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NCT03140527 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Cystic Fibrosis and Healthy Volunteer, sponsored by Proteostasis Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 171
- Enrollment target
- 20
- Study locations
NCT03140527: Completed Phase 1 study of Cystic Fibrosis and Healthy Volunteer, sponsored by Proteostasis Therapeutics.
NCT03140527 is a Phase 1 study of Cystic Fibrosis and Healthy Volunteer that has completed, run by Proteostasis Therapeutics. The registered enrollment target is 171 participants, roughly in line with the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target. The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03140527, a Phase 1 study of Cystic Fibrosis and Healthy Volunteer, has completed, sponsored by Proteostasis Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 171 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG PTI-808
- DRUG PTI-801
Study Locations (20)
Florida
- Central Florida Pulmonary Group - Altamonte Springs
- University of Florida College of Medicine - Gainesville
- University of Miami Health System - Miami
Illinois
- Northwestern University Memorial Hospital - Chicago
- OSF Saint Francis Medical Center - Peoria
Massachusetts
- Massachusetts General Hospital - Boston
- Boston Children's Hospital - Boston
New York
- Columbia University Medical Center - New York
- Mount Sinai Beth Israel - New York
Alabama
- University of Alabama at Birmingham - Birmingham
Alaska
- Providence Alaska Medical Center - Anchorage
California
- Stanford University Medical Center - Stanford
Colorado
- National Jewish Health - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2017-04-10 |
| Est. Completion | 2020-02-27 |
| Phase | Phase 1 |
What the finished NCT03140527 record still lists
NCT03140527 is an interventional study that assigns participants to a tested intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target.
The record links to 2 conditions, with Cystic Fibrosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03140527 names 20 study sites across 15 states, led by Florida, Illinois, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03140527 about?
NCT03140527 is a clinical study titled "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". 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 ascendi...
What is the current status of trial NCT03140527?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 171 participants. The study started on 2017-04-10. Estimated completion is 2020-02-27.
What conditions does trial NCT03140527 study?
This clinical trial studies the following conditions: Cystic Fibrosis, Healthy Volunteer.
What interventions are being tested in trial NCT03140527?
The interventions under investigation include: Placebo (DRUG), PTI-808 (DRUG), PTI-801 (DRUG).
Who is sponsoring clinical trial NCT03140527?
This trial is sponsored by Proteostasis Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03140527 being conducted?
This trial has 20 study locations across Alabama, Alaska, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03140527's enrollment target sits among peer trials
171 39th of 169 higher than 131 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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