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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 is a Phase 2 study that has completed, run by Proteostasis Therapeutics. The registered enrollment target is 40 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03591094
The ClinicalTrials.gov registry entry for NCT03591094 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Proteostasis Therapeutics, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03591094 reports 0 study locations.
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.
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