A Phase 1 Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of Study Drug
研究概览
简要总结
The primary purpose of this study is to evaluate the pharmacokinetics (PK) of SPR720, azithromycin, and ethambutol, administered separately and co-administered, in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) between ≥18.0 and ≤32.0 kilograms per meter square (kg/m^2) and weight between 50.0 and 100.0 kilograms (kg) (inclusive) at the Screening visit.
- •Medically healthy without clinically significant medical history, abnormalities in physical examination, laboratory tests, vital signs, or electrocardiogram (ECG) at the Screening visit.
- •Has suitable venous access for repeated blood sampling.
- •Has ability and willingness to abstain from alcohol, caffeine, xanthine-containing beverages or food (coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) or products containing any of these from 48 hours prior to study drug administration until discharge from the clinical research unit (CRU).
排除标准
- •Has a history of clinically significant acute illness or surgery within the previous 3 months prior to Screening Visit or Day -
- •Has a known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication.
- •Has any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract [including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas]). History of uncomplicated appendectomy ≥1 year prior to Screening Visit would not be considered exclusionary at the discretion of the Investigator.
- •Is unable to swallow the dosage forms.
- •Has received any other investigational medicinal product or participation in another investigational clinical study that included drug treatment within 30 days prior to Day 1 dose (based on the timing of the last Follow-up Visit for the previous study to Day 1 of the current study).
- •[Note: Other inclusion and exclusion criteria as per protocol may apply.]
研究组 & 干预措施
SPR720 1000 mg
Healthy participants will receive SPR720 1000 milligrams (mg), orally, once daily (QD) for 7 days.
干预措施: SPR720 (Drug)
Azithromycin 500 mg
Healthy participants will receive azithromycin 500 mg, orally, QD for 7 days.
干预措施: Azithromycin (Drug)
Ethambutol 800 mg
Healthy participants will receive ethambutol 800 mg, orally, QD for 7 days.
干预措施: Ethambutol (Drug)
SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg
Healthy participants will be co-administered SPR720 1000 mg, azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days.
干预措施: SPR720 (Drug)
SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg
Healthy participants will be co-administered SPR720 1000 mg, azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days.
干预措施: Azithromycin (Drug)
SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg
Healthy participants will be co-administered SPR720 1000 mg, azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days.
干预措施: Ethambutol (Drug)
Azithromycin 500 mg + Ethambutol 800 mg
Healthy participants will be co-administered azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days.
干预措施: Azithromycin (Drug)
Azithromycin 500 mg + Ethambutol 800 mg
Healthy participants will be co-administered azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days.
干预措施: Ethambutol (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of Study Drug
时间窗: Pre-dose and at multiple time points post-dose up to Day 8
Area Under the Concentration-time Curve From Time Zero to Dosing Interval (AUC0-τ) for Study Drug
时间窗: Pre-dose and at multiple time points post-dose up to Day 8
Time to Attain Maximum Plasma Concentration (tmax) for Study Drug
时间窗: Pre-dose and at multiple time points post-dose up to Day 8
次要结局
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(From the first dose of study drug through follow-up Day 13)