Trials / Completed
CompletedNCT02621606
[11C]MK-6884 Positron Emission Tomography (PET) Tracer Validation Trial (MK-6884-001)
A Three-Part Trial to Qualify [11C]MK-6884 Positron Emission Tomography for Use as a Biomarker for Regional M4 PAM Receptor Density Quantification in the Human Brain
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this open-label, 3-part study is to investigate the safety and efficacy of \[11C\]MK-6884 as a positron emission tomography (PET) imaging agent for quantifying muscarinic 4 (M4) positive allosteric modulator (PAM) receptor density in brain regions of interest. The study will enroll healthy participants (Parts 1 and 2) and participants with Alzheimer's Disease (AD) (Part 3). The primary efficacy hypothesis is that the average intra-subject test-retest (T-RT) variability of tracer uptake in brain regions of interest is ≤20%.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | [11C]MK-6884 | IV bolus dose of \~370 MBq \[11C\]MK-6884 |
Timeline
- Start date
- 2016-01-08
- Primary completion
- 2017-12-28
- Completion
- 2017-12-28
- First posted
- 2015-12-03
- Last updated
- 2022-09-13
- Results posted
- 2019-02-28
Source: ClinicalTrials.gov record NCT02621606. Inclusion in this directory is not an endorsement.