NL-OMON42687已完成不适用
Evaluation of Pharmacokinetics, Relative Bioavailability, and Tolerability of Three Different Formulations of PA101 in Healthy Subjects, Patients with Systemic Mastocytosis, and Patients with Chronic Cough due to Idiopathic Pulmonary Fibrosis - PATARA PA101-PK-02
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Part 1: Healthy Subjects
- •1. Male or female subjects 18-45 years of age, inclusive
- •2. Body weight > 50 kg and Body Mass Index of 18-25 kg/m2, inclusive
- •3. Normal 12-lead ECG recording at the Screening Visit
- •4. Normal or clinically insignificant changes in 12-lead ECG recording at the Screening Visit
- •1. Male or female subjects 18-65 years of age, inclusive
- •2. Diagnosed with indolent systemic mastocytosis (ISM) according to the WHO criteria
- •3. History of gastrointestinal symptoms related to systemic mastocytosis
- •4. Clinically stable systemic mastocytosis
- •5. Normal lung function (FEV1 >= 90% of predicted normal value) at the Screening Visit;Part 3:
- •1. Male or female patients age 40 through 75 years, inclusive
- •2. Diagnosis of Idiopathic Pulmonary Fibrosis with the consensus of the multidisciplinary team based on the presence of definitive or possible usual interstitial pneumonia (UIP) pattern on high-resolution computed tomography (HRCT) and after excluding alternative diagnoses, including lung diseases associated with environmental and occupational exposure, with connective tissue diseases and with drugs
- •3. Chronic cough present for at least 8 weeks and not responsive to current therapies
- •4. Daytime cough severity score on visual analogue scale > 40 mm at the Screening Visit
- •5. Transfer capacity for carbon monoxide corrected for hemoglobin (TLCOc) > 25% predicted value and Forced Vital Capacity (FVC) > 50% predicted value within 3 months of the Screening Visit
排除标准
- •1. Current or recent history of clinically significant cardiovascular, respiratory, hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant or other illnesses that could put the subject at risk or compromise the quality of the study data as determined by the investigator
- •2. An upper or lower respiratory tract infection within 4 weeks
- •1. Aggressive systemic mastocytosis, mast cell leukemia, or systemic mastocytosis with an associated clonal hematologic non-mast cell disorder
- •2. Current or recent history of clinically significant cardiovascular, respiratory, hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant or other illnesses that could put the subject at risk or compromise the quality of the study data as determined by the investigator
- •3. History of systemic corticosteroid use within 6 weeks or immunosuppressive therapy within 6 months of the Screening Visit
- •1. Current or recent history of clinically significant medical condition, laboratory abnormality, or illness that could put the patient at risk or compromise the quality of the study data as determined by the investigator
- •2. Significant cardiac disease (i.e., myocardial infarction within 6 months or unstable angina within 1 month of the Screening Visit)
- •3. An upper or lower respiratory tract infection within 4 weeks of the Screening Visit
- •4. Acute exacerbation of IPF within 3 months of the Screening Visit
- •5. Long-term daily oxygen therapy (>10 hours/day)
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