Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole
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|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 2
Drug: IV DHE
IV DHE (Intravenous Dihydroergotamine Mesylate) administered at Visit 3
Other Name: D.H.E.45®
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01468558
|Simbec Research Limited|
|Merthyr Tydfil, United Kingdom|