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

This study has been completed.
Sponsor:
Collaborator:
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01191723
First received: August 27, 2010
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

Compare the acute effect on the QT interval of MAP0004 (Dihydroergotamine Mesylate delivered by Oral Inhalation) with Moxifloxacin and Placebo.


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:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in QTcI for MAP0004 3.0mg and Placebo at 30 Minutes [ Time Frame: baseline and 30 minutes ] [ Designated as safety issue: Yes ]
    The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for subject pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.

  • Change From Baseline in QTcI for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours [ Time Frame: baseline and 2 hours ] [ Designated as safety issue: Yes ]
    The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for subject pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.


Secondary Outcome Measures:
  • Change From Baseline in QTcF for MAP0004 3.0mg and Placebo at 30 Minutes [ Time Frame: baseline and 30 minutes ] [ Designated as safety issue: Yes ]
    The Fridericia corrected QT interval(QTcF) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.

  • Change From Baseline in QTcF for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours [ Time Frame: baseline and 2 hours ] [ Designated as safety issue: Yes ]
    The Fridericia corrected QT interval(QTcF) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.

  • Change From Baseline in Heart Rate for MAP0004 3.0mg, Placebo, and Moxifloxacin at 30 Minutes and 2 Hours [ Time Frame: baseline, 30 minutes, and 2 hours ] [ Designated as safety issue: Yes ]
    The heart rate is a measure of how fast or slow the heart beats (measured in beats per minute). A negative change indicates a decrease in heart rate and a positive change indicates an increase in heart rate.


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
Treatment A, then Treatment B, then Treatment C

There was 48 hour wash-out between treatment visits. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.

Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment C = inhaler placebo and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing.

Drug: MAP0004
3.0mg orally inhaled MAP0004 administered in Treatment B as per protocol
Drug: Inhaler Placebo
Placebo for Inhaler administered in Treatments A and C
Drug: Moxifloxacin
400mg encapsulated tablet administered in Treatment A as per protocol
Other Name: Avelox®
Drug: Placebo Capsule
Placebo for Moxifloxacin administered in Treatment B and Treatment C
Treatment A, then Treatment C, then Treatment B

There was 48 hour wash-out between treatment visits. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.

Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing.

Drug: MAP0004
3.0mg orally inhaled MAP0004 administered in Treatment B as per protocol
Drug: Inhaler Placebo
Placebo for Inhaler administered in Treatments A and C
Drug: Moxifloxacin
400mg encapsulated tablet administered in Treatment A as per protocol
Other Name: Avelox®
Drug: Placebo Capsule
Placebo for Moxifloxacin administered in Treatment B and Treatment C
Treatment B, then Treatment A, then Treatment C

There was 48 hour wash-out between treatment visits. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.

Treatment C = inhaler placebo and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing.

Drug: MAP0004
3.0mg orally inhaled MAP0004 administered in Treatment B as per protocol
Drug: Inhaler Placebo
Placebo for Inhaler administered in Treatments A and C
Drug: Moxifloxacin
400mg encapsulated tablet administered in Treatment A as per protocol
Other Name: Avelox®
Drug: Placebo Capsule
Placebo for Moxifloxacin administered in Treatment B and Treatment C
Treatment B, then Treatment C, then Treatment A

There was 48 hour wash-out between treatment visits. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.

Tablets were orally administered after oral inhalation dosing.

Drug: MAP0004
3.0mg orally inhaled MAP0004 administered in Treatment B as per protocol
Drug: Inhaler Placebo
Placebo for Inhaler administered in Treatments A and C
Drug: Moxifloxacin
400mg encapsulated tablet administered in Treatment A as per protocol
Other Name: Avelox®
Drug: Placebo Capsule
Placebo for Moxifloxacin administered in Treatment B and Treatment C
Treatment C, then Treatment A, then Treatment B

There was 48 hour wash-out between treatment visits. Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.

Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing.

Drug: MAP0004
3.0mg orally inhaled MAP0004 administered in Treatment B as per protocol
Drug: Inhaler Placebo
Placebo for Inhaler administered in Treatments A and C
Drug: Moxifloxacin
400mg encapsulated tablet administered in Treatment A as per protocol
Other Name: Avelox®
Drug: Placebo Capsule
Placebo for Moxifloxacin administered in Treatment B and Treatment C
Treatment C, then Treatment B, then Treatment A

There was 48 hour wash-out between treatment visits.

Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.

Tablets were orally administered after oral inhalation dosing.

Drug: MAP0004
3.0mg orally inhaled MAP0004 administered in Treatment B as per protocol
Drug: Inhaler Placebo
Placebo for Inhaler administered in Treatments A and C
Drug: Moxifloxacin
400mg encapsulated tablet administered in Treatment A as per protocol
Other Name: Avelox®
Drug: Placebo Capsule
Placebo for Moxifloxacin administered in Treatment B and Treatment C

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Allergan
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
  More Information

No publications provided by Allergan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01191723     History of Changes
Other Study ID Numbers: MAP0004-CL-P103
Study First Received: August 27, 2010
Results First Received: August 19, 2013
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Allergan:
Healthy Volunteers

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

ClinicalTrials.gov processed this record on August 20, 2014