An Open-Label, Phase I Study to Assess the Pharmacokinetic Interaction Between Repeat Doses of Oral Casopitant and Intravenous and Oral Doses of Dexamethasone and Intravenous and Oral Doses of Ondansetron When Administered in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Part A: Period 1 & 2: Plasma levels of casopitant, dexamethasone, & ondansetron will be checked on Day 1, 2 and/or 3. Part B: Period 1, 2 & 3: Plasma levels of casopitant, dexamethasone, & ondansetron will be checked on Day 1, 2 and/or 3.
研究概览
简要总结
GW679769 may affect liver enzymes that metabolize dexamethasone and ondansetron. This study is designed to test the safety and the extent of the GW679769 affect on dexamethasone and ondansetron levels in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Healthy adult males or females
- •Age: 18 to 55 years, inclusive
- •A female subject who is non-childbearing potential or using acceptable contraceptive methods.
- •Adequate organ systems function
- •Able to swallow and retain oral medication
- •Able to understand and comply with protocol requirements and instruction and is likely to complete the study.
排除标准
- •Cannot participation if subject has a clinically relevant abnormality, medical condition, or circumstance that makes them unsuitable for the study per the study doctor.
- •History of drug or other allergy which, in the opinion of the Investigator, contraindicates participation.
- •Use of an investigation drug within 28 days or 5 half-lives.
- •Blood donation in excess of 500mL within 56 days prior to dosing or intends to donate within 30 days of the post-treatment follow-up visit.
- •Presence of or suspected iron deficiency
- •Positive stool for occult blood
- •Female subject who is lactating
- •Positive urine drug screen
- •Positive for HIV antibody, hepatitis C antibody or hepatitis B surface antigen
- •Use of tobacco-containing products within the past 12 months prior to screening
- •History of drug or alcohol abuse or dependence within 6 months of screening
- •History or presence of uncontrolled emesis
- •Positive purified protein derivative (PPD) skin test for tuberculosis
研究组 & 干预措施
Subjects in Part B
In PART B, subjects received Regimen D: oral casopitant alone (150 mg QD Day 1, 50 mg QD Days 2 and 3); Regimen E: IV dexamethasone (8 mg single-dose Day 1 only) and oral ondansetron (8 mg BID Days 1 to 3); and Regimen F: oral casopitant regimen as in Regimen D, and IV dexamethasone and oral ondansetron as in Regimen E.
干预措施: Casopitant (GW679769) Oral Tablets (Drug)
Subjects in Part A
In PART A, subjects received Regimen A: oral casopitant alone (150 mg once daily [QD] Day 1, 50 mg QD Days 2 and 3); Regimen B: oral dexamethasone (20 mg QD Day 1 and 8 mg twice daily [BID] Days 2 and 3) and intravenous (IV) ondansetron (32 mg single-dose Day 1); and Regimen C: oral casopitant as in Regimen A, IV ondansetron as in Regimen B and a lower dose oral dexamethasone than in Regimen B (12 mg QD Day 1, 8 mg QD Days 2 and 3).
干预措施: Casopitant (GW679769) Oral Tablets (Drug)
Subjects in Part A
In PART A, subjects received Regimen A: oral casopitant alone (150 mg once daily [QD] Day 1, 50 mg QD Days 2 and 3); Regimen B: oral dexamethasone (20 mg QD Day 1 and 8 mg twice daily [BID] Days 2 and 3) and intravenous (IV) ondansetron (32 mg single-dose Day 1); and Regimen C: oral casopitant as in Regimen A, IV ondansetron as in Regimen B and a lower dose oral dexamethasone than in Regimen B (12 mg QD Day 1, 8 mg QD Days 2 and 3).
干预措施: ondansetron (Drug)
Subjects in Part A
In PART A, subjects received Regimen A: oral casopitant alone (150 mg once daily [QD] Day 1, 50 mg QD Days 2 and 3); Regimen B: oral dexamethasone (20 mg QD Day 1 and 8 mg twice daily [BID] Days 2 and 3) and intravenous (IV) ondansetron (32 mg single-dose Day 1); and Regimen C: oral casopitant as in Regimen A, IV ondansetron as in Regimen B and a lower dose oral dexamethasone than in Regimen B (12 mg QD Day 1, 8 mg QD Days 2 and 3).
干预措施: dexamethasone (Drug)
Subjects in Part B
In PART B, subjects received Regimen D: oral casopitant alone (150 mg QD Day 1, 50 mg QD Days 2 and 3); Regimen E: IV dexamethasone (8 mg single-dose Day 1 only) and oral ondansetron (8 mg BID Days 1 to 3); and Regimen F: oral casopitant regimen as in Regimen D, and IV dexamethasone and oral ondansetron as in Regimen E.
干预措施: dexamethasone (Drug)
Subjects in Part B
In PART B, subjects received Regimen D: oral casopitant alone (150 mg QD Day 1, 50 mg QD Days 2 and 3); Regimen E: IV dexamethasone (8 mg single-dose Day 1 only) and oral ondansetron (8 mg BID Days 1 to 3); and Regimen F: oral casopitant regimen as in Regimen D, and IV dexamethasone and oral ondansetron as in Regimen E.
干预措施: ondansetron (Drug)
结局指标
主要结局
Part A: Period 1 & 2: Plasma levels of casopitant, dexamethasone, & ondansetron will be checked on Day 1, 2 and/or 3. Part B: Period 1, 2 & 3: Plasma levels of casopitant, dexamethasone, & ondansetron will be checked on Day 1, 2 and/or 3.
时间窗: checked on Day 1, 2 and/or 3
次要结局
- Vitals Signs taken & Adverse Events monitored(at each visit starting at Day -1.)
- 12 lead ECGs & Serum Pepsinogen level tests(at Screening & Followup.)
- Safety is evaluated by: Clinical Lab Tests done(at Screening, Day -1 & Followup.)