Actively Recruiting
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability, and Pharmacokinetics of EDG-15400 in Healthy Adults
Led by Edgewise Therapeutics, Inc. · Updated on 2025-09-16
108
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 1 study to evaluate EDG-15400 in healthy adults aged 18 to under 60 years. The study aims to learn about the safety, tolerability, and how the drug behaves in the body after single and multiple doses. It also assesses the effect of food on the drug's levels in the blood and compares the suspension and tablet forms of EDG-15400. Participants will receive either single or multiple oral doses of EDG-15400 or a placebo. The study includes three parts: a single ascending dose in fasting adults, multiple ascending doses once daily in fasting adults, and a crossover phase to study food effects and relative bioavailability between liquid and solid forms. During the study, participants will be monitored for up to 25 days to track treatment-emergent adverse events and measure drug levels in blood and urine. Assessments include determining timing and concentration measures such as Tmax, Cmax, AUC, half-life, volume of distribution, and clearance rates. Safety and pharmacokinetic data will guide understanding of EDG-15400's effects in healthy adults.
CONDITIONS
Brief Title
A Study of EDG-15400 in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to give informed consent and follow all study procedures and requirements.
- Healthy male or nonpregnant female, ages 18 to less than 60 years.
- Body mass index (BMI) between 18.5 and less than 35 kg/m2.
- Weight at least 55 kg at screening.
- No significant health problems with normal physical exam, lab tests, and ECG including QTcF less than or equal to 450 ms.
You will not qualify if you...
- Any clinically significant abnormalities or diseases.
- Use of any prescription medication within 4 weeks or investigational medication within 12 weeks or 5 half-lives before dosing unless permitted.
- Use of any non-prescription medication or herbal/nutritional supplements within 5 days before dosing.
- Blood donation or loss of more than 1 unit (450 mL) within 1 month before dosing.
- Females who are nursing, lactating, or pregnant.
- Females with breast implants.
- Use of nicotine-containing products within 6 months before dosing.
- History of substance abuse or recreational drug use within the last 2 years.
- Alcohol consumption exceeding 14 drinks per week for males or 7 drinks per week for females within 45 days of screening.
- Positive drug, alcohol, or nicotine tests at screening or admission.
Additional protocol defined criteria may apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 25 days
Participants receive single or multiple oral doses of EDG-15400 or placebo under different conditions to evaluate safety and pharmacokinetics.
Visits scheduled according to dosing and assessments during treatment
Trial Site Locations
Total: 1 location
1
Celerion, Inc.
Tempe, Arizona, United States, 85283
Actively Recruiting
Research Team
C
Contact: Edgewise Therapeutics, Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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