NL-OMON50904已完成不适用
A Randomized, double-blind Crossover Trial to Investigate the Effects of Oliceridine and Morphine on Ventilatory Drive and Pain Relief in Healthy Elderly Subjects * a population pharmacokinetic/pharmacodynamic modeling study - Oliceridine PKPD in the elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
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
- •- Absence of any significant medical, neurologic, or psychiatric illness as
- •determined by the investigators.
- •- Age 55 yr or older;
- •- Body mass index (BMI) of 19 - 35 kg/m2. The BMI range is relatively large to
- •obtain a representative sample of individuals in the population.
- •- Willingness and competence to sign written informed consent.
- •- Screening cold pressor test hand removal latencies of > 20 and < 120 seconds.
排除标准
- •1. Clinically significant medical, surgical, psychiatric or substance abuse
- •condition or history of such condition that would confound the interpretation
- •of data in the study.
- •2. Clinically significant, immune mediated hypersensitivity reaction or
- •intolerance to opioids.
- •3. Exposure to opioids or anesthesia within 30 days before the first treatment
- •period of the study.
- •4. Caffeine within 24 hours before the first treatment period of the study.
- •5. Positive urine drug screen or alcohol breathalyzer test at the screening
- •visit or positive urine dipstick for substances of abuse or alcohol breath test
- •at each visit.
- •6. Participation in a previous oliceridine clinical study.
- •7. Participation in another interventional clinical study within 30 days before
- •the first treatment period of the study.
- •8. Weight < 50 kg.
- •9. Body mass index outside the range of 18 * 35 kg/m2, inclusive.
- •10. Cytochrome P450 (CYP450) 2D6 poor metabolizer (PM) status or indeterminate
- •results for 2D6 genotype and/or phenotype.
- •11. Any clinically significant clinical laboratory abnormality, including total
- •bilirubin > 2 × upper limit of normal [ULN] or elevated hepatic transaminases
- •(aspartate aminotransferase [AST] > 1.5 × ULN OR alanine aminotransferase [ALT]
- •> 1.5 × ULN).
- •12. Clinically significant abnormality on electrocardiogram, including a QT
- •interval corrected for heart rate (QTcF interval) of > 450 milliseconds, at the
- •screening visit.
- •13. Clinically significant, immune mediated hypersensitivity reaction or
- •intolerance to 5-HT3 inhibitors.
- •14. Unsuitable screening HCVR test results (e.g., ability to tolerate the mask,
- •breathe in a regular fashion, increase ventilation in response to increases in
- •inhaled CO2), as judged by the investigator
- •15. A high risk of obstructive sleep apnea as determined by the STOP-BANG
- •questionnaire (score greater than 4);
- •16. Alcohol intake of more than 4 units/day or more than 28 units/week;
- •17. The short version of the Mini Mental State Examination with a score less
- •than 8. The latter exclusion criterion was to prevent that subjects with some
- •form of cognitive impairment participated.
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