Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01085123
First received: March 10, 2010
Last updated: November 2, 2010
Last verified: November 2010

March 10, 2010
November 2, 2010
May 2010
October 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01085123 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Determine Central 5-HT1B Receptor Occupancy of ZOMIG® Rapimelt (Zolmitriptan) in Healthy Male Volunteers
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

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Migraine
  • 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
Experimental: 1
PET 1: baseline, PET 2: 10 mg Zomig® Rapimelt, PET 3: 5 mg ZOMIG® Rapimelt, PET 4 2.5 mg ZOMIG® Rapimelt
Interventions:
  • Drug: Rapimelt
  • Drug: [11C]AZ10419369
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01085123
D1220C00005
No
MSD, AstraZeneca
AstraZeneca
Not Provided
Study Director: Stephen Kanes AstraZeneca
Principal Investigator: Wolfgang Kühn Quintiles AB Phase I Services
Study Chair: Brendan Smyth AstraZeneca
AstraZeneca
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP