NCT00481182已完成1 期
A Phase I, Open-Label, 2-Period, Single-Sequence, Drug Interaction Study to Assess Steady-State Plasma Methadone Enantiomer Pharmacokinetics Following Co-Administration of Methadone QD With Fosamprenavir 700mg BID + RTV 100mg BID in Opiate-Dependent, HIV Seronegative, Adult Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Serial blood samples will be collected over 24 hours for measurement of plasma (R-) and (S-) methadone (days 4 and 18) and serum amprenavir concentrations (day 18).
研究概览
简要总结
To assess the combined effects of fosamprenavir 700mg BID + ritonavir 100mg BID + standardized dose of methadone, on plasma total and unbound methadone enantiomer pharmacokinetics (PK), opiate pharmacodynamic (PD) measures, and safety. The effect of methadone on plasma amprenavir PK will also be assessed by comparison to historical control data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is enrolled in a certified methadone maintenance program for at least 12 weeks prior to Period 1, Day
- •Subject is receiving methadone = 200mg QD that has remained unchanged for 30 days The subject is male, female and is between the age of 18 and 64 years of age.
- •A female is eligible to enter and participate if she is of non-childbearing potential or of childbearing potential. If of childbearing potential, females must have a negative serum pregnancy test at Screening, and agree to one of the following:
- •Complete abstinence from sexual intercourse from 2 weeks prior to administration of the study drug. Sexual intercourse with only vasectomized partner.
- •Body mass index of 19.00 to 32.00 kg/m
- •Willing to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.
- •Able to understand and comply with protocol requirements and instructions and is likely to complete the study as planned.
- •Able to give written informed consent prior to screening.
排除标准
- •Subject has a clinically significant abnormality identified on the screening medical or laboratory evaluation, including 12-lead ECG.
- •Subject has any preexisting condition which could interfere with the absorption, metabolism, and/or excretion of the study drugs.
- •Subject currently has or has a history of decompensated liver disease (i.e., ascites, esophageal or rectal varices, hepatic encephalopathy) or current evidence of active hepatitis (AST or ALT > 2.5x ULN).
- •Subject has evidence of liver impairment at screening (i.e., INR > 1.7, total bilirubin >2.0 mg/dL, albumin <3.5 g/dL).
- •Subject has inadequate venous access. Subject has a history of any hypersensitivity reaction to any component of FPV, APV, RTV, or to any drug chemically related to FPV, APV, or RTV.
结局指标
主要结局
Serial blood samples will be collected over 24 hours for measurement of plasma (R-) and (S-) methadone (days 4 and 18) and serum amprenavir concentrations (day 18).
次要结局
- On study days 4, 11, and 18, opioid effects will be assessed pre-dose, 2 hours, and 6 hours following methadone dosing. Pharmacokinetic and opioid pharmacodynamic parameters will be compared between the two treatments.
研究者
研究点 (3)
Loading locations...
相似试验
已完成
1 期
PF-07321332/Ritonavir and Ritonavir on Dabigatran Study in Healthy ParticipantsHealthy ParticipantsNCT05064800Pfizer24
已完成
3 期
KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 WeeksHIV InfectionInfection, Human Immunodeficiency VirusNCT00085943GlaxoSmithKline866
已完成
不适用
PENTA Fosamprenavir StudyInfection, Human Immunodeficiency VirusNCT01077635ViiV Healthcare1
已完成
1 期
Effects of Tipranavir (TPV) and Ritonavir (RTV) on the Pharmacokinetic Characteristics of Tenofovir Disoproxil Fumarate in Healthy VolunteersHealthyNCT02251145Boehringer Ingelheim49
已完成
1 期
Drug-Drug Interaction Study Assessing Effect of Carbamazepine on PF-07321332 Boosted With RitonavirHealthy ParticipantNCT04962230Pfizer12