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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.

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. - MK-1167 Effect on Neurotransmitter Cycling in Healthy Participants

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51348
Enrollment
48
Registered
2022-06-22
Start date
2022-08-31
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Dementia

Interventions

Not applicable.

Sponsors

Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Inc.
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Body Mass Index (BMI) between >= 18 and

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Objective: To evaluate the effect of single oral doses of MK-1167 on glutamate metabolism in the prefrontal cortex using sel POCE 13C-MRS Hypothesis: The mean fractional enrichment (FE) of glutamate increases above baseline levels for at least one dose level of MK-1167

Secondary

MeasureTime frame
Objective: To evaluate the effect of single oral doses of MK-1167 on glutamine metabolism in the prefrontal cortex using sel POCE 13C-MRS Hypothesis: The mean FE of glutamine increases above baseline levels for at least one dose level of MK-1167 To evaluate the safety of single doses of MK-1167 in healthy adult participants

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)