Healthy SubjectsPhase 1/2NCT01199965

Pharmacokinetics & Tolerability Study of MAP0004 in Smoking and Non-Smoking Adult Volunteers

A Phase 1/2 study testing MAP0004 and IV DHE in people with Healthy Subjects, run by Allergan at 1 site in United Kingdom.

Completed

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

Official record

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Trial summary

Compare the pharmacokinetics of Dihydroergotamine Mesylate (DHE) delivered by oral inhalation (MAP0004) or Intravenous (IV) DHE in smokers versus non-smokers. Identify whether there are clinically significant differences in the tolerability of MAP0004 between smokers and non-smokers. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: MAP0004 and IV DHE
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 1 siteUnited Kingdom
Study dates: Jan 2010to Apr 2010
Phase: Phase 1/2
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

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

Major Exclusion Criteria:

Contraindication to dihydroergotamine mesylate (DHE)
Use of any excluded concomitant medications within the 10 days prior to Visit 1 (See Section 5.5)
History of hemiplegic or basilar migraine
Participation in another investigational trial during the 30 days prior to Visit 1 or during this trial

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Simbec Research Limited
Merthyr Tydfil, Merthyr Tydfil, CF48 4DR

Other trials in United Kingdom

About this study

Official title: An Open-Label, 2-Period, Crossover Phase 2 Study Comparing the Pharmacokinetics and Tolerability of Dihydroergotamine Mesylate (DHE) Delivered Intravenously (DHE 45) and by Oral Inhalation (MAP0004) in Smoking and Non-Smoking Adult Volunteers

Compare the pharmacokinetics of Dihydroergotamine Mesylate (DHE) delivered by oral inhalation (MAP0004) or Intravenous (IV) DHE in smokers versus non-smokers.

Identify whether there are clinically significant differences in the tolerability of MAP0004 between smokers and non-smokers.

Conditions: Healthy Subjects
Being tested: MAP0004, IV DHE

What participants receive

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

MAP0004Drug
1.0mg MAP0004 via inhalation at Visit 2 or 3 as per protocol
IV DHEDrug
Also called D.H.E.45®
IV DHE administered at Visit 2 or 3 as per protocol

Study groups in NCT01199965
Study group	Role	What they receive
IV DHE then MAP0004	Other	Smokers and non-smokers received Intravenous Dihydroergotamine Mesylate (IV DHE) at Visit 2 followed by MAP0004 7-11 days later at Visit 3. Receives: Drug: MAP0004; Drug: IV DHE
MAP0004 then IV DHE	Other	Smokers and non-smokers received MAP0004 at Visit 2 followed by Intravenous Dihydroergotamine Mesylate (IV DHE) 7-11 days later at Visit 3. Receives: Drug: MAP0004; Drug: IV DHE

What is being measured

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

Cmax of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers Versus Non-smokers
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).
Measured: 48 hours
AUC(0-48) of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers and Non-smokers
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).
Measured: 48 hours

Timeline

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

Jan 2010Apr 2010

First posted13 Sep 2010 (estimated)
Study startJan 2010
Primary completionApr 2010
Study completionApr 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.
Other trials for Healthy SubjectsStudies 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01199965
Sponsor's protocol ID: MAP0004-CL-P203
Status last verified: Dec 2013
First submitted: 5 Aug 2010
Last updated: 9 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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: An Open-Label, 2-Period, Crossover Phase 2 Study Comparing the Pharmacokinetics and Tolerability of Dihydroergotamine Mesylate (DHE) Delivered Intravenously (DHE 45) and by Oral Inhalation (MAP0004) in Smoking and Non-Smoking Adult Volunteers
ClinicalTrials.gov ID: NCT01199965
Acronym / sponsor ID: MAP0004-CL-P203
Conditions: Healthy Subjects
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Collaborators: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Study start: Jan 2010
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 13 Sep 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 pharmacokinetics of Dihydroergotamine Mesylate (DHE) delivered by oral inhalation (MAP0004) or Intravenous (IV) DHE in smokers versus non-smokers.

Identify whether there are clinically significant differences in the tolerability of MAP0004 between smokers and non-smokers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
IV DHE then MAP0004	Other	Drug: MAP0004, Drug: IV DHESmokers and non-smokers received Intravenous Dihydroergotamine Mesylate (IV DHE) at Visit 2 followed by MAP0004 7-11 days later at Visit 3.
MAP0004 then IV DHE	Other	Drug: MAP0004, Drug: IV DHESmokers and non-smokers received MAP0004 at Visit 2 followed by Intravenous Dihydroergotamine Mesylate (IV DHE) 7-11 days later at Visit 3.

Who may qualify

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

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
MAP00041.0mg MAP0004 via inhalation at Visit 2 or 3 as per protocol	Drug	IV DHE then MAP0004, MAP0004 then IV DHE
IV DHEAlso: D.H.E.45®IV DHE administered at Visit 2 or 3 as per protocol	Drug	IV DHE then MAP0004, MAP0004 then IV DHE

Primary outcome

Cmax of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers Versus Non-smokers
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 and IV DHE Administration in Smokers and Non-smokers
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).

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
Smokers	23	22
Non-smokers	24	24

Primary outcome: Cmax of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers Versus Non-smokers

Time frame: 48 hours. Geometric mean (Standard Deviation). Unit: pg/ml

Measure	MAP0004 1.0mg Smokers n = 22	MAP0004 1.0mg Non-smokers n = 24	IV DHE 1.0mg Smokers n = 22	IV DHE 1.0mg Non-smokers n = 24
Value	1282.059 (636.138)	2550.727 (1297.097)	60046.128 (49580.385)	48428.635 (43894.253)

Population analysed: Patients with available data at specified time points are included in the analysis population.

Primary outcome: AUC(0-48) of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers and Non-smokers

Time frame: 48 hours. Geometric mean (Standard Deviation). Unit: pg*h/ml

Measure	MAP0004 1.0mg Smokers n = 23	MAP0004 1.0mg Non-smokers n = 24	IV DHE 1.0mg Smokers n = 22	IV DHE 1.0mg Non-smokers n = 24
Value	3014.968 (1136.162)	4148.750 (1533.861)	11049.027 (3744.094)	11731.639 (3167.828)

Population analysed: Patients with available data at specified time points are included in the analysis population.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MAP0004 1.0mg Smokers	0 of 23 (0%)	4 of 23 (17.4%)	Not reported
MAP0004 1.0mg Non-smokers	0 of 24 (0%)	8 of 24 (33.3%)	Not reported
IV DHE 1.0mg Smokers	0 of 22 (0%)	15 of 22 (68.2%)	Not reported
IV DHE 1.0mg Non-smokers	0 of 24 (0%)	22 of 24 (91.7%)	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.

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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 1/2 study testing MAP0004 and IV DHE in people with Healthy Subjects, run by Allergan at 1 site in United Kingdom.

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

Who may be eligible to take part?

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 Kingdom. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Cmax of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers Versus Non-smokers (time frame: 48 hours). 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 NCT01199965.

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.