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Completed

NCT Number: NCT06011317

A Study of EDG-7500 in Healthy Adults

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.

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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, Tempe, Arizona, United States

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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 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 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. Alcohol consumption > 14 drinks per week for males (7 for females). Positive screen for drugs of abuse or alcohol or cotinine test at Screening or Admission.

Additional protocol defined inclusion/exclusion criteria may apply.

Treatment and study plan

EDG-7500

Drug

EDG-7500 is administered orally once daily

Placebo

Drug

Placebo is administered orally once daily

Primary outcomes

  1. Safety: incidence of treatment-emergent adverse events

    Time frame: Up to 25 days of monitoring

    To assess the safety and tolerability of EDG-7500 when administered as single and multiple doses

Secondary outcomes

  1. Determination of pharmacokinetics parameters as measured by Tmax

    Time frame: Up to 25 days of monitoring

    Time to maximum concentration (Tmax)

  2. Determination of pharmacokinetic parameters as measured by Cmax

    Time frame: Up to 25 days of monitoring

    Maximum observed concentration (Cmax)

  3. Determination of pharmacokinetic parameters as measured by AUC

    Time frame: Up to 25 days of monitoring

    Area under the concentration-time curve (AUC)

  4. Determination of pharmacokinetic parameters as measured by t1/2

    Time frame: Up to 25 days of monitoring

    Terminal half-life (t1/2)

  5. Determination of renal clearance as measured by CLr

    Time frame: Up to 25 days of monitoring

    Renal clearance (CLr)

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 of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-7500 in Healthy Adults

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 25, 2023
Registry last updated
Jul 16, 2024

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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