A SAD/MAD to Assess the Safety, PK/PD of FT-4202 in Healthy Volunteers and Sickle Cell Disease Patients
Public ClinicalTrials.gov record NCT03815695. 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 Randomized, Placebo-controlled, Double Blind, Single Ascending and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of FT-4202 in Healthy Volunteers and Sickle Cell Disease Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
FT-4202 is an oral small-molecule agonist of pyruvate kinase red blood cell isozyme (PKR) being developed for the treatment of hemolytic anemias. This initial study will characterize the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of a single ascending dose and multiple ascending doses of FT-4202 in the context of Phase 1 studies in healthy volunteers and sickle cell disease patients. The effects of food on the absorption of FT-4202 will also be evaluated in healthy volunteers.
Study identification
- NCT ID
- NCT03815695
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 130 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 65 Years
- 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
- Dec 11, 2018 (Actual)
- Primary completion
- Dec 17, 2021 (Actual)
- Completion
- Dec 17, 2021 (Actual)
- Last update posted
- Apr 10, 2024
2018 – 2021
United States locations
- U.S. sites
- 18
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Woodland International Research Group (SCD subjects only) | Little Rock | Arkansas | 72211 | — |
| Collaborative Neuroscience Research, LLC (SCD subjects only) | Long Beach | California | 90806 | — |
| Pacific Research Partners (SCD subjects only) | Oakland | California | 94607 | — |
| UCSF Benioff Children's Hospital Oakland (SCD subjects only) | Oakland | California | 94609 | — |
| Advanced Pharma CR, LLC (SCD subjects only) | Miami | Florida | 33147 | — |
| Children's Healthcare of Atlanta (SCD subjects only) | Atlanta | Georgia | 30342 | — |
| Augusta University Medical Center (SCD subjects only) | Augusta | Georgia | 30912 | — |
| University of Illinois at Chicago (SCD subjects only) | Chicago | Illinois | 60612 | — |
| University of Maryland, Greenebaum Comprehensive Cancer Center (SCD subjects only) | Baltimore | Maryland | 21201 | — |
| Columbia University Medical Center (SCD subjects only) | New York | New York | 10032 | — |
| Levine Cancer Institute (SCD subjects only) | Charlotte | North Carolina | 28204 | — |
| Duke University Medical Center (SCD subjects only) | Durham | North Carolina | 27710 | — |
| University of Cincinnati Medical Center (SCD subjects only) | Cincinnati | Ohio | 45219 | — |
| Medpace Clinical Pharmacology Unit (Healthy Volunteers only) | Cincinnati | Ohio | 45227 | — |
| Cincinnati Children's Hospital Medical Center (SCD subjects only) | Cincinnati | Ohio | 45229 | — |
| Lynn Institute of Tulsa (SCD subjects only) | Tulsa | Oklahoma | 74135 | — |
| St. Jude Children's Research Hospital (SCD subjects only) | Memphis | Tennessee | 38105 | — |
| The University of Texas Health Science Center at Houston (SCD subjects only) | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03815695, 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 10, 2024 · Synced Nov 3, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03815695 live on ClinicalTrials.gov.