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Safety, Tolerability and Pharmacokinetics of FTX-6058

Phase 1
Waitlist Available
Research Sponsored by Fulcrum Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study part b: days -1, 7, 11-14 and 7-10 days after last dose of study drug

Summary

This trial tests a new drug called FTX-6058 to see if it is safe and how it behaves in healthy adults and adults with sickle cell disease. The study aims to understand its safety, tolerability, and interactions in the body.

Eligible Conditions
  • Healthy Adult Subjects
  • Sickle Cell Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study part b: days -1, 7, 11-14 and 7-10 days after last dose of study drug
This trial's timeline: 3 weeks for screening, Varies for treatment, and study part b: days -1, 7, 11-14 and 7-10 days after last dose of study drug for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Treatment-Emergent Adverse Events
Secondary study objectives
Plasma Concentrations of FTX-6058
Plasma Concentrations of Midazolam
Plasma Concentrations of for 1-OH-Midazolam
Other study objectives
Predictive Model of the Relationship between FTX-6058 Concentration and QTc Intervals
Target Engagement of FTX-6058

Trial Design

5Treatment groups
Experimental Treatment
Group I: Single Ascending Dose (SAD) cohorts in Healthy Subjects (Part A)Experimental Treatment1 Intervention
Subjects will be randomized to receive a single dose of FTX-6058 or placebo. Cohorts 1 and 2 will enroll 5 subjects per cohort randomized 3:2. Cohorts 3-8 will enroll 7 subjects per cohort randomized 5:2. Planned doses are 2 mg (Cohort 1), 4 mg (Cohort 2), 10 mg (Cohort 3), 20 mg (Cohort 4), 30 mg (Cohort 5), 40 mg (Cohort 6), 60 mg (Cohort 7), and 90 mg (Cohort 8).
Group II: Potential for CYP3A Induction in Healthy Subjects (Part D)Experimental Treatment1 Intervention
Sixteen subjects will receive 3 mg Midazolam once by mouth on Day 1. On Days 3-12, subjects will receive FTX-6058 by mouth once daily. On Day 12, a second dose of 3 mg Midazolam will be given once by mouth. The dose of FTX-6058 will be the highest tolerated dose from Part B.
Group III: Pilot Food Effect Cohort in Healthy Subjects (Part C)Experimental Treatment1 Intervention
Ten subjects will be randomized to receive a single 20 mg dose of FTX-6058 with and without a high-fat meal with a washout period of 4 days.
Group IV: Multiple Dose Cohort in Sickle Cell Disease Subjects (Part E)Experimental Treatment1 Intervention
Subjects will be randomized 3:1 to receive FTX-6058 or placebo once daily by mouth for 14 days. Up to 8 subjects will be enrolled. The planned dose is 6mg.
Group V: Multiple Ascending Dose (MAD) cohorts in Healthy Subjects (Part B)Experimental Treatment1 Intervention
Subjects will be randomized 3:1 to receive once daily FTX-6058 or placebo by mouth for 14 days. Up to 6 cohorts of 8 subjects per cohort will be enrolled. Planned doses are 2 mg (Cohort 1), 6 mg (Cohort 2), 10 mg (Cohort 3), 20 mg (Cohort 4), 30 mg (Cohort 5), and 40 mg (Cohort 6).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FTX-6058/placebo oral capsule(s)
2020
Completed Phase 1
~110
FTX-6058 - Two Dosing Periods
2020
Completed Phase 1
~110
FTX-6058 / Midazolam Syrup
2020
Completed Phase 1
~110

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Fulcrum TherapeuticsLead Sponsor
7 Previous Clinical Trials
570 Total Patients Enrolled
John Ziegler, MD, FASAStudy DirectorFulcrum Therapeutics
2 Previous Clinical Trials
122 Total Patients Enrolled
~21 spots leftby Dec 2025