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
Public ClinicalTrials.gov record NCT03140527. 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 Multi-Center, Randomized, Placebo-Controlled, Phase 1, Two-Part Study Designed to Assess 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03140527
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 171 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 10, 2017 (Actual)
- Primary completion
- Feb 27, 2020 (Actual)
- Completion
- Feb 27, 2020 (Actual)
- Last update posted
- Apr 30, 2020
2017 – 2020
United States locations
- U.S. sites
- 33
- U.S. states
- 23
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Providence Alaska Medical Center | Anchorage | Alaska | 99508 | — |
| Stanford University Medical Center | Stanford | California | 94305 | — |
| National Jewish Health | Denver | Colorado | 80206 | — |
| Central Florida Pulmonary Group | Altamonte Springs | Florida | 32803 | — |
| University of Florida College of Medicine | Gainesville | Florida | 32610 | — |
| University of Miami Health System | Miami | Florida | 33136 | — |
| St. Luke's CF Center of Idaho | Boise | Idaho | 83712 | — |
| Northwestern University Memorial Hospital | Chicago | Illinois | 60611 | — |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| Children's Mercy Kansas City | Kansas City | Missouri | 64108 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Children's Lung Specialists | Las Vegas | Nevada | 89107 | — |
| Columbia University Medical Center | New York | New York | 10001 | — |
| Mount Sinai Beth Israel | New York | New York | 10003 | — |
| New York Medical College | Valhalla | New York | 10595 | — |
| Duke University Health System | Durham | North Carolina | 27710 | — |
| Akron Children's Hospital | Akron | Ohio | 44308 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Toledo Children's Hospital | Toledo | Ohio | 43606 | — |
| Santiago Reyes, M.D. P.C. | Oklahoma City | Oklahoma | 73112 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15244 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| ICON Early Phase Services | San Antonio | Texas | 78209 | — |
| University of Texas Health Science Center at Tyler | Tyler | Texas | 75708 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
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 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03140527, 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 Apr 30, 2020 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03140527 live on ClinicalTrials.gov.