MedDataX Logo

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

NCT ID: NCT01085123

Last Updated: 2010-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Migraine

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Migraine ZOMIG® Rapimelt

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

PET 1: baseline, PET 2: 10 mg Zomig® Rapimelt, PET 3: 5 mg ZOMIG® Rapimelt, PET 4 2.5 mg ZOMIG® Rapimelt

Group Type EXPERIMENTAL

Rapimelt

Intervention Type DRUG

oral tablet , 2.5 and 5 mg, single dose. 10 mg (2x5 mg) visit 3, 5 mg visit 4, 2.5 mg visit 5.

[11C]AZ10419369

Intervention Type DRUG

solution for iv injection. Will be injected within 2 to 5 hours after administration of ZOMIG® Rapimelt

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

[11C]AZ10419369

solution for iv injection. Will be injected within 2 to 5 hours after administration of ZOMIG® Rapimelt

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ZOMIG®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

AstraZeneca

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stephen Kanes

Role: STUDY_DIRECTOR

AstraZeneca

Wolfgang Kühn

Role: PRINCIPAL_INVESTIGATOR

Quintiles AB Phase I Services

Brendan Smyth

Role: STUDY_CHAIR

AstraZeneca

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Uppsala, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D1220C00005

Identifier Type: -

Identifier Source: org_study_id