Study Assessing PTI-428 Safety, Tolerability, and Pharmacokinetics in Subjects With Cystic Fibrosis
Public ClinicalTrials.gov record NCT02718495. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This trial will consist of three arms: Part A, Part B, and Part C. Part A has two groups. The first group will enroll adult subjects with cystic fibrosis (CF) into a single ascending dose (SAD) treatment group. The second group will enroll adult subjects with CF, including those on background treatment with ORKAMBI® and those not on a cystic fibrosis transmembrane conductance regulator (CFTR) modulator, into a multiple ascending dose (MAD) treatment group. Part B will enroll adult subjects with CF currently on stable ORKAMBI® background therapy for a minimum of 3 months into a Phase II treatment group consisting of two cohorts. Part C will enroll adult subjects with CF, including those on background treatment with KALYDECO® and those not on a CFTR modulator, into a Phase II treatment group consisting of three cohorts. Approximately 136 subjects will be enrolled.
Study identification
- NCT ID
- NCT02718495
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 56 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 19, 2016 (Actual)
- Primary completion
- Nov 28, 2017 (Actual)
- Completion
- Nov 28, 2017 (Actual)
- Last update posted
- Mar 21, 2019
2016 – 2017
United States locations
- U.S. sites
- 20
- U.S. states
- 16
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford University Medical Center | Stanford | California | 94305 | — |
| Central Florida Pulmonary Group | Altamonte Springs | Florida | 32803 | — |
| University of Florida College of Medicine | Gainesville | Florida | 32610 | — |
| St. Luke's Cystic Fibrosis Center of Idaho | Boise | Idaho | 83712 | — |
| Northwestern University Memorial Hospital | Chicago | Illinois | 60611 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| University of Kansas Medical Center Research Institute, Inc. | Kansas City | Kansas | 66160 | — |
| Quintiles Overland Park Phase 1 Unit | Overland Park | Kansas | 66211 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Childrens Hospital Boston | Boston | Massachusetts | 02115 | — |
| Universiy of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Children's Lung Specialists | Las Vegas | Nevada | 89107 | — |
| Duke University Health System | Durham | North Carolina | 27710 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | 19107 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02718495, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 21, 2019 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02718495 live on ClinicalTrials.gov.