Safety, Tolerability and Pharmacokinetics of FTX-6058
Public ClinicalTrials.gov record NCT04586985. 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 1 Randomized, Double-Blind, Placebo-Controlled, Single-and Multiple-Dose Study Evaluating Safety, Tolerability, and Pharmacokinetics, With an Open-Label Initial Food Effect and CYP3A Drug-Drug Interaction Study, of FTX-6058 in Healthy Adult Subjects, and a Randomized, Double-Blind, Placebo-Controlled Multiple-Dose Study Evaluating, Safety, Tolerability and Pharmacokinetics in Subjects With Sickle Cell Disease (SCD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a study to evaluate the safety, tolerability and pharmacokinetics of FTX-6058 in healthy adult subjects and adult subjects with sickle cell disease (SCD).
Study identification
- NCT ID
- NCT04586985
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 109 participants
Conditions and interventions
Conditions
Interventions
- FTX-6058/placebo oral capsule(s) Drug
- FTX-6058 - Two Dosing Periods Drug
- FTX-6058 / Midazolam Syrup Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 55 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
- Oct 25, 2020
- Primary completion
- Nov 14, 2022
- Completion
- Nov 14, 2022
- Last update posted
- Dec 11, 2022
2020 – 2022
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Atlanta Center for Medical Research - Sickle Cell Subjects Only | Atlanta | Georgia | 30331 | — |
| Altasciences Clinical Kansas, Inc. - Healthy Adults Subjects Only | Overland Park | Kansas | 66212 | — |
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 NCT04586985, 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 Dec 11, 2022 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04586985 live on ClinicalTrials.gov.