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OpenTrials
Completed

NCT Number: NCT01468558

Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Simbec Research Limited

Merthyr Tydfil, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MAP0004

Drug

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

IV DHE

Drug

IV DHE (Intravenous Dihydroergotamine Mesylate) administered at Visit 3

Other names: D.H.E.45®

Ketoconazole

Drug

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

Other names: Nizoral®

Primary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Collaborators

  • MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

Registry information

Official study 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®)

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 9, 2011
Registry last updated
Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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