NCT01225640已完成2 期
A Phase 2a, Open-Label, Randomized Study In Treatment-Naive, Sputum Smear Positive Subjects With Drug-Sensitive Pulmonary Tuberculosis To Assess Early Bactericidal Activity (EBA) And Whole Blood Activity (WBA) Of PNU-100480 (PF-02341272)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- The primary endpoint is rate of change in sputum log CFU/mL count (EBA) from Days 0-2.
研究概览
简要总结
PNU-100480 is being developed for the treatment of both drug resistant and sensitive tuberculosis. This is an efficacy and safety study to characterize the effect of PNU-100480 when given for 14 days to treatment-naive patients with drug-sensitive pulmonary tuberculosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males or females between 18 and 65 years; women of childbearing potential must be willing to adhere to lifestyle requirements regarding contraception/pregnancy prevention.
- •Newly diagnosed sputum smear-positive pulmonary TB confirmed with acid-fast bacillus (AFB) smear and chest x-ray. Patients with TB more than 5 years ago who completed treatment, are healthy, and meet other inclusion criteria may be included.
- •Body weight between 40 and 90 kg, inclusive (in light clothing, no shoes).
- •Reasonably normal hemoglobin (>=8 gm/dL), renal function (serum creatinine <2 mg/dL), hepatic function (serum AST <3xULN and total bilirubin <1.3 mg/dL), and random glucose <150 mg/dL.
排除标准
- •HIV infection with helper/inducer T-lymphocytes (CD4 cell) count of <=350x10-6/L.
- •Presence of significant hemoptysis. Subjects who cough up frank blood (more than blood streaked sputum) will not be eligible.
- •Pregnant or nursing females; females of childbearing potential unwilling or unable to adhere to contraception guidelines.
- •Significant respiratory impairment (respiratory rate >35/minute).
- •Clinical suspicion of disseminated TB or tuberculosis meningitis.
- •Subjects with diabetes mellitus on insulin and/or who have poorly controlled disease.
- •Subjects with confirmed or suspected multi-drug resistant TB.
研究组 & 干预措施
PNU-100480 600 mg BID
Experimental
干预措施: PNU-100480 (Drug)
PNU-100480 1200 mg QD
Experimental
干预措施: PNU-100480 (Drug)
RHZE
Active Comparator
conjugated tablet with 4 drug combination of RHZE, Rifafour® e275 will be used in countries where can be sourced locally
干预措施: RHZE (Drug)
结局指标
主要结局
The primary endpoint is rate of change in sputum log CFU/mL count (EBA) from Days 0-2.
时间窗: Days 0-2
次要结局
- Rate of change in culture time to positivity (TTP) measured by MGIT and in log transformed TTP(Days 02-; 2-14; 0-14)
- Cumulative whole blood bactericidal activity (measured as log reduction in CFU) against intracellular M. tuberculosis relative to administered dose and drug PK(Day 13-14)
- Plasma concentrations of PNU-100480 and PNU-101603 will be used to determine PK parameters (AUCtau, AUC tau,ss, Cmax, Tmax, terminal half-life t1/2, Cavg, Rac) as data permit(Day 13-14)
- Safety assessments including physical exams, AEs, laboratory tests, ECGs, and vital signs.(Lab tests at Screening, Day 1, Day 15 and 42/Follow-up)
- Rate of change in sputum log CFU/mL count (extended EBA).(Days 0-14)
研究者
研究点 (1)
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