Study Assessing the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic Fibrosis

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteer, Cystic Fibrosis

In brief

This trial will consist of two parts: Part 1 and Part 2. Part 1 will enroll adult healthy volunteers (HV) into four treatment groups. The first group will enroll HV into a single ascending dose (SAD) treatment group consisting of three cohorts. The second group will enroll HV into a multiple ascending dose (MAD) treatment group consisting of three cohorts. The third group will enroll HV into a food effect (FE) treatment group consisting of one cohort. The fourth group will enroll HV into a drug-drug interactions (DDI) treatment group consisting of one cohort. Approximately 76 subjects will be enrolled in Part 1. Part 2 Cohorts 1 through 3 will enroll adult subjects with cystic fibrosis (CF) currently on stable ivacaftor/lumacaftor background therapy for a minimum of three months. Part 2 Cohorts 4 and Cohort 5 will enroll adult subjects with CF not currently receiving cystic fibrosis conductance regulator (CFTR) modulator therapy within 30 days prior to Day 1. Part 2 Cohort 6 will enroll adult subjects with cystic fibrosis on stable tezacaftor/ivacaftor background therapy. Approximately 104 subjects will be enrolled in Part 2.

Key facts

Study ID

NCT03140527

Run by

Proteostasis Therapeutics, Inc.

People needed

171

Starts

2017-04-10

Expected to finish

2020-02-27

Last updated by the study team

2020-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States
• Stanford University Medical Center — Stanford, California, United States
• National Jewish Health — Denver, Colorado, United States
• Central Florida Pulmonary Group — Altamonte Springs, Florida, United States
• University of Florida College of Medicine — Gainesville, Florida, United States
• University of Miami Health System — Miami, Florida, United States
• St. Luke's CF Center of Idaho — Boise, Idaho, United States
• Northwestern University Memorial Hospital — Chicago, Illinois, United States
• OSF Saint Francis Medical Center — Peoria, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• Maine Medical Center — Portland, Maine, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Children's Mercy Kansas City — Kansas City, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Children's Lung Specialists — Las Vegas, Nevada, United States
• Columbia University Medical Center — New York, New York, United States
• Mount Sinai Beth Israel — New York, New York, United States
• New York Medical College — Valhalla, New York, United States
• Duke University Health System — Durham, North Carolina, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Toledo Children's Hospital — Toledo, Ohio, United States

Full record on ClinicalTrials.gov

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