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NCT Number: NCT07177066

A Study of EDG-15400 in Healthy Adults

The purposes of this Phase 1 study of EDG-15400 are to:

1. Learn about the safety of EDG-15400 after single and multiple doses in healthy adults 2. Learn about how EDG-15400 is tolerated after single and multiples doses in healthy adults 3. Evaluate the amount of EDG-15400 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-15400 that is in the blood in healthy adults 5. Evaluate whether the amount of EDG-15400 in the blood is similar for the suspension and tablet forms of EDG-15400 in healthy adults

Participants will receive a single or multiple doses of EDG-15400 or a placebo by mouth.

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Key information

Conditions

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Inc.

Tempe, Arizona, 85283, United States

Location status: Recruiting

Location contact

Edgewise Therapeutics, Inc.

CONTACT

720-262-7002

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing and able to give informed consent and follow all study procedures and requirements.
  • Healthy male or nonpregnant female, ages ≥18 to <60 years.
  • Body mass index (BMI) ≥18.5 to <35 kg/m2; weight ≥55 kg at Screening.
  • Absence of important health problems and essentially normal physical examination, normal laboratory screening tests, and normal electrocardiogram (ECG) with QTc interval corrected for heart rate using the Fridericia method (QTcF) ≤450 ms.

Exclusion criteria

  • Evidence of clinically significant abnormalities or disease.
  • Unless permitted by protocol, use of any prescription medication ≤ 4 weeks or investigational medication ≤ 12 weeks or ≤ 5 half-lives (whichever is longer) of dosing. Use of any non-prescription medication or herbal/nutritional supplement ≤ 5 days prior to dosing.
  • Donation or loss of > 1 unit (450 mL) of blood ≤ 1 month prior to dosing.
  • Females: nursing, lactating, or pregnant.
  • Females: breast implants.
  • Use of nicotine-containing products in the last 6 months prior to dosing.
  • History of substance abuse or dependency or history of recreational drug use within the last 2 years.
  • Alcohol consumption > 14 drinks per week for males (7 for females) within 45 days of screening.
  • Positive screen for drugs of abuse or alcohol or nicotine exposure test at Screening or Admission.

Additional protocol defined inclusion/exclusion criteria may apply.

Treatment and study plan

EDG-15400

Drug

EDG-15400 is administered orally

Placebo

Drug

Placebo is administered orally

Primary outcomes

  1. Safety: incidence of treatment-emergent adverse events

    Time frame: Up to 25 days of monitoring

    To determine the safety and tolerability of EDG-15400 when administered as single and multiple ascending doses to healthy adults

Secondary outcomes

  1. Determination of Tmax

    Time frame: Up to 25 days

    Time to maximum concentration (Tmax)

  2. Determination of Cmax

    Time frame: Up to 25 days

    Maximum observed concentration (Cmax)

  3. Determination of AUC

    Time frame: Up to 25 days

    Area under the concentration-time curve (AUC)

  4. Determination of t1/2

    Time frame: Up to 25 days

    Elimination half-life (t1/2)

  5. Determination of V/F

    Time frame: Up to 25 days

    Apparent volume of distribution after oral administration (V/F)

  6. Determination of CL/F

    Time frame: Up to 25 days

    Apparent clearance of drug after oral administration (CL/F)

  7. Determination of CLr

    Time frame: Up to 25 days

    Renal clearance (CLr)

Study contacts

Contact information is provided by the study sponsor or research team.

Contact: Edgewise Therapeutics, Inc.

CONTACT

[email protected]

720-262-7002

Sponsors and collaborators

Lead sponsor

Edgewise Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-15400 in Healthy Adults

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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