A Study of EDG-7500 in Healthy Adults
- Registration Number
- NCT06011317
- Lead Sponsor
- Edgewise Therapeutics, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: Healthy Volunteer (Ages ≥ 18 to < 60 years) Single Ascending Dose EDG-7500 Single oral ascending dose in healthy volunteers ages ≥ 18 to \< 60 years Part A: Healthy Volunteer (Ages ≥ 18 to < 60 years) Single Ascending Dose Placebo Single oral ascending dose in healthy volunteers ages ≥ 18 to \< 60 years Part B: Healthy Volunteer (Ages ≥ 18 to < 60 years) Multiple Ascending Doses EDG-7500 Multiple oral ascending doses in healthy volunteers ages ≥ 18 to \< 60 years Part B: Healthy Volunteer (Ages ≥ 18 to < 60 years) Multiple Ascending Doses Placebo Multiple oral ascending doses in healthy volunteers ages ≥ 18 to \< 60 years Part D: Healthy Volunteer Food Effect and Relative Bioavailability EDG-7500 Crossover food effect (fed versus fasted) single oral dose in healthy volunteers and relative bioavailability of liquid versus solid formulation
- Primary Outcome Measures
Name Time Method Safety: incidence of treatment-emergent adverse events Up to 25 days of monitoring To assess the safety and tolerability of EDG-7500 when administered as single and multiple doses
- Secondary Outcome Measures
Name Time Method Determination of pharmacokinetic parameters as measured by t1/2 Up to 25 days of monitoring Terminal half-life (t1/2)
Determination of pharmacokinetics parameters as measured by Tmax Up to 25 days of monitoring Time to maximum concentration (Tmax)
Determination of renal clearance as measured by CLr Up to 25 days of monitoring Renal clearance (CLr)
Determination of pharmacokinetic parameters as measured by AUC Up to 25 days of monitoring Area under the concentration-time curve (AUC)
Determination of pharmacokinetic parameters as measured by Cmax Up to 25 days of monitoring Maximum observed concentration (Cmax)
Trial Locations
- Locations (1)
Celerion
🇺🇸Lincoln, Nebraska, United States