9, 2014
Compare the DHE pharmacokinetic profiles observed following administration of:
- MAP0004 (oral inhalation DHE)
- MAP0004 co-administered with oral Ketoconazole
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: MAP0004 Drug: IV DHE Drug: Ketoconazole||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Evaluation of the Effect of Ketoconazole on the Pharmacokinetics and Safety of Dihydroergotamine Mesylate (DHE) Delivered by Oral Inhalation (MAP0004) in Healthy Volunteers Compared to DHE Delivered Intravenously (DHE 45®)|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2010|
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).
MAP0004 1.0mg via inhalation on Day 1 and Day 6 of Visit 2Drug: IV DHE
IV DHE (Intravenous Dihydroergotamine Mesylate) administered at Visit 3
Other Name: D.H.E.45®Drug: Ketoconazole
Ketoconazole 400 mg administered once a day on days 3-6 of Visit 2
Other Name: Nizoral®
- Cmax of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration [ Time Frame: 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 [ Time Frame: 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01468558
|Simbec Research Limited|
|Merthyr Tydfil, United Kingdom|