Determine Central 5-HT1B Receptor Occupancy of ZOMIG® Rapimelt (zolmitriptan) in Healthy Male Volunteers

Study identifier:D1220C00005

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

migraine

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Rapimelt, [11C]AZ10419369

Sex

Male

Actual Enrollment

Study type

Interventional

Age

20 Years - 45 Years

Date

Study Start Date: 01 May 2010

Primary Completion Date: 01 Oct 2010

Study Completion Date: 01 Oct 2010

Study design

Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Uppsala, Sweden

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

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1741&filename=CSR-D1220C00005.pdf
Download
CSR-D1220C00005.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

Quintiles Uppsala

+ 46 184311175

Investigators

Principal Investigator

Stephen Kanes

AstraZeneca