Healthy Adults
Conditions
Brief summary
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.
Interventions
DRUGEDG-15400
EDG-15400 is administered orally
DRUGPlacebo
Placebo is administered orally
Sponsors
Edgewise Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
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) ≥18.5 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 QTc interval corrected for heart rate using the Fridericia method (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 within the last 2 years. 8. Alcohol consumption \> 14 drinks per week for males (7 for females) within 45 days of screening. 9. Positive screen for drugs of abuse or alcohol or nicotine exposure 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 45 days of monitoring | To determine the safety and tolerability of EDG-15400 when administered as single and multiple ascending doses to healthy adults |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determination of Tmax | Up to 38 days | Time to maximum concentration (Tmax) |
| Determination of Cmax | Up to 38 days | Maximum observed concentration (Cmax) |
| Determination of AUC | Up to 38 days | Area under the concentration-time curve (AUC) |
| Determination of t1/2 | Up to 38 days | Elimination half-life (t1/2) |
| Determination of V/F | Up to 38 days | Apparent volume of distribution after oral administration (V/F) |
| Determination of CL/F | Up to 38 days | Apparent clearance of drug after oral administration (CL/F) |
| Determination of CLr | Up to 38 days | Renal clearance (CLr) |
Countries
United States
Outcome results
None listed