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QT Intervals Study to Compare the Acute Effects of Orally Inhaled Dihydroergotamine (DHE), Oral Moxifloxacin, and Placebo

This study has been completed.
Sponsor:
Information provided by:
MAP Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01191723
First received: August 27, 2010
Last updated: February 8, 2011
Last verified: September 2010
History of Changes
  Purpose

The purpose of this study is to:

  • Compare the acute effect of MAP0004 (Dihydroergotamine Mesylate delivered by Oral Inhalation), Moxifloxacin and Placebo on the QT interval (corrected by Fridericia and Individualized)
  • Assess the tolerability of MAP0004
  • Assess DHE systemic exposure via oral inhalation
  • Assess whether there is any relationship between DHE plasma concentrations achieved and changes in corrected QT interval

Condition Intervention Phase
Healthy
 Drug: MAP0004
Drug: Inhaler Placebo
Drug: Moxifloxacin
Drug: Placebo Capsule
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled, Three- Period Crossover Study Comparing the Acute Effects of Orally Inhaled Dihydroergotamine (DHE), Oral Moxifloxacin, and Placebo on QT Intervals in Healthy Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by MAP Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Compare the acute effect of MAP0004 (Dihydroergotamine Mesylate delivered by Oral Inhalation), Moxifloxacin and Placebo on the QT interval (corrected by Fridericia and Individualized) [ Time Frame: 24 hour baseline and 24 hour post dose ] [ Designated as safety issue: Yes ]
  • Change in QT interval [ Time Frame: 0 min, 5 min, 10 min, 15 min, 20 min, 30 min, 60 min, 120 min, 180 min, 240 min, 360 min, 720 min, 24 hr. ] [ Designated as safety issue: Yes ]
    Change in QT interval (corrected by the formulas of Fridericia andIndividualized) from the baseline period compared to placebo and Moxifloxacin respectively at each time point.


Estimated Enrollment: 54
Study Start Date: August 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Inhaler Placebo Drug: Inhaler Placebo
Placebo for Inhaler
Experimental: MAP0004 Drug: MAP0004
Orally inhaled DHE
Active Comparator: Moxifloxacin Drug: Moxifloxacin
Active Control
Placebo Comparator: Placebo capsules Drug: Placebo Capsule
Placebo for Moxifloxacin

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Able to provide a signed, executed written informed consent
  2. Healthy non-smoking adult volunteers: Male or Female subjects 18 to 45 years old
  3. Female subjects who are practicing adequate contraception (see section 4.4) or who are sterile
  4. No known cardiac disease
  5. Normal hemoglobin values

  6. Normal or not clinically significant 12-lead Electrocardiogram

    • Heart rate ≥ 40 and ≤ 100 at Visit 1 vital signs assessment (resting)
    • Subjects with QTcF interval duration <430 msec for males and <450 msec for females obtained from the ECG recorder's measurements on the screening ECG taken after at least 5 minutes of quiet rest in supine position
  7. Demonstrated ability to properly use the Tempo® Inhaler
  8. Subject has not donated blood in the last 56 days

Exclusion Criteria:

  1. Contraindication to dihydroergotamine mesylate (DHE)
  2. History of hemiplegic or basilar migraine
  3. Family history of long QT syndrome
  4. Participation in another investigational trial during the 30 days prior to Visit 1
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191723

Locations
United States, North Dakota
Cetero Research
Fargo, North Dakota, United States
Sponsors and Collaborators
MAP Pharmaceuticals, Inc.
  More Information

No publications provided by MAP Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medical Affairs at MAP Pharmaceuticals, MAP Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01191723     History of Changes
Other Study ID Numbers: MAP0004-CL-P103
Study First Received: August 27, 2010
Last Updated: February 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by MAP Pharmaceuticals, Inc.:
Healthy Volunteers

Additional relevant MeSH terms:
Dihydroergotamine
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Agents
Anti-Infective Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on June 18, 2013