Clinical trial NCT06011317: A Study of EDG-7500 in Healthy Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Edgewise Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-25
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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/exclusion criteria may apply.

Primary outcomes:
measure: Safety: incidence of treatment-emergent adverse events
timeFrame: Up to 25 days of monitoring
Secondary outcomes:
measure: Determination of pharmacokinetics parameters as measured by Tmax
timeFrame: Up to 25 days of monitoring
measure: Determination of pharmacokinetic parameters as measured by Cmax
timeFrame: Up to 25 days of monitoring
measure: Determination of pharmacokinetic parameters as measured by AUC
timeFrame: Up to 25 days of monitoring
measure: Determination of pharmacokinetic parameters as measured by t1/2
timeFrame: Up to 25 days of monitoring
measure: Determination of renal clearance as measured by CLr
timeFrame: Up to 25 days of monitoring
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
affiliation: Edgewise Therapeutics, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: