A Study of EDG-7500 in Healthy Adults

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Edgewise Therapeutics, Inc.
Study ID
NCT06011317
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - 59 Years
Healthy Volunteers
Accepted

Interventions

  • EDG-7500 — DRUG
    EDG-7500 is administered orally once daily
  • Placebo — DRUG
    Placebo is administered orally once daily

Study Details

The purposes of this Phase 1 study of EDG-7500 are to: 1. Learn about the safety of EDG-7500 after a single and multiple doses in healthy adults 2. Learn about how EDG-7500 is tolerated after a single and multiples doses in healthy adults 3. Evaluate the amount of EDG-7500 is in the blood and urine after single and multiple doses in healthy adults 4. Evaluate the effect of a meal on the amount of EDG-7500 that is in the blood in healthy adults 5. Evaluate whether the amount of EDG-7500 in the blood is similar for the suspension and tablet forms of EDG-7500 in healthy adults Participants will receive a single or multiple doses of EDG-7500 or a placebo by mouth.

Key Dates

Start date
Aug 14, 2023
Status verified
Jul 2024
Primary completion
May 23, 2024
Completion
Jun 20, 2024

Study Design

Enrollment
84 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Healthy Volunteer (Ages ≥ 18 to < 60 years) Single Ascending Dose
    Single oral ascending dose in healthy volunteers ages ≥ 18 to \< 60 years
  • Experimental: Part B: Healthy Volunteer (Ages ≥ 18 to < 60 years) Multiple Ascending Doses
    Multiple oral ascending doses in healthy volunteers ages ≥ 18 to \< 60 years
  • Experimental: Part D: Healthy Volunteer Food Effect and Relative Bioavailability
    Crossover food effect (fed versus fasted) single oral dose in healthy volunteers and relative bioavailability of liquid versus solid formulation

Primary Outcome Measure

Safety: incidence of treatment-emergent adverse events [ Time Frame: Up to 25 days of monitoring ]

Locations (2)

FacilityCityStateZIPSite coordinators
CelerionTempeArizona85283-
CelerionLincolnNebraska68502-

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