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Completed

NCT Number: NCT01085123

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

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

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Key information

Conditions

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

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapimelt

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.

Other names: ZOMIG®

[11C]AZ10419369

Drug

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 11, 2010
Registry last updated
Nov 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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