HealthyPhase 1NCT01191723

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

A Phase 1 study testing MAP0004 and Moxifloxacin in people with Healthy, run by Allergan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: MAP0004 and Moxifloxacin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 54 participants
Where: 1 siteUnited States
Study dates: Aug 2010to Sep 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Able to provide a signed, executed written informed consent
Healthy non-smoking adult volunteers: Male or Female subjects 18 to 45 years old
Female subjects who are practicing adequate contraception (see section 4.4) or who are sterile
No known cardiac disease
Normal hemoglobin values
Normal or not clinically significant 12-lead Electrocardiogram

Show all 10Show fewer

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
Demonstrated ability to properly use the Tempo® Inhaler
Subject has not donated blood in the last 56 days

Who cannot join

Contraindication to dihydroergotamine mesylate (DHE)
History of hemiplegic or basilar migraine
Family history of long QT syndrome
Participation in another investigational trial during the 30 days prior to Visit 1

Trial locations and contacts

1 site in 1 country.

United States1 site

Cetero Research
Fargo, North Dakota

Other trials in United States

About this study

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

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

Conditions: Healthy
Being tested: MAP0004, Inhaler Placebo, Moxifloxacin, Placebo Capsule
Keywords: Healthy Volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MAP0004Drug
3.0mg orally inhaled MAP0004 administered in Treatment B as per protocol
Inhaler PlaceboDrug
Placebo for Inhaler administered in Treatments A and C
MoxifloxacinDrug
Also called Avelox®
400mg encapsulated tablet administered in Treatment A as per protocol
Placebo CapsuleDrug
Placebo for Moxifloxacin administered in Treatment B and Treatment C

Study groups in NCT01191723
Study group	Role	What they receive
Treatment A, then Treatment B, then Treatment C	Other	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. Receives: Drug: MAP0004; Drug: Inhaler Placebo; Drug: Moxifloxacin; Drug: Placebo Capsule
Treatment A, then Treatment C, then Treatment B	Other	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. Receives: Drug: MAP0004; Drug: Inhaler Placebo; Drug: Moxifloxacin; Drug: Placebo Capsule
Treatment B, then Treatment A, then Treatment C	Other	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. Receives: Drug: MAP0004; Drug: Inhaler Placebo; Drug: Moxifloxacin; Drug: Placebo Capsule
Treatment B, then Treatment C, then Treatment A	Other	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. Receives: Drug: MAP0004; Drug: Inhaler Placebo; Drug: Moxifloxacin; Drug: Placebo Capsule
Treatment C, then Treatment A, then Treatment B	Other	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. Receives: Drug: MAP0004; Drug: Inhaler Placebo; Drug: Moxifloxacin; Drug: Placebo Capsule
Treatment C, then Treatment B, then Treatment A	Other	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. Receives: Drug: MAP0004; Drug: Inhaler Placebo; Drug: Moxifloxacin; Drug: Placebo Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in QTcI for MAP0004 3.0mg and Placebo at 30 Minutes
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.
Measured: baseline and 30 minutes
Change From Baseline in QTcI for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours
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.
Measured: baseline and 2 hours

Secondary outcomes (3)

Change From Baseline in QTcF for MAP0004 3.0mg and Placebo at 30 Minutes
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.
Measured: baseline and 30 minutes
Change From Baseline in QTcF for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours
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.
Measured: baseline and 2 hours
Change From Baseline in Heart Rate for MAP0004 3.0mg, Placebo, and Moxifloxacin at 30 Minutes and 2 Hours
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.
Measured: baseline, 30 minutes, and 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Sep 2010

First posted31 Aug 2010 (estimated)
Study startAug 2010
Primary completionSep 2010
Study completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01191723
Sponsor's protocol ID: MAP0004-CL-P103
Status last verified: Dec 2013
First submitted: 27 Aug 2010
Last updated: 9 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kori S, Kellerman DJ, Voloshko P, Haugen G. Effects of a supratherapeutic dose of investigational orally inhaled dihydroergotamine (MAP0004) on QT interval: a randomized, double-blind, active- and placebo-controlled crossover study in healthy volunteers. Clin Ther. 2012 Sep;34(9):1920-8. doi: 10.1016/j.clinthera.2012.08.001. Epub 2012 Aug 21.
PubMed 22917853

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01191723
Acronym / sponsor ID: MAP0004-CL-P103
Conditions: Healthy
Keywords: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Collaborators: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Study start: Aug 2010
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 31 Aug 2010 (estimated)
Results: Posted 22 Oct 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Treatment A, then Treatment B, then Treatment C	Other	Drug: MAP0004, Drug: Inhaler Placebo, Drug: Moxifloxacin, Drug: Placebo CapsuleThere 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.
Treatment A, then Treatment C, then Treatment B	Other	Drug: MAP0004, Drug: Inhaler Placebo, Drug: Moxifloxacin, Drug: Placebo CapsuleThere 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.
Treatment B, then Treatment A, then Treatment C	Other	Drug: MAP0004, Drug: Inhaler Placebo, Drug: Moxifloxacin, Drug: Placebo CapsuleThere 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.
Treatment B, then Treatment C, then Treatment A	Other	Drug: MAP0004, Drug: Inhaler Placebo, Drug: Moxifloxacin, Drug: Placebo CapsuleThere 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.
Treatment C, then Treatment A, then Treatment B	Other	Drug: MAP0004, Drug: Inhaler Placebo, Drug: Moxifloxacin, Drug: Placebo CapsuleThere 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.
Treatment C, then Treatment B, then Treatment A	Other	Drug: MAP0004, Drug: Inhaler Placebo, Drug: Moxifloxacin, Drug: Placebo CapsuleThere 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.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (4 listed)

Contraindication to dihydroergotamine mesylate (DHE)
History of hemiplegic or basilar migraine
Family history of long QT syndrome
Participation in another investigational trial during the 30 days prior to Visit 1

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MAP00043.0mg orally inhaled MAP0004 administered in Treatment B as per protocol	Drug	Treatment A, then Treatment B, then Treatment C, Treatment A, then Treatment C, then Treatment B, Treatment B, then Treatment A, then Treatment C, Treatment B, then Treatment C, then Treatment A, Treatment C, then Treatment A, then Treatment B, Treatment C, then Treatment B, then Treatment A
Inhaler PlaceboPlacebo for Inhaler administered in Treatments A and C	Drug	Treatment A, then Treatment B, then Treatment C, Treatment A, then Treatment C, then Treatment B, Treatment B, then Treatment A, then Treatment C, Treatment B, then Treatment C, then Treatment A, Treatment C, then Treatment A, then Treatment B, Treatment C, then Treatment B, then Treatment A
MoxifloxacinAlso: Avelox®400mg encapsulated tablet administered in Treatment A as per protocol	Drug	Treatment A, then Treatment B, then Treatment C, Treatment A, then Treatment C, then Treatment B, Treatment B, then Treatment A, then Treatment C, Treatment B, then Treatment C, then Treatment A, Treatment C, then Treatment A, then Treatment B, Treatment C, then Treatment B, then Treatment A
Placebo CapsulePlacebo for Moxifloxacin administered in Treatment B and Treatment C	Drug	Treatment A, then Treatment B, then Treatment C, Treatment A, then Treatment C, then Treatment B, Treatment B, then Treatment A, then Treatment C, Treatment B, then Treatment C, then Treatment A, Treatment C, then Treatment A, then Treatment B, Treatment C, then Treatment B, then Treatment A

Primary outcome

Change From Baseline in QTcI for MAP0004 3.0mg and Placebo at 30 Minutes
Time frame: baseline and 30 minutes
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
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.

3 secondary outcomes

Change From Baseline in QTcF for MAP0004 3.0mg and Placebo at 30 Minutes
Time frame: baseline and 30 minutes
Change From Baseline in QTcF for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours
Time frame: baseline and 2 hours
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

Results and safety

Results posted to the registry on 22 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment A, Then B, Then C	9	9
Treatment A, Then C, Then B	9	9
Treatment B, Then A, Then C	9	9
Treatment B, Then C, Then A	9	9
Treatment C, Then A, Then B	9	9
Treatment C, Then B, Then A	9	9

Primary outcome: Change From Baseline in QTcI for MAP0004 3.0mg and Placebo at 30 Minutes

Time frame: baseline and 30 minutes. Mean (Standard Deviation). Unit: milliseconds

Measure	Treatment C (Placebo) n = 52	Treatment B (MAP0004 3.0mg) n = 54
Baseline	408.8 (20.1)	409.6 (20.9)
Change from Baseline at 30 mins	-4.7 (6.2)	-4.6 (7.3)

Population analysed: Patients with data available at required time point were included in the analysis population.

Primary outcome: Change From Baseline in QTcI for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours

Time frame: baseline and 2 hours. Mean (Standard Deviation). Unit: milliseconds

Measure	Treatment C (Placebo) n = 52	Treatment B (MAP0004 3.0mg) n = 54	Treatment A (Moxifloxacin) n = 54
Baseline	408.8 (20.1)	409.6 (20.9)	408.6 (20.0)
Change from Baseline at 2 hours	-2.3 (7.0)	-5.1 (6.7)	9.0 (6.8)

Population analysed: Patients with data available at required time point were included in the analysis population.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment C (Placebo)	0 of 54 (0%)	2 of 54 (3.7%)	Not reported
Treatment B (MAP0004 3.0mg)	0 of 54 (0%)	26 of 54 (48.1%)	Not reported
Treatment A (Moxifloxacin)	0 of 54 (0%)	8 of 54 (14.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22917853Kori S, Kellerman DJ, Voloshko P, Haugen G. Effects of a supratherapeutic dose of investigational orally inhaled dihydroergotamine (MAP0004) on QT interval: a randomized, double-blind, active- and placebo-controlled crossover study in healthy volunteers. Clin Ther. 2012 Sep;34(9):1920-8. doi: 10.1016/j.clinthera.2012.08.001. Epub 2012 Aug 21.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MAP0004 and Moxifloxacin in people with Healthy, run by Allergan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in QTcI for MAP0004 3.0mg and Placebo at 30 Minutes (time frame: baseline and 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01191723, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2014; AzTrials last refreshed its copy on 7 Nov 2026.