Healthy Subjects
Conditions
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.
Interventions
DRUGEDG-7500
EDG-7500 is administered orally once daily
DRUGPlacebo
Placebo is administered orally once daily
Sponsors
Edgewise Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
1. Willing and able to give informed consent and follow all study procedures and requirements. 2. Healthy male or nonpregnant female, ages ≥ 18 to \< 60 years. 3. Body mass index (BMI) ≥ 18 to \< 35 kg/m2; weight ≥ 55 kg at Screening. 4. Absence of important health problems and essentially normal physical examination, normal laboratory screening tests, and normal electrocardiogram (ECG) with QTcF ≤ 450 ms.
Exclusion criteria
1. Evidence of clinically significant abnormalities or disease. 2. 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. 3. Donation or loss of \> 1 unit (450 mL) of blood ≤ 1 month prior to dosing. 4. Females: nursing, lactating, or pregnant. 5. Females: breast implants. 6. Use of nicotine-containing products in the last 6 months prior to dosing. 7. 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Determination of pharmacokinetics parameters as measured by Tmax | Up to 25 days of monitoring | Time to maximum concentration (Tmax) |
| Determination of pharmacokinetic parameters as measured by Cmax | Up to 25 days of monitoring | Maximum observed concentration (Cmax) |
| 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 t1/2 | Up to 25 days of monitoring | Terminal half-life (t1/2) |
| Determination of renal clearance as measured by CLr | Up to 25 days of monitoring | Renal clearance (CLr) |
Countries
United States
Outcome results
None listed