Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole
This study has been completed.
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Information provided by (Responsible Party):
First received: October 28, 2011
Last updated: December 9, 2013
Last verified: December 2013
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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®)|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Allergan:
Primary Outcome Measures:
- Cmax of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration [ Time Frame: 48 hours ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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).
|Study Start Date:||July 2010|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
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®
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