A Study of EDG-7500 in Healthy Adults

NCT06011317 | Completed Phase 1 FDA Drug

• 1 other identifier: EDG-7500-101
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief Summary

The purposes of this Phase 1 study of EDG-7500 are to:

1. 1.Learn about the safety of EDG-7500 after a single and multiple doses in healthy adults
2. 2.Learn about how EDG-7500 is tolerated after a single and multiples doses in healthy adults
3. 3.Evaluate the amount of EDG-7500 is in the blood and urine after single and multiple doses in healthy adults
4. 4.Evaluate the effect of a meal on the amount of EDG-7500 that is in the blood in healthy adults
5. 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

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Determination of pharmacokinetics parameters as measured by Tmax

  Up to 25 days of monitoring

• Determination of pharmacokinetic parameters as measured by Cmax

  Up to 25 days of monitoring

• Determination of pharmacokinetic parameters as measured by AUC

  Up to 25 days of monitoring

• Determination of pharmacokinetic parameters as measured by t1/2

  Up to 25 days of monitoring

• Determination of renal clearance as measured by CLr

  Up to 25 days of monitoring

Study Arms (3)

Part A: Healthy Volunteer (Ages ≥ 18 to < 60 years) Single Ascending Dose

EXPERIMENTAL

Single oral ascending dose in healthy volunteers ages ≥ 18 to \< 60 years

Drug: EDG-7500; Drug: Placebo

Part B: Healthy Volunteer (Ages ≥ 18 to < 60 years) Multiple Ascending Doses

EXPERIMENTAL

Multiple oral ascending doses in healthy volunteers ages ≥ 18 to \< 60 years

Drug: EDG-7500; Drug: Placebo

Part D: Healthy Volunteer Food Effect and Relative Bioavailability

EXPERIMENTAL

Crossover food effect (fed versus fasted) single oral dose in healthy volunteers and relative bioavailability of liquid versus solid formulation

Drug: EDG-7500

Interventions

EDG-7500 DRUG

EDG-7500 is administered orally once daily

Part A: Healthy Volunteer (Ages ≥ 18 to < 60 years) Single Ascending Dose; Part B: Healthy Volunteer (Ages ≥ 18 to < 60 years) Multiple Ascending Doses; Part D: Healthy Volunteer Food Effect and Relative Bioavailability

Placebo DRUG

Placebo is administered orally once daily

Part A: Healthy Volunteer (Ages ≥ 18 to < 60 years) Single Ascending Dose; Part B: Healthy Volunteer (Ages ≥ 18 to < 60 years) Multiple Ascending Doses

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing and able to give informed consent and follow all study procedures and requirements.
• Healthy male or nonpregnant female, ages ≥ 18 to \< 60 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edgewise Therapeutics, Inc.: lead

Study Sites (2)

Celerion

Tempe, Arizona, 85283, United States

Location

Celerion

Lincoln, Nebraska, 68502, United States

Location

Study Officials

• Medical Director

  Edgewise Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: August 25, 2023
• Study Start: August 14, 2023
• Primary Completion: May 23, 2024
• Study Completion: June 20, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)