NCT01468558

Brief Summary

Compare the DHE pharmacokinetic profiles observed following administration of:

  1. 1.MAP0004 (oral inhalation DHE)
  2. 2.MAP0004 co-administered with oral Ketoconazole
  3. 3.Intravenous (IV) DHE (D.H.E.45®, the approved reference therapy)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
2 years until next milestone

Results Posted

Study results publicly available

October 22, 2013

Completed
Last Updated

January 9, 2014

Status Verified

December 1, 2013

Enrollment Period

1 month

First QC Date

October 28, 2011

Results QC Date

August 19, 2013

Last Update Submit

December 9, 2013

Conditions

Healthy

Keywords

Drug Drug Interaction Study in Normal Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    48 hours

Study Arms (1)

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).

Drug: MAP0004Drug: IV DHEDrug: Ketoconazole

Interventions

MAP0004DRUG

MAP0004 1.0mg via inhalation on Day 1 and Day 6 of Visit 2

All subjects
IV DHEDRUG

IV DHE (Intravenous Dihydroergotamine Mesylate) administered at Visit 3

Also known as: D.H.E.45®
All subjects
KetoconazoleDRUG

Ketoconazole 400 mg administered once a day on days 3-6 of Visit 2

Also known as: Nizoral®
All subjects

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simbec Research Limited

Merthyr Tydfil, Merthyr Tydfil, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 22174351DERIVED

MeSH Terms

Interventions

DihydroergotamineKetoconazole

Intervention Hierarchy (Ancestors)

ErgotaminesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPiperazinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
VP, Scientific Affairs
Organization
MAP Pharmaceuticals Inc., a wholly owned subsidiary of Allergan
dkellerman@mappharma.com
650-386-3100

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2011

First Posted

November 9, 2011

Study Start

July 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

January 9, 2014

Results First Posted

October 22, 2013

Record last verified: 2013-12

Locations

GB(1)