HealthyPhase 1NCT01468558
Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole
A Phase 1 study testing MAP0004, IV DHE and Ketoconazole in people with Healthy, run by Allergan at 1 site in United Kingdom.
Trial summary
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… 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, IV DHE and Ketoconazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2010to Aug 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
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Simbec Research Limited
Merthyr Tydfil, Merthyr Tydfil
About this study
Official 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®)
Compare the DHE pharmacokinetic profiles observed following administration of:
- MAP0004 (oral inhalation DHE)
- MAP0004 co-administered with oral Ketoconazole
- 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.
- Conditions
- Healthy
- Being tested
- MAP0004, IV DHE, Ketoconazole
- Keywords
- Drug Drug Interaction Study in Normal Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAP0004Drug
MAP0004 1.0mg via inhalation on Day 1 and Day 6 of Visit 2
IV DHEDrug
Also called D.H.E.45®
IV DHE (Intravenous Dihydroergotamine Mesylate) administered at Visit 3
KetoconazoleDrug
Also called Nizoral®
Ketoconazole 400 mg administered once a day on days 3-6 of Visit 2
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Other | Subjects received MAP0004 on Day 1 of Visit 2, Ketoconazole on Days 3 through 6 of Visit 2, and MAP0004 again on Day 6 of Visit 2. Subjects then returned for Visit 3, 7-11 days from the end of Visit 2. At Visit 3 subjects received 1.0 mg IV DHE (Intravenous Dihydroergotamine Mesylate). Receives: Drug: MAP0004; Drug: IV DHE; Drug: Ketoconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration
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, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration
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.
- First posted9 Nov 2011 (estimated)
- Study startJul 2010
- Primary completionAug 2010
- Study completionAug 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468558
- Sponsor's protocol ID
- MAP0004-CL-P104
- Status last verified
- Dec 2013
- First submitted
- 28 Oct 2011
- Last updated
- 9 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kellerman D, Kori S, Forst A, Chang J, Febbraro S, Wutann L, Thomas T, Taylor G, Dodick D. Lack of drug interaction between the migraine drug MAP0004 (orally inhaled dihydroergotamine) and a CYP3A4 inhibitor in humans. Cephalalgia. 2012 Jan;32(2):150-8. doi: 10.1177/0333102411432299. Epub 2011 Dec 15.
PubMed 22174351
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 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®)
- ClinicalTrials.gov ID
- NCT01468558
- Acronym / sponsor ID
- MAP0004-CL-P104
- Conditions
- Healthy
- Keywords
- Drug Drug Interaction Study in Normal Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Collaborators
- MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
- Study start
- Jul 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 9 Nov 2011 (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 DHE pharmacokinetic profiles observed following administration of:
- MAP0004 (oral inhalation DHE)
- MAP0004 co-administered with oral Ketoconazole
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Other | Drug: MAP0004, Drug: IV DHE, Drug: KetoconazoleSubjects received MAP0004 on Day 1 of Visit 2, Ketoconazole on Days 3 through 6 of Visit 2, and MAP0004 again on Day 6 of Visit 2. Subjects then returned for Visit 3, 7-11 days from the end of Visit 2. At Visit 3 subjects received 1.0 mg IV DHE (Intravenous Dihydroergotamine Mesylate). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| MAP0004MAP0004 1.0mg via inhalation on Day 1 and Day 6 of Visit 2 | Drug | All subjects |
| IV DHEAlso: D.H.E.45®IV DHE (Intravenous Dihydroergotamine Mesylate) administered at Visit 3 | Drug | All subjects |
| KetoconazoleAlso: Nizoral®Ketoconazole 400 mg administered once a day on days 3-6 of Visit 2 | Drug | All subjects |
Primary outcome
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).
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).
Results and safety
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 22174351Kellerman D, Kori S, Forst A, Chang J, Febbraro S, Wutann L, Thomas T, Taylor G, Dodick D. Lack of drug interaction between the migraine drug MAP0004 (orally inhaled dihydroergotamine) and a CYP3A4 inhibitor in humans. Cephalalgia. 2012 Jan;32(2):150-8. doi: 10.1177/0333102411432299. Epub 2011 Dec 15.
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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, IV DHE and Ketoconazole in people with Healthy, 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?
The sponsor lists 0 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 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 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?
Cmax of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration (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 NCT01468558, 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.