CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 10 enrolled
Drug / intervention
telcagepant +1 moredrug
Likely dose
telcagepant 1120 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01315847
NCT01315847Phase 1Completed
CompareCT.gov

A Three-Part Positron Emission Tomography Study of Brain CGRP Receptor Occupancy Levels Following Administration of MK-0974, Using [11C]MK-4232 as an Imaging Agent

Merck Sharp & Dohme LLC·interventional·Posted Mar 15, 2011·Updated Apr 2, 2019

In Brief

A Phase 1 clinical trial evaluating telcagepant and [11C]MK-4232 for Migraine. Completed, enrolled 10 participants.

Detailed Summary

The purpose of this study is to determine the receptor occupancy (RO) associated with telcagepant (MK-0974) administration based on displacement of \[11C\]MK-4232 from the CGRP receptors in the brain using PET. The study enrolled healthy participants (Part I) and migraine patients (Part III). Due to a protocol amendment, study Part II was not conducted.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 15, 2011
Enrollment StartJan 14, 2010
Primary CompletionJul 26, 2011
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.3 years ago

Interventions

telcagepantdrug

Single oral doses of telcagepant 1120 mg (Part I - Period 1) and 140 mg (Part I - Period 2; Part III - Period 1 and 2)

[11C]MK-4232drug

Single intravenous doses of \~300 MBq \[11C\]MK-4232 administered as a 5 minute infusion (Part I - Baseline, Period 1 and 2; Part III - Period 1 Baseline and Period 1, and Period 2 Baseline and Period 2)