Potential Pharmacokinetic Interaction of Human Immunodeficiency Virus (HIV) Antiretroviral Agents as Fixed-dose Combinations and Riociguat in HIV Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 40
- 主要终点
- AUC of riociguat main metabolite M1 (BAY 60-4552)
研究概览
简要总结
To investigate the pharmacokinetic drug-drug interaction potential of fixed dose antiretroviral therapies, i.e. ATRIPLA, COMPLERA, STRIBILD, TRIUMEQ, or any approved antiretroviral protease inhibitor in combination with (preferably) TRIUMEQ, on the exposure to riociguat in HIV patients on a stable dose of one of these therapies.
• To Assess the safety and tolerability of riociguat treatment in combination with these fixed-dose antiretroviral therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged >=18 to <65 years with a confirmed diagnosis of HIV receiving a stable regimen of ATRIPLA, COMPLERA, STRIBILD, TRIUMEQ, or any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir in combination with (preferably) TRIUMEQ consistent with the most recent prescribing information documents for at least 6 weeks before concomitant administration of a single oral dose of 0.5 mg riociguat
- •No clinical evidence of pulmonary hypertension
- •Written informed consent
排除标准
- •Severe diseases for which it can be assumed that the pharmacokinetics or effects of the study drug will not be normal
- •History of coronary artery disease
- •Symptomatic postural hypotension (e.g. dizziness, lightheadedness)
- •History of bronchial asthma or any other airway disease
- •Renal impairment with creatinine clearance <15 mL/min
- •Severe hepatic impairment (Child-Pugh class C)
- •Systolic blood pressure below 100 mmHg
研究组 & 干预措施
Riociguat and ATRIPLA
干预措施: Riociguat (Adempas, BAY 63-2521) (Drug)
Riociguat and ATRIPLA
干预措施: ATRIPLA (Drug)
Riociguat and COMPLERA
干预措施: Riociguat (Adempas, BAY 63-2521) (Drug)
Riociguat and COMPLERA
干预措施: COMPLERA (Drug)
Riociguat and STRIBILD
干预措施: Riociguat (Adempas, BAY 63-2521) (Drug)
Riociguat and STRIBILD
干预措施: STRIBILD (Drug)
Riociguat and TRIUMEQ
干预措施: Riociguat (Adempas, BAY 63-2521) (Drug)
Riociguat and TRIUMEQ
干预措施: TRIUMEQ (Drug)
Riociguat and antiretroviral protease inhibitor with TRIUMEQ
干预措施: Riociguat (Adempas, BAY 63-2521) (Drug)
Riociguat and antiretroviral protease inhibitor with TRIUMEQ
干预措施: Antiretroviral protease inhibitor (Drug)
结局指标
主要结局
AUC of riociguat main metabolite M1 (BAY 60-4552)
时间窗: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
Cmax of riociguat main metabolite M1 (BAY 60-4552)
时间窗: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
AUC of riociguat
时间窗: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
Cmax of riociguat
时间窗: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
次要结局
未报告次要终点