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Safety, Tolerability and Pharmacokinetics of FTX-6058

NCT04586985 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2022-12-12

No results posted yet for this 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).

Conditions

Interventions

DRUG

FTX-6058/placebo oral capsule(s)

Subjects will receive FTX-6058 or matching placebo.

DRUG

FTX-6058/placebo oral capsule(s)

Subjects will receive FTX-6058 or matching placebo.

DRUG

FTX-6058 - Two Dosing Periods

Subjects will receive FTX-6058

DRUG

FTX-6058 / Midazolam Syrup

Subjects will receive FTX-6058 and midazolam syrup

DRUG

FTX-6058/placebo oral capsule(s)

Subjects will receive FTX-6058 or matching placebo.

Sponsors & Collaborators

  • Fulcrum Therapeutics

    lead INDUSTRY

Principal Investigators

  • John Ziegler, MD, FASA · Fulcrum Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-26
Primary Completion
2022-11-15
Completion
2022-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04586985 on ClinicalTrials.gov