Determine Central 5-HT1B Receptor Occupancy of ZOMIG® Rapimelt (Zolmitriptan) in Healthy Male Volunteers - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01085123

Purpose

The purpose of this study is to determine the central 5-HT1B receptor occupancy of ZOMIG® Rapimelt (zolmitriptan) in healthy male volunteers.

Condition	Intervention	Phase
Migraine	Drug: Rapimelt Drug: [11C]AZ10419369	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	An Open Label, Positron Emission Tomography (PET) Study With [11C]AZ10419369 to Determine Central 5-HT1B Receptor Occupancy of ZOMIG® Rapimelt (Zolmitriptan) in Healthy Male Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Migraine

Drug Information available for: Serotonin Zolmitriptan

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To determine zolmitriptan and/or its active metabolite 183C91 occupancy at 5-HT1B receptors in the living human brain [ Time Frame: The first PET measurement will serve as a baseline assessment. The second, third and fourth PET measurements will be performed after oral administration of ZOMIG® Rapimelt (10 mg, 5 mg and 2.5 mg, respectively). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To describe the relation between Zomig® Rapimelt dose and 5-HT1B receptor occupancy [ Time Frame: The second, third and fourth PET measurements will be performed after oral administration of ZOMIG® Rapimelt (10 mg, 5 mg and 2.5 mg, respectively). Imaging data analysis will be performed after each PET measurement ] [ Designated as safety issue: No ]
To describe the relation between plasma concentrations of zolmitriptan and 183C91 and 5-HT1B receptor occupancy [ Time Frame: For each of 3 visits venous blood for zolmitriptan and 183C91 PK analyses taken before drug administration and at 3 time points during PET examination: start, middle and end, ie, at 0, +30 and + 63 minutes relative to injection of the radioli ] [ Designated as safety issue: No ]

Enrollment:	10
Study Start Date:	May 2010
Study Completion Date:	October 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 PET 1: baseline, PET 2: 10 mg Zomig® Rapimelt, PET 3: 5 mg ZOMIG® Rapimelt, PET 4 2.5 mg ZOMIG® Rapimelt	Drug: Rapimelt oral tablet , 2.5 and 5 mg, single dose. 10 mg (2x5 mg) visit 3, 5 mg visit 4, 2.5 mg visit 5. Other Name: ZOMIG® Drug: [11C]AZ10419369 solution for iv injection. Will be injected within 2 to 5 hours after administration of ZOMIG® Rapimelt

Eligibility

Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Body mass index between ≥19 and ≤30 kg/m2.

Exclusion Criteria:

A history or presence of neurological, haematological, psychiatric, gastrointestinal, hepatic, pulmonary, renal disease
Use of drugs that induce the liver drug metabolising enzymes within 4 weeks before first PET

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085123

Locations

Sweden
Research Site
Uppsala, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Stephen Kanes	AstraZeneca
Principal Investigator:	Wolfgang Kühn	Quintiles AB Phase I Services
Study Chair:	Brendan Smyth	AstraZeneca

More Information

No publications provided

Responsible Party:	MSD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT01085123 History of Changes
Other Study ID Numbers:	D1220C00005
Study First Received:	March 10, 2010
Last Updated:	November 2, 2010
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:

Migraine
ZOMIG® Rapimelt

Additional relevant MeSH terms:

Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Zolmitriptan

Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2012