EUCTR2016-001214-24-DK
Active, not recruiting
Phase 1
A Phase I/II Multi-center, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmacokinetics of PTI-428 in Subjects with Cystic Fibrosis - Proteostasis PTI428
Proteostasis Therapeutics0 sites144 target enrollmentApril 28, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Proteostasis Therapeutics
- Enrollment
- 144
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •General study inclusion criteria:
- •1\. Adult males or females age 18 years and older
- •2\. Confirmed diagnosis of CF, defined as:
- •\- A sweat chloride value \=60 mmol/L by quantitative pilocarpine iontophoresis and Clinical findings consistent with CF such as chronic sinopulmonary disease or gastrointestinal/nutritional abnormalities.
- •\- 2 CF\-causing mutations (all as documented in the subject’s medical record) and Clinical findings consistent with CF such as chronic sinopulmonary disease or gastrointestinal/nutritional abnormalities.
- •3\. FEV1 between 40\-90% predicted
- •4\. Pulse Oximetry \> 92% at rest
- •5\. Body mass index (BMI) \=17 kg/m2
- •6\. Subjects of child\-bearing potential and who are sexually active must meet the study contraception requirements.
- •7\. Non\-smoker and non\-tobacco user for a minimum of 30 days prior to screening and for the duration of the study.
Exclusion Criteria
- •1\. History or current evidence of any clinically significant cardiac, endocrinologic,
- •hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary (besides
- •CF), neurologic, dermatologic, psychiatric, renal, or other major disease, as determined
- •by the Investigator.
- •2\. History of prolonged QT/QTc interval with Fridericia’s correction QTcF \> 450 msec
- •at screening.
- •3\. Abnormal liver function as defined by:
- •a. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) or bilirubin
- •\> 3 x upper limit of the normal range.
- •4\. Abnormal renal function at screening defined as:
Outcomes
Primary Outcomes
Not specified
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