Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04586985 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Pharmacokinetics of FTX-6058
A Phase 1 study, sponsored by Fulcrum Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 109
- Enrollment target
NCT04586985: Completed Phase 1 study, sponsored by Fulcrum Therapeutics.
NCT04586985 is a Phase 1 study that has completed, run by Fulcrum Therapeutics. The registered enrollment target is 109 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04586985, a Phase 1 study, has completed, sponsored by Fulcrum Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 109 participants
- Enrollment target
Study Summary
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).
Primary Outcome
To evaluate the safety and tolerability of FTX-6058 in healthy adult subjects and adult subjects with sickle cell disease based on the frequency of adverse events (AEs), frequency of serious adverse events (SAEs), and clinically significant laboratory test results, electrocardiograms (ECGs), and vital signs.
Interventions
- DRUG FTX-6058/placebo oral capsule(s)
- DRUG FTX-6058 - Two Dosing Periods
- DRUG FTX-6058 / Midazolam Syrup
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2020-10-26 |
| Est. Completion | 2022-11-15 |
| Phase | Phase 1 |
What the finished NCT04586985 record still lists
NCT04586985 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% higher).
The record links to 0 conditions, and to 3 interventions - of which FTX-6058/placebo oral capsule(s) is the first listed.
NCT04586985 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04586985 about?
NCT04586985 is a clinical study titled "Safety, Tolerability and Pharmacokinetics of FTX-6058". 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).
What is the current status of trial NCT04586985?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 109 participants. The study started on 2020-10-26. Estimated completion is 2022-11-15.
What interventions are being tested in trial NCT04586985?
The interventions under investigation include: FTX-6058/placebo oral capsule(s) (DRUG), FTX-6058 - Two Dosing Periods (DRUG), FTX-6058 / Midazolam Syrup (DRUG).
Who is sponsoring clinical trial NCT04586985?
This trial is sponsored by Fulcrum Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04586985's enrollment target sits among peer trials
109 522nd of 2000 higher than 1,478 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02421380 · 109 participants · NA
Characterization of Hyperpolarized Pyruvate MRI Reproducibility
- NCT04526600 · 109 participants · NA
Fidgeting and Attentional and Emotional Regulation in ADHD
- NCT04835584 · 109 participants · Phase 1
KRT-232 and TKI Study in Chronic Myeloid Leukemia
- NCT06626516 · 109 participants · Phase 1
Tebentafusp-tebn With LDT in Metastatic UM
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI