NCT02251769已完成1 期
A Single-centre Open-label Study in Healthy Adult Volunteers to Determine the Effects of Single-dose and Steady-state TPV/r (500 mg/200 mg) on the Steady-state Pharmacokinetics of Clarithromycin (BIAXIN®) 500 mg Bid and a Preliminary Assessment of the Effects of a Standard High-fat Test Meal on the Steady-state Pharmacokinetics of Tipranavir
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Area under plasma concentration time curve from 0-12 hours (AUC0-12h)
研究概览
简要总结
To determine the effects of single-dose and steady-state Tipranavir/Ritonavir (TPV/r) at 500 mg/200 mg bid on the steady-state pharmacokinetics of clarithromycin and to determine the effects of a standard high-fat test meal on the steady-state pharmacokinetics of tipranavir.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects between 18 and 60 years of age inclusive
- •A Body Mass Index (BMI) between 18 and 29 kg/m2
- •Signed informed consent prior to trial participation
- •Ability to swallow multiple capsules without difficulty
- •Ability to ingest a standard high-fat test meal
- •Acceptable laboratory values that indicated adequate baseline organ function were required at the time of screening. Laboratory values were considered to be acceptable if severity was less than or equal to Grade 1, based on the AIDS Clinical Trials Group (ACTG) Grading Scale
- •Acceptable medical history, physical examination and 12-lead ECG were required prior to entering the treatment phase of the study
- •Willingness to abstain from alcohol for 48 hours prior to study Day 0 and abstain from alcohol for the duration of the study. In addition, ingestion of red wine is not allowed within 5 days prior to Day 0 (Visit 2)
- •Willingness to abstain from grapefruit or grapefruit juice or products containing grapefruit juice starting 10 days prior to any administration of study drug up until the end of the study
- •Willingness to abstain from ingestion of Seville oranges, garlic supplements, St. John's Wort, or Milk Thistle, within 5 days of treatment and for the duration of the study
- •Willingness to abstain from methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.) within 48 hours of each pharmacokinetic sampling day and until after the last sample from each of the intensive sampling days was collected
- •Willingness to abstain from over the counter herbal medications for the duration of the study
- •Willingness to abstain from vigorous physical exercise during intensive pharmacokinetic days
- •Reasonable probability for completion of the study
- •Non-smokers for at least 3 months prior to Day 0
排除标准
- •Female subjects who are of reproductive potential and who:
- •Have positive serum β-hCG at Visit 1, or on Day 0
- •Are not using a barrier contraceptive method for at least 3 months prior to Visit 2 (Day 0)
- •Are not willing to use a reliable method of barrier contraception (such as diaphragm or condoms), during the trial and for 30 days after trial completion/termination
- •Are breast-feeding
- •Use of any pharmacological contraceptive (including oral, patch or injectable contraceptives) within 1 month prior to study initiation and for the duration of the study
- •Use of hormone replacement therapy within 1 month prior to study initiation and for the duration of the study
- •Participation in another trial with an investigational medicine within 60 days prior to Day 0 (Visit 2)
- •Use of any prohibited medication listed in the protocol within 30 days prior to Day 0 (Visit 2)
- •Administration of antibiotics within 10 days prior to Day 0 (Visit 2) or during the trial
- •History of acute illness within 60 days of trial initiation. Subjects are excluded for these disorders greater than 60 days if, in the opinion of the investigator, the subject does not qualify as a healthy volunteer
- •Serological evidence of hepatitis B (HBV) or hepatitis C (HCV)
- •Serological evidence of exposure to HIV
- •Recent history of alcohol or substance abuse (within 6 months of study period)
- •Blood or plasma donations within 30 days prior to Day 0 (Visit 2) or during the trial
- •Subjects with a seated systolic blood pressure either <100 mm Hg or >150 mm Hg
- •Subjects with a history of any illness or allergy that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering tipranavir (TPV), ritonavir (RTV) or clarithromycin (CLR) to the subject
- •Subjects who have taken, within 7 days prior to Day 0 (Visit 2), any over-the-counter or prescription drugs that, in the opinion of the investigator in consultation with the BI clinical monitor, might interfere with either the absorption, distribution or metabolism of the test substances
- •Known hypersensitivity to TPV, RTV, sulfonamides, or CLR
- •Lactose intolerance or intolerance to high-fat foods
- •Allergies or intolerance to foods such as soybean, wheat, milk, eggs or gluten
- •Inability to adhere to requirements of the protocol
研究组 & 干预措施
Sequential administration
Experimental
干预措施: Tipranavir (Drug)
Sequential administration
Experimental
干预措施: Ritonavir (Drug)
Sequential administration
Experimental
干预措施: Clarithromycin (Drug)
Sequential administration
Experimental
干预措施: High-Fat Test Meal (Other)
结局指标
主要结局
Area under plasma concentration time curve from 0-12 hours (AUC0-12h)
时间窗: up to 12 hours
Maximum plasma concentration (Cmax)
时间窗: up to 12 hours
Plasma trough concentration (Cp12h)
时间窗: up to 12 hours
次要结局
- Oral clearance (CL/F)(up to 12 hours)
- Volume of distribution (V)(up to 12 hours)
- Apparent terminal half life (t1/2)(up to 12 hours)
- Time of maximum concentration (Tmax)(up to 12 hours)
- Mean Residency Time (MRT)(up to 12 hours)
- Number of patients with adverse events(up to day 13)
- Number of patients with clinically significant laboratory findings(up to day 13)
研究者
相似试验
已完成
1 期
Effects of Steady-state TPV/RTV on the Single-dose Pharmacokinetics of Rifabutin and the Effects of Single-dose Rifabutin on the Steady-state Pharmacokinetics of TPV in Healthy Adult VolunteersHealthyNCT02251171Boehringer Ingelheim24
已完成
1 期
Effects of Tipranavir (With Ritonavir) Capsule and Liquid Formulation on Cytochrome P450 and P-glycoprotein Activity in Healthy VolunteersHealthyNCT02243553Boehringer Ingelheim34
已完成
1 期
Effects of Tipranavir (TPV) and Ritonavir (RTV) on the Pharmacokinetic Characteristics of Tenofovir Disoproxil Fumarate in Healthy VolunteersHealthyNCT02251145Boehringer Ingelheim49
终止
1 期
Effect of Tipranavir and Ritonavir on the Pharmacokinetic Characteristics of Norethindrone-Ethinyl Estradiol in Healthy Female Adult VolunteersHealthyNCT02245438Boehringer Ingelheim52
已完成
1 期
Pharmacokinetic of Tadalafil Co-administered With Tipranavir/Ritonavir to Healthy Male VolunteersHealthyNCT02253862Boehringer Ingelheim17