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Clinical Trials/EUCTR2016-001214-24-DE
EUCTR2016-001214-24-DE
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 sites132 target enrollmentApril 10, 2017
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ConditionsCystic FibrosisMedDRA version: 20.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Cystic Fibrosis
Sponsor
Proteostasis Therapeutics
Enrollment
132
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 10, 2017
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Proteostasis Therapeutics

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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