NL-OMON56752尚未招募不适用
Open-label, randomised, 4 parallel-group, Phase I clinical trial to investigate BI 456906 occupancy of Glucagon receptors in liver and Glucagon-like Peptide 1 receptors in pancreas in comparison with semaglutide after administration of radiolabeled tracer in male and female subjects with obesity using PET and MRI - 1404-0047
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
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. Healthy male or female subjects according to the assessment of the
- •investigator, as based on a complete medical history including a physical
- •examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- •2. Age of 18 to 65 years (inclusive)
- •3. BMI of >=30 and <=40 kg/m2 and body weight >=70 kg and <=150 kg.
- •4. Signed and dated written informed consent prior to admission to the study,
- •in accordance with GCP and local legislation
- •5. Women of childbearing potential (WOCBP) 1 must be willing and able to use
- •two forms of effective contraception where at least one form is a highly
- •effective method of birth control per ICH M3 (R2) that result in a low failure
- •rate of less than 1% per year when used consistently and correctly. A list of
- •contraception methods meeting these criteria is provided in the subject
- •information (Section 4.2.2.3).
排除标准
- •Subjects will not be allowed to participate if any of the following general
- •criteria apply:
- •1. Any finding in the medical examination (including BP, PR or ECG) deviating
- •from normal and assessed as clinically relevant by the investigator
- •2. Resting heart rate >100 beats per minute (bpm) and/or systolic blood
- •pressure >=160 mmHg and/or diastolic blood pressure >=95 mmHg at screening
- •3. Any laboratory value outside the reference range that the investigator
- •considers to be of clinical relevance. Subjects with the following abnormal
- •values are not eligible for the trial participation:
- •- LDL >160 mg/dL (4.15 mmol/L)
- •- total cholesterol >240 mg/dL (6.22 mmol/L)
- •- triglyceride >200 mg/dL (2.26 mmol/L)
- •- blood glucose >126 mg/dl (7 mmol/L) fasting and/or HbA1c >6.5%
- •4. Any evidence of a concomitant disease assessed as clinically relevant by the
- •investigator. Subjects with type 1 and type 2 diabetes mellitus are not
- •eligible for the trial
- •5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
- •immunological or hormonal disorders assessed as clinically relevant by the
- •investigator
- •6. Diseases of the central nervous system (including but not limited to any
- •kind of seizures), and other relevant neurological or psychiatric disorders
- •7. History of relevant orthostatic hypotension, fainting spells, or blackouts
- •8. Personal or family history of medullary thyroid carcinoma or multiple
- •endocrine neoplasia syndrome type 2, manifest hypo- or hyperthyroidism at Visit
- •9. Calcitonin >=100 pg/mL (29.26 pmol/L) at screening
- •10. Any suicidal behaviour or history of major depressive disorder requiring
- •inpatient treatment or escalation of care in the past 2 years before
- •randomization, any suicidal ideation of type 4 or 5 in the C-SSRS in the past 3
- •months prior to Visit 1
- •11. Chronic or relevant acute infections
- •12. History of chronic or acute pancreatitis or elevation of serum
- •lipase/amylase >2x ULN
- •13. History of relevant allergy or hypersensitivity (including allergy to the
- •trial medication or its excipients) according to investigator's assessment
- •14. Use of prescription or over-the counter drugs within 30 days of planned
- •administration of trial medication that might reasonably influence the results
- •of the trial including drugs known to significantly prolong the QT/QTcF
- •interval; please refer to Section 4.2.2
- •15. Intake of an investigational drug in another clinical trial within 60 d of
- •planned administration of investigational drug in the current trial, or
- •concurrent participation in another clinical trial in which investigational
- •drug is administered
- •16. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day) and
- •inability to refrain from smoking on specified trial days
- •17. Ongoing chronic alcohol use or drug abuse other than the ones described in
- •Table 5.2.3: 2, that in the investigator*s opinion, makes the subject an
- •unreliable trial subject or unlikely to complete the trial
- •18. Blood donation of more than 500 mL within 30 d of planned administration of
- •trial medication or intended blood donation during the trial
- •19. Intention to perform excessive physical activities within one week prior to
- 另有 3 项未显示
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