NL-OMON51033已完成不适用
An Investigation of the Test-Retest Variability of Measures of the Fractional Enrichment of Glutamate/Glutamine in Healthy Adults Measured Using Selective Proton Observed, Carbon Edited (selPOCE) MRS - Study of selPOCE MRS Measures of Glutamate Flux in Healthy Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Is in good health based on medical history, physical examination, VS
- •measurements and ECGs performed prior to randomization (referring to Appendix 9
- •of the protocol).
- •2. Is in good health based on laboratory safety tests obtained at the screening
- •visit (referring to Appendix 2 and 10 of the protocol).
- •3. Have a fasting blood glucose <=110 mg/dL and a Hb1Ac <= 6.1%.
- •4. Have a BMI <=30 kg/m2, inclusive.
- •5. Is male, from 18 years to 50 years of age inclusive, at the time of signing
- •the informed consent.
- •6. The participant provides written informed consent/assent for the study,
- •including for future biomedical research.
- •7. Has acceptable venous access.
- •8. Is willing to comply with the study restrictions.
排除标准
- •1. Has a history of clinically significant endocrine, gastrointestinal,
- •cardiovascular, hematological, hepatic, immunological, renal, respiratory,
- •genitourinary, or major neurological (including stroke and chronic seizures)
- •abnormalities or diseases.
- •Candidates with Type 1 or 2 diabetes are specifically excluded.
- •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.
- •2. Is mentally or legally incapacitated, has significant emotional problems at
- •the time of pre-study (screening) visit or expected during the conduct of the
- •study or has a history of clinically significant psychiatric disorder of the
- •last 5 years. Participants who have had situational depression may be enrolled
- •in the study at the discretion of the investigator.
- •3. Has a history of cancer (malignancy).
- •Exceptions include adequately treated non-melanomatous skin carcinoma or other
- •malignancies which have been successfully treated with appropriate follow up
- •and are therefore unlikely to recur for the duration of the study, in the
- •opinion of the investigator and with agreement of the Sponsor (eg, malignancies
- •which have been successfully treated >=10 years prior to the pre-study
- •[screening] visit).
- •4. Has a history of significant multiple and/or severe allergies (eg, food,
- •drug, latex allergy), or has had an anaphylactic reaction or significant
- •intolerability (ie, systemic allergic reaction) to prescription or
- •non-prescription drugs or food.
- •5. Is positive for hepatitis B surface antigen, hepatitis C antibodies or HIV.
- •17. Parts 2 and 3 only: Has implanted metal objects (including pacemakers,
- •neurostimulators, vascular clips, cochlear or other auditory implants,
- •hydrocephalus/insulin/medicine pumps, vascular stents, etc), works with metal
- •(ie, welder), or has any other exclusion criteria that prevents participation
- •in an MRI scan.
- •For complete overview see the protocol.
研究者
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