NL-OMON32792已完成不适用
A randomized, single center, 2-way crossover, comparator controlled Phase I trial to evaluate the effect of a new analgesic on ventilation in healthy subjects - A study to investigate the effect of GRT6005 on ventilation.
Grunenthal0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
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 99（—）
入选标准
- •1. White male subjects aged 18 years to 45 years inclusive.
- •2. Body mass index between 20 kg/m2 and 28 kg/m2 inclusive, with a body weight of not less than 50 kg.
- •3. Subjects must be in good health as determined by medical history, physical examination, 12-lead ECG, oxygen saturation, vital signs, and clinical laboratory parameters.
- •4. Subjects willing to use barrier contraception (condom) during sexual intercourse with women, and no sexual intercourse with women who are pregnant or lactating is allowed from dosing of GRT6005 until 1 month after the Final Examination. Subjects willing to ensure that their female sexual partner uses medically acceptable contraception during this time frame (e.g., oral contraceptive).
- •5. Subjects giving written informed consent to participate in the trial.
排除标准
- •1. Resting pulse rate is <45 bpm or >100 bpm after 5 min rest in semi-recumbent position.
- •2. Resting blood pressure after 5 min rest in semi-recumbent position:
- •a. Systolic blood pressure is <100 mmHg or >150 mmHg.
- •b. Diastolic blood pressure is <50 mmHg or >90 mmHg.
- •3. History of orthostatic hypotension. Standardization of trial population and safety.
- •4. Positive or missing test for human immunodeficiency virus antibodies (Type 1 and Type 2), hepatitis B surface antigens, hepatitis B core antigen antibodies, or hepatitis C virus antibodies.
- •5. Participation in another clinical trial within 90 days prior to enrollment into this trial.
- •6. Positive or missing drugs of abuse screening (alcohol breath test, urine screening test for drugs of abuse).
- •7. Diseases or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- •8. Marked repolarization abnormality (e.g., suspected or definite congenital long QT syndrome with QT and/or QTcB >500 ms or prolonged QTcB, i.e., >450 ms).
- •9. Bronchial asthma or other respiratory diseases.
- •10. Definite or suspected history of drug allergy or hypersensitivity.
- •11. Regular use of any medication at the time of enrollment and anticipated further use until first administration of IMP.
- •12. History of alcohol or drug abuse.
- •13. History of neurotic personality, psychiatric illness, or suicide risk.
- •14. Not able to abstain from consumption of:
- •a. Beverages or food containing caffeine (tea, coffee, cola, chocolate, etc.) from 48 h prior to each dosing until discharge from the ward.
- •b. Beverages or food containing quinine (bitter lemon, tonic water) from 2 weeks before dosing and during the whole trial.
- •c. Grapefruit juice (sweet or sour) or alcohol from 48 h prior to each dosing until discharge from the ward.
- •d. Poppy seed-containing beverages or food, from 72 h prior to enrollment and each dosing.
- •15. Blood loss of 500 mL within 3 months before enrollment into this trial, including blood donation.
- •16. History of or at risk of seizures (i.e., head trauma, epilepsy in family history, unclear loss of consciousness).
- •17. Known or suspected of not being able to comply with procedures described in the trial protocol.
- •18. Not able to communicate meaningfully with the Investigator
- •19. Smoking of >10 cigarettes/day or equivalent.
研究者
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