Adults 18 to 65, any sex, with Migraine. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Adverse Events (AEs) (Part I)Primary· Up 14 days after the last dose of telcagepant and/or [11C]MK-4232 in Part I of study (Up to approximately 14 weeks)
Any AEs occurring among participants (all were healthy subjects) in Part I of study were recorded. An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the administration of the study drug, was also an AE.
Group
Value
95% CI
Telcagepant and [11C]MK-4232 (Part I): Healthy Participants
4
Number of Participants With AEs (Part III)Primary· Up 14 days after the last dose of telcagepant and/or [11C]MK-4232 in Part III of study (Up to approximately 6 months)
Any AEs occurring among participants (all were migraine patients) in Part III of study were recorded. An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the administration of the study drug, was also an AE.
Group
Value
95% CI
Telcagepant and [11C]MK-4232 (Part III): Migraineurs
4
Brain Calcitonin Gene-related Peptide (CGRP) Receptor Occupancy (RO) Post Telcagepant Obtained by PET Imaging Using [11C]MK-4232 Tracer at Baseline and After a Maximum Dose of Telcagepant (1120 mg) in Healthy Participants (Part I, Period 1)Primary· Part I Baseline, at ~0-90 minutes after [11C]MK-4232 dose; and Part I, Period 1 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose
Brain CGRP RO post telcagepant was determined by change in \[11C\]MK-4232 PET tracer biokinetics at baseline and post telcagepant administration. Using PET brain images acquired over \~0-90 minutes after \[11C\]MK-4232 dose, regions of interest (ROIs) were drawn throughout cerebral cortex and white matter, striatum, thalamus, cerebellum and pons. The ROIs were projected onto all frames of the dynamic PET scans in order to generate \[11C\]MK-4232 tissue time-activity curves (TACs). Serial arterial blood samples for measurement of plasma radioactivity and \[11C\]MK-4232 concentrations were colle
Subject 04
Group
Value
95% CI
Telcagepant and [11C]MK-4232 (Part I): Healthy Participants
43
Subject 01
Group
Value
95% CI
Telcagepant and [11C]MK-4232 (Part I): Healthy Participants
48
Subject 103
Group
Value
95% CI
Telcagepant and [11C]MK-4232 (Part I): Healthy Participants
58
Average Telcagepant Plasma Concentration During PET Imaging Using [11C]MK-4232 Tracer After a Maximum Dose of Telcagepant (1120 mg) in Healthy Participants (Part I, Period 1)Primary· Part I, Period 1 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose
In Part I, Period 1 blood samples for determination of plasma telcagepant concentrations were obtained prior to the telcagepant dose (time 0) and at 2, 3, 4 and 5 hours post telcagepant dose. The average plasma telcagepant concentration during the PET scan was determined, calculated as the area under the plasma telcagepant concentration versus time curve during the PET scanning interval divided by the duration of the PET scanning interval.
Subject 04
Group
Value
95% CI
Telcagepant and [11C]MK-4232 (Part I): Healthy Participants
16.3
± 1.84
Subject 01
Group
Value
95% CI
Telcagepant and [11C]MK-4232 (Part I): Healthy Participants
20.2
± 3.93
Subject 103
Group
Value
95% CI
Telcagepant and [11C]MK-4232 (Part I): Healthy Participants
22.2
± 4.43
Brain CGRP RO Post Telcagepant Obtained by PET Imaging Using [11C]MK-4232 Tracer at Baseline and After a Therapeutic Dose of Telcagepant (140 mg) in Healthy Participants (Part I, Period 2)Primary· Part I Baseline, at ~0-90 minutes after [11C]MK-4232 dose; and Part I, Period 2 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose
Brain CGRP RO post telcagepant was determined by change in \[11C\]MK-4232 PET tracer biokinetics at baseline and post telcagepant administration. Using PET brain images acquired over \~0-90 miniutes after \[11C\]MK-4232 dose, ROIs were drawn throughout the cerebral cortex and white matter, striatum, thalamus, cerebellum and pons. The ROIs were projected onto all frames of the dynamic PET scans in order to generate \[11C\]MK-4232 tissue TACs. Serial arterial blood samples for measurement of plasma radioactivity and \[11C\]MK-4232 concentrations were collected during the PET scans. These samples
Subject 02
Group
Value
95% CI
Telcagepant and [11C]MK-4232 (Part I): Healthy Participants
5
Subject 04
Group
Value
95% CI
Telcagepant and [11C]MK-4232 (Part I): Healthy Participants
10
Subject 101
Group
Value
95% CI
Telcagepant and [11C]MK-4232 (Part I): Healthy Participants
4
Average Telcagepant Plasma Concentration During PET Imaging Using [11C]MK-4232 Tracer After a Therapeutic Dose of Telcagepant (140 mg) in Healthy Participants (Part I, Period 2)Primary· Part 1, Period 2 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose
In Part I, Period 2 blood samples for determination of plasma telcagepant concentrations were obtained prior to the telcagepant dose (time 0) and at 1, 2, 3 and 4 hours post telcagepant dose. The average plasma telcagepant concentration during the PET scan was determined, calculated as the area under the plasma telcagepant concentration versus time curve during the PET scanning interval divided by the duration of the PET scanning interval.
Subject 02
Group
Value
95% CI
Telcagepant and [11C]MK-4232 (Part I): Healthy Participants
0.254
± 0.140
Subject 04
Group
Value
95% CI
Telcagepant and [11C]MK-4232 (Part I): Healthy Participants
0.859
± 0.305
Subject 101
Group
Value
95% CI
Telcagepant and [11C]MK-4232 (Part I): Healthy Participants
0.424
± 0.187
Adverse events — posted to ClinicalTrials.gov
Time frame: Up 14 days after the last dose of telcagepant and/or [11C]MK-4232 (Up to approximately 14 weeks for Part I, Up to approximately 6 months for Part III).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Telcagepant and [11C]MK-4232 (Part I): Healthy Participants
Serious: 0/6 (0%)
Deaths: —
Telcagepant and [11C]MK-4232 (Part III): Migraineurs
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 2 April 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01315847.