A Study of EDG-7500 in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-14

Study Completion Date

2024-06-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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

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

Group Type EXPERIMENTAL

EDG-7500

Intervention Type DRUG

EDG-7500 is administered orally once daily

Placebo

Intervention Type DRUG

Placebo is administered orally once daily

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

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

Group Type EXPERIMENTAL

EDG-7500

Intervention Type DRUG

EDG-7500 is administered orally once daily

Placebo

Intervention Type DRUG

Placebo is administered orally once daily

Part D: Healthy Volunteer Food Effect and Relative Bioavailability

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

Group Type EXPERIMENTAL

EDG-7500

Intervention Type DRUG

EDG-7500 is administered orally once daily

Interventions

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EDG-7500

EDG-7500 is administered orally once daily

Intervention Type DRUG

Placebo

Placebo is administered orally once daily

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes