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NCT03591094 · ClinicalTrials.gov registry record · Phase 2
Study Assessing PTI-428 Safety, Tolerability, Pharmacokinetics and Effect in Subjects With Cystic Fibrosis
A Phase 2 study, sponsored by Proteostasis Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT03591094: Completed Phase 2 study, sponsored by Proteostasis Therapeutics.
NCT03591094 is a Phase 2 study that has completed, run by Proteostasis Therapeutics. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03591094, a Phase 2 study, has completed, sponsored by Proteostasis Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
The study population is comprised of adult subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation and are currently receiving background treatment with tezacaftor/ivacaftor for a minimum of 1 month prior to Day 1. The planned sample size is approximately 40 subjects. 20 subjects will be assigned to PTI-428 dose level 1 or placebo and 20 subjects will be assigned to PTI-428 dose level 2 or placebo. At each dose level, subjects will be randomized at a 3:1 randomization ratio. Subjects will receive once daily oral doses of PTI-428 or placebo for 28 days, while the subjects continue to receive background treatment with tezacaftor/ivacaftor per product label. The study drug administration period will be followed by a 14-day safety follow-up period.
Primary Outcome
Safety and tolerability will be assessed by adverse events (AEs), safety labs, electrocardiograms (ECGs), physical examinations and vital signs.
Interventions
- DRUG Placebo
- DRUG PTI-428
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-08-21 |
| Est. Completion | 2019-02-18 |
| Phase | Phase 2 |
What the finished NCT03591094 record still lists
NCT03591094 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03591094 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03591094 about?
NCT03591094 is a clinical study titled "Study Assessing PTI-428 Safety, Tolerability, Pharmacokinetics and Effect in Subjects With Cystic Fibrosis". The study population is comprised of adult subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation and are currently receiving background treatment with tezacaftor/ivacaftor for a minimum of 1 month prior to Day 1. The planned sample size is approximately 40 subjects. 20 subje...
What is the current status of trial NCT03591094?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2018-08-21. Estimated completion is 2019-02-18.
What interventions are being tested in trial NCT03591094?
The interventions under investigation include: Placebo (DRUG), PTI-428 (DRUG).
Who is sponsoring clinical trial NCT03591094?
This trial is sponsored by Proteostasis Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03591094's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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