A Phase 1b/2a, Randomized, Multi-center, Open-label, Fixed-sequence Study to Evaluate the Effect of Oral SYN-004 on the Pharmacokinetics of Intravenous Ceftriaxone in Healthy Adult Subjects With a Functioning Ileostomy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 主要终点
- Ceftriaxone PK Time to Reach Cmax (Tmax) With (Period 2) and Without (Period 1) SYN-004.
研究概览
简要总结
A Phase 1b/2a, Randomized, Multi-Center, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Oral SYN-004 on the Pharmacokinetics of Intravenous Ceftriaxone in Healthy Adult Subjects with a Functioning Ileostomy.
详细描述
This is a Phase 1b/2a, randomized, multi-center, open-label study. Twenty otherwise healthy subjects between the ages of 18 and 80 years, inclusive, with functioning ileostomies were planned to be enrolled. In the first treatment period (Period 1) all subjects received an IV infusion of 1 g ceftriaxone. Subjects had a 3 - 7 day washout period between Period 1 and Period 2. In the second treatment period (Period 2) all subjects received an IV infusion of 1 g ceftriaxone and 2 oral doses of either 75 or 150 mg of SYN-004, according to the randomization schedule, which were administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject has a functioning ileostomy which has been in place for > 3 months.
- •Male or female between the ages of 18 and 70 years, inclusive.
- •Other than a functioning ileostomy, the subject is free from clinically significant illnesses or disease.
排除标准
- •Subjects who have active hepatic, small intestine, or biliary tract disease.
- •Subjects who have active ulcerative colitis, Crohn's disease, other inflammatory bowel disease.
- •Subjects with known malignancy requiring treatment < 6 months prior to study screening.
- •Subjects who have, in the opinion of the investigator, significant concurrent medical illness.
- •Subjects who are currently taking concomitant medications which may interfere with study evaluation.
- •Subjects who have received an investigational drug within 30 days or within a time period consistent with a washout period of 5 half-lives, whichever is longer, of the first dose of ceftriaxone.
- •Subjects with a known history of allergy to any cephalosporin, penicillin or any β-lactam antibiotic.
- •Subjects who have known active malabsorption syndromes(s) that, in the judgment of the investigator, could compromise the objectives of the study.
- •Subjects who have used any oral, intramuscular, or IV anti-microbial medication during the last 3 weeks prior to the screening visit.
研究组 & 干预措施
Period 1 - Treatment Sequence AB
Treatment Sequence AB:
- Period 1: Ceftriaxone 1 g infused IV over 30 minutes
- [Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg (1 x 75 mg capsule) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion]
干预措施: Period 1 - Treatment Sequence AB (Drug)
Period 1 - Treatment Sequence AC
- Period 1: Ceftriaxone 1 g infused IV over 30 minutes
- [Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg (2 x 75 mg capsules) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion]
干预措施: Period 1 - Treatment Sequence AC (Drug)
Period 2 - Treatment Sequence AB
Treatment Sequence AB:
- [Period 1: Ceftriaxone 1 g infused IV over 30 minutes]
- Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg (1 x 75 mg capsule) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
干预措施: Period 2 - Treatment Sequence AB (Drug)
Period 2 - Treatment Sequence AC
- [Period 1: Ceftriaxone 1 g infused IV over 30 minutes]
- Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg (2 x 75 mg capsules) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
干预措施: Period 2 - Treatment Sequence AC (Drug)
结局指标
主要结局
Ceftriaxone PK Time to Reach Cmax (Tmax) With (Period 2) and Without (Period 1) SYN-004.
时间窗: 2 weeks
Samples were collected at 0.25 h, 0.5 through 2 h, and 3 through 7 h after the infusion start. Standard deviations may be 0 if all collected T max values occur at the same time.
Ceftriaxone PK Maximum Observed Plasma Concentration (Cmax) With (Period 2) and Without (Period 1) SYN-004.
时间窗: 2 weeks
Ceftriaxone PK Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUCt) With (Period 2) and Without (Period 1) SYN-004.
时间窗: 2 weeks
次要结局
未报告次要终点