A Study of EDG-7500 in Healthy Adults

Study Overview
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Brief Summary
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The purposes of this Phase 1 study of EDG-7500 are to: Learn about the safety of EDG-7500 after a single and multiple doses in healthy adults Learn about how EDG-7500 is tolerated after a single and multiples doses in healthy adults Evaluate the amount of EDG-7500 is in the blood and urine after single and multiple doses in healthy adults Evaluate the effect of a meal on the amount of EDG-7500 that is in the blood in healthy adults 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.

Official Title
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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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: EDG-7500
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to give informed consent and follow all study procedures and requirements. Healthy male or nonpregnant female, ages ≥ 18 to ≤ 72 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: Healthy Volunteer (Ages ≥ 18 to < 60 years) Single Ascending Dose<br>Single oral ascending dose in healthy volunteers ages ≥ 18 to < 60 years | Drug: EDG-7500<br>* EDG-7500 is administered orally once daily<br>Drug: Placebo<br>* Placebo is administered orally once daily<br>|
| Experimental: Part B: Healthy Volunteer (Ages ≥ 18 to < 60 years) Multiple Ascending Doses<br>Multiple oral ascending doses in healthy volunteers ages ≥ 18 to < 60 years | Drug: EDG-7500<br>* EDG-7500 is administered orally once daily<br>Drug: Placebo<br>* Placebo is administered orally once daily<br>|
| Experimental: Part C: Healthy Volunteers (Ages ≥ 60 to ≤ 72 years) Multiple Ascending Doses<br>Multiple oral ascending doses in healthy volunteers ages ≥ 60 to ≤ 72 years | Drug: EDG-7500<br>* EDG-7500 is administered orally once daily<br>Drug: Placebo<br>* Placebo is administered orally once daily<br>|
| Experimental: Part D: Healthy Volunteer Food Effect and Relative Bioavailability<br>Crossover food effect (fed versus fasted) single oral dose in healthy volunteers and relative bioavailability of liquid versus solid formulation | Drug: EDG-7500<br>* EDG-7500 is administered orally once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: incidence of treatment-emergent adverse events | To assess the safety and tolerability of EDG-7500 when administered as single and multiple doses | Up to 25 days of monitoring | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of pharmacokinetics parameters as measured by Tmax | Time to maximum concentration (Tmax) | Up to 25 days of monitoring | 
| Determination of pharmacokinetic parameters as measured by Cmax | Maximum observed concentration (Cmax) | Up to 25 days of monitoring | 
| Determination of pharmacokinetic parameters as measured by AUC | Area under the concentration-time curve (AUC) | Up to 25 days of monitoring | 
| Determination of pharmacokinetic parameters as measured by t1/2 | Terminal half-life (t1/2) | Up to 25 days of monitoring | 
| Determination of renal clearance as measured by CLr | Renal clearance (CLr) | Up to 25 days of monitoring |