A Phase I, Open-label, Randomised, Crossover Study in 3 Parallel Groups to Evaluate the Effect of Rifampicin, Ketoconazole, and Omeprazole on the Pharmacokinetics of Sativex in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pharmacokinetic analysis - Cmax of Sativex® alone and of Sativex® with concomitant administration of rifampicin, ketoconazole, and omeprazole
研究概览
简要总结
Study to assess the effect of rifampicin, ketoconazole and omeprazole on the pharmacokinetics of a single dose of Sativex and to evaluate the safety of Sativex when given in combination with these other drugs.
详细描述
An open-label, randomised, crossover, drug interaction study. Subjects were divided into three groups and within each group, subjects were randomised to one of two treatment sequences. Subjects received 4 sprays of Sativex alongside either doses of rifampicin, ketoconazole or omeprazole.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects between 18 and 45 years of age (inclusive).
- •Subjects body mass index was between 18-30 kg/m2 (inclusive) as calculated by: Weight (kg)/height (m2).
- •No clinically significant abnormal findings on the physical examination, ECG, medical history, or clinical laboratory results during screening.
- •Subjects were to, in the opinion of the investigator, have no clinically significant abnormal findings of renal and hepatic function as determined by serum creatinine, total bilirubin, and transaminase levels.
- •Subjects were to be non-users of tobacco products (minimum of 6 months prior to the start of the study).
- •Subjects were to have a negative screen for HIV I and II, HBsAg. and antibody to hepatitis C.
- •Subjects were to have a negative urine screen for alcohol, drugs of abuse (screening only), and cotinine.
- •Subjects were to use an appropriate barrier method of contraception (condom and spermicide) in addition to having their female partner use another form of barrier contraception (e.g. female condom or occlusive cap [diaphragm or cervical vault/caps] with spermicide) during the study and for 3 months following administration of the study drug.
- •Subjects were to be able to comply with the protocol and the restrictions and the assessments therein.
- •Subjects were to give voluntary written informed consent to participate in the trial.
排除标准
- •Subjects were not to have a history or presence of significant cardiovascular, pulmonary, hepatic, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- •Subjects were not to have any history or presence of family history of schizophrenia, other psychotic illness, severe personality disorder, depression, or other significant psychiatric disorder.
- •Subjects were not to have a postural drop of 20 mmHG or more in systolic blood pressure at screening.
- •Subjects were not to have participated in a previous clinical trial within 90 days prior to study initiation.
- •Subjects were not to have donated plasma within 90 days prior to study initiation.
- •Subjects were not to have donated blood within 90 days prior to study initiation.
- •Subjects were not to have had an abnormal diet or substantial changes in eating habits within 30 days prior to study initiation.
- •Subjects were not to have had treatment with any known enzyme-altering agents (barbiturates, phenothiazines, cimetidine etc.) within 30 days prior to or during the study.
- •Subjects were to have no history of known hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
- •Subjects were not to use any prescription medication within 14 days prior to or during the study.
- •Subjects were not to use any over-the-counter medication within 7 days prior to or during the study.
- •Subjects were not to have a history of alcohol or drug abuse within 2 years prior to the study (subjects with a history of previous use of cannabis were not excluded unless they had used cannabis or cannabinoid based medicine within 30 days prior to study drug administration or were unwilling to abstain for the duration of the study).
研究组 & 干预措施
Sequence 1A
Sativex and rifampicin
干预措施: Sativex and rifampicin (Drug)
Sequence 1B
Sativex and rifampicin
干预措施: Sativex and rifampicin (Drug)
Sequence 2C
Sativex and ketoconazole
干预措施: Sativex and ketoconazole (Drug)
Sequence 2D
Sativex and ketoconazole
干预措施: Sativex and ketoconazole (Drug)
Sequence 3E
Sativex and omeprazole
干预措施: Sativex and omeprazole (Drug)
Sequence 3F
Sativex and omeprazole
干预措施: Sativex and omeprazole (Drug)
结局指标
主要结局
Pharmacokinetic analysis - Cmax of Sativex® alone and of Sativex® with concomitant administration of rifampicin, ketoconazole, and omeprazole
时间窗: Up to Day 8
Pharmacokinetic analysis - AUC(0-inf) of Sativex® alone and of Sativex® with concomitant administration of rifampicin, ketoconazole, and omeprazole
时间窗: Up to Day 8
Pharmacokinetic analysis - AUC(0-t) of Sativex® alone and of Sativex® with concomitant administration of rifampicin, ketoconazole, and omeprazole
时间窗: Up to day 8
次要结局
- Adverse Events(Up to follow up, Day 14)