A study of the effects of single doses of MK-1167 on neurotransmitter cycling in the brain of healthy adult participants using 13C-Magnetic Resonance Spectroscopy.
- Conditions
- Alzheimer's Dementia10012272
- Registration Number
- NL-OMON51348
- Lead Sponsor
- Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
Body Mass Index (BMI) between >= 18 and <=30 kg/m2, inclusive
Be judged to be in good health based on medical history, physical and
neurological examination, VS measures, ECGs and laboratory safety tests
obtained at the screening visit.
Participants should be male, from 18 years to 60 years of age inclusive at the
time of providing informed consent.
History of clinical signifiant endocrine, GI, cardiovasculair, hematological,
hepatic, immunological, renal, respiratory, genitourinary, or major
neurological (including stroke and chronic seizures) abnormalities or diseases.
Participants with a remote history of uncomplicated medical events (eg,
uncomplicated kidney stones, as defined as spontaneous passage and no
recurrence in the last 5 years, or childhood asthma) may be enrolled in the
study at the discretion of the investigator.
Mentally or legally incapacitated, has significant emotional problems at the
time of screening visit or expected during the conduct of the study or has a
history of clinically significant psychiatric disorder in the last 5 years.
Participants who have had situational depression may be enrolled in the study
at the discretion of the investigator.
Further criteria apply, see protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Objective: To evaluate the effect of single oral doses of MK-1167 on glutamate<br /><br>metabolism in the prefrontal cortex using sel POCE 13C-MRS<br /><br>Hypothesis: The mean fractional enrichment (FE) of glutamate increases above<br /><br>baseline levels for at least one dose level of MK-1167</p><br>
- Secondary Outcome Measures
Name Time Method <p>Objective: To evaluate the effect of single oral doses of MK-1167 on glutamine<br /><br>metabolism in the prefrontal cortex using sel POCE 13C-MRS<br /><br>Hypothesis: The mean FE of glutamine increases above baseline levels for at<br /><br>least one dose level of MK-1167<br /><br><br /><br>To evaluate the safety of single doses of MK-1167 in healthy adult participants</p><br>