A Single/Repeat Dose Study With Three Oral Formulations of Firategrast (Immediate Release Tablet, Modified Release Tablet, and Naso-gastric Infusion) in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- PK measures for single and repeat dose
研究概览
简要总结
This study will investigate how 3 types of drug formulations are absorbed by the body. This study is termed 'open-label', which means volunteers will be aware of which treatment they are receiving. The study is split into 2 parts. Part 1, involves volunteers receiving 2 new formulations, as a single dose. There is no placebo (dummy-drug; no active ingredient) in this study. Volunteers will also receive a single dose of a formulation used in previous trials (reference formulation), so a proper comparison with the new formulations can be made. The new fomulations will be administered with food and the reference formulation will be given without food. In Part 2, volunteers will receive only one of the 3 formulations as a repeat dose for 7 days. Each of these doses will be given with food.
详细描述
The present study will be conducted in two parts in healthy male volunteers. Part 1 will investigate the pharmacokinetics and tolerability of single doses of firategrast administered as the existing immediate release tablet formulation, as a modified release tablet (3hr) formulation and as a simulated gastro-retentive formulation to be administered via a naso-gastric tube. Subjects will receive each formulation in a randomised 3-way single dose crossover fashion.
Part 2, based on the review of safety, tolerability and pharmacokinetic data from the first two study treatment periods of Part 1, will investigate the pharmacokinetics and tolerability of multiple doses of firategrast administered as the existing immediate release tablet formulation, as a modified release tablet (3hr) formulation and as simulated gastro-retentive formulation to be administered via naso-gastric tube for a period of 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male aged 18 to 65 yrs inclusive
- •Healthy, as determined by study physician
- •Capable of giving iformed consent
排除标准
- •Positive drugs of abuse result
- •Positive for HIV or Hepatitis B and/or C viruses
- •History of alcohol consumption in excess of average recommended weekly intake (more than 12 units for males)
- •Participation in a clinical trial within 30 days of scheduled first dose
研究组 & 干预措施
Treatment Arm ACB: Part 1
Subjects will receive treatment sequence ACB; A : Firategrast immediate release tablet 1200 milligram (mg) once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, B : Firategrast 3 hour release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses.
干预措施: Firategrast immediate release tablet (Drug)
Treatment Arm ACB: Part 1
Subjects will receive treatment sequence ACB; A : Firategrast immediate release tablet 1200 milligram (mg) once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, B : Firategrast 3 hour release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses.
干预措施: Firategrast modified release tablet (Drug)
Treatment Arm ACB: Part 1
Subjects will receive treatment sequence ACB; A : Firategrast immediate release tablet 1200 milligram (mg) once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, B : Firategrast 3 hour release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses.
干预措施: Firategrast gastro-retentive solution (Drug)
Treatment Arm BAC: Part 1
Subjects will receive treatment sequence BAC; B : Firategrast 3 hour release tablet 1200 mg once only orally, A : Firategrast immediate release tablet 1200 mg once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route. There will be a washout period of 5 days between doses.
干预措施: Firategrast immediate release tablet (Drug)
Treatment Arm BAC: Part 1
Subjects will receive treatment sequence BAC; B : Firategrast 3 hour release tablet 1200 mg once only orally, A : Firategrast immediate release tablet 1200 mg once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route. There will be a washout period of 5 days between doses.
干预措施: Firategrast modified release tablet (Drug)
Treatment Arm BAC: Part 1
Subjects will receive treatment sequence BAC; B : Firategrast 3 hour release tablet 1200 mg once only orally, A : Firategrast immediate release tablet 1200 mg once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route. There will be a washout period of 5 days between doses.
干预措施: Firategrast gastro-retentive solution (Drug)
Treatment Arm CBA: Part 1
Subjects will receive treatment sequence CBA; C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, B : Firategrast 3 hour release tablet 1200 mg once only orally, A : Firategrast immediate release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses.
干预措施: Firategrast immediate release tablet (Drug)
Treatment Arm CBA: Part 1
Subjects will receive treatment sequence CBA; C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, B : Firategrast 3 hour release tablet 1200 mg once only orally, A : Firategrast immediate release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses.
干预措施: Firategrast modified release tablet (Drug)
Treatment Arm CBA: Part 1
Subjects will receive treatment sequence CBA; C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, B : Firategrast 3 hour release tablet 1200 mg once only orally, A : Firategrast immediate release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses.
干预措施: Firategrast gastro-retentive solution (Drug)
Treatment Arm BCA: Part 1
Subjects will receive treatment sequence BCA; B : Firategrast 3 hour release tablet 1200 mg once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, A : Firategrast immediate release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses.
干预措施: Firategrast immediate release tablet (Drug)
Treatment Arm BCA: Part 1
Subjects will receive treatment sequence BCA; B : Firategrast 3 hour release tablet 1200 mg once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, A : Firategrast immediate release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses.
干预措施: Firategrast modified release tablet (Drug)
Treatment Arm BCA: Part 1
Subjects will receive treatment sequence BCA; B : Firategrast 3 hour release tablet 1200 mg once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, A : Firategrast immediate release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses.
干预措施: Firategrast gastro-retentive solution (Drug)
Treatment Arm CAB: Part 1
Subjects will receive treatment sequence CAB; C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, A : Firategrast immediate release tablet 1200 mg once only orally, B : Firategrast 3 hour release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses.
干预措施: Firategrast immediate release tablet (Drug)
Treatment Arm CAB: Part 1
Subjects will receive treatment sequence CAB; C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, A : Firategrast immediate release tablet 1200 mg once only orally, B : Firategrast 3 hour release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses.
干预措施: Firategrast modified release tablet (Drug)
Treatment Arm CAB: Part 1
Subjects will receive treatment sequence CAB; C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, A : Firategrast immediate release tablet 1200 mg once only orally, B : Firategrast 3 hour release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses.
干预措施: Firategrast gastro-retentive solution (Drug)
Treatment Arm ABC: Part 1
Subjects will receive treatment sequence ABC; A : Firategrast immediate release tablet 1200 mg once only orally, B : Firategrast 3 hour release tablet 1200 mg once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route. There will be a washout period of 5 days between doses.
干预措施: Firategrast immediate release tablet (Drug)
Treatment Arm ABC: Part 1
Subjects will receive treatment sequence ABC; A : Firategrast immediate release tablet 1200 mg once only orally, B : Firategrast 3 hour release tablet 1200 mg once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route. There will be a washout period of 5 days between doses.
干预措施: Firategrast modified release tablet (Drug)
Treatment Arm ABC: Part 1
Subjects will receive treatment sequence ABC; A : Firategrast immediate release tablet 1200 mg once only orally, B : Firategrast 3 hour release tablet 1200 mg once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route. There will be a washout period of 5 days between doses.
干预措施: Firategrast gastro-retentive solution (Drug)
Treatment Arm D: Part 2
Subject will receive D: Firategrast immediate release tablet 600 mg twice daily for 7 days
干预措施: Firategrast immediate release tablet (Drug)
Treatment Arm D: Part 2
Subject will receive D: Firategrast immediate release tablet 600 mg twice daily for 7 days
干预措施: Firategrast modified release tablet (Drug)
Treatment Arm D: Part 2
Subject will receive D: Firategrast immediate release tablet 600 mg twice daily for 7 days
干预措施: Firategrast gastro-retentive solution (Drug)
Treatment Arm E: Part 2
Subject will receive E: Firategrast 3 hour release tablet 1200 mg twice daily for 7 days
干预措施: Firategrast immediate release tablet (Drug)
Treatment Arm E: Part 2
Subject will receive E: Firategrast 3 hour release tablet 1200 mg twice daily for 7 days
干预措施: Firategrast modified release tablet (Drug)
Treatment Arm E: Part 2
Subject will receive E: Firategrast 3 hour release tablet 1200 mg twice daily for 7 days
干预措施: Firategrast gastro-retentive solution (Drug)
Treatment Arm F: Part 2
Subject will receive F: Firategrast simulated gastro-retentive solution 1200 mg twice daily for 7 days
干预措施: Firategrast immediate release tablet (Drug)
Treatment Arm F: Part 2
Subject will receive F: Firategrast simulated gastro-retentive solution 1200 mg twice daily for 7 days
干预措施: Firategrast modified release tablet (Drug)
Treatment Arm F: Part 2
Subject will receive F: Firategrast simulated gastro-retentive solution 1200 mg twice daily for 7 days
干预措施: Firategrast gastro-retentive solution (Drug)
结局指标
主要结局
PK measures for single and repeat dose
时间窗: Part 1 approx 4 weeks, Part 2 approx 8 days
AUC(0-t) of firategrast
Pharmacokinetic measures for single and repeat dose
时间窗: Part 1: approx. 4 weeks, Part 2: approx 8 days
Cmax of firategrast
Pharmacokinetic measurements for single and repeat dose
时间窗: Part 1: approx 4 weeks, Part 2: approx 8 days
AUC(0-24) of firategrast
次要结局
- Safety & Tolerability in single and repeat doses(Part 1: approx. 4 weeks, Part 2: approx 8 days)
- CD34 positive cell count(Part 1 only approx 4 weeks)