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EDG-7500 for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by Edgewise Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 25 days of monitoring
Awards & highlights

Study Summary

This trial will test the safety, dose, and effect of food on EDG-7500 and its ability to enter the bloodstream in healthy adults.

Who is the study for?
This trial is for healthy adults aged 18 to 72 with a BMI of 18 to <35 kg/m2 and weight ≥55 kg. Participants must have normal health screenings, including ECGs, and not be using prescription meds within the last 4 weeks or non-prescription drugs/supplements within the last 5 days. Pregnant or nursing women, those with breast implants, heavy drinkers, drug users, and nicotine users in the past six months are excluded.Check my eligibility
What is being tested?
The study tests EDG-7500's safety after single/multiple doses in healthy adults. It also examines how well it's tolerated, its presence in blood/urine over time, food effects on absorption levels, and compares suspension vs tablet forms. Participants will take either EDG-7500 or a placebo orally.See study design
What are the potential side effects?
Since this is a Phase 1 trial primarily focused on safety and tolerability of EDG-7500 in humans for the first time, specific side effects are being investigated but are not yet known.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 25 days of monitoring
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 25 days of monitoring for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety: incidence of treatment-emergent adverse events
Secondary outcome measures
Determination of pharmacokinetic parameters as measured by AUC
Determination of pharmacokinetic parameters as measured by Cmax
Determination of pharmacokinetic parameters as measured by t1/2
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part D: Healthy Volunteer Food Effect and Relative BioavailabilityExperimental Treatment1 Intervention
Crossover food effect (fed versus fasted) single oral dose in healthy volunteers and relative bioavailability of liquid versus solid formulation
Group II: Part B: Healthy Volunteer (Ages ≥ 18 to < 60 years) Multiple Ascending DosesExperimental Treatment2 Interventions
Multiple oral ascending doses in healthy volunteers ages ≥ 18 to < 60 years
Group III: Part A: Healthy Volunteer (Ages ≥ 18 to < 60 years) Single Ascending DoseExperimental Treatment2 Interventions
Single oral ascending dose in healthy volunteers ages ≥ 18 to < 60 years
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Edgewise Therapeutics, Inc.Lead Sponsor
11 Previous Clinical Trials
758 Total Patients Enrolled
Medical DirectorStudy DirectorEdgewise Therapeutics, Inc.
2,777 Previous Clinical Trials
8,064,111 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experimental research open to participants older than fifty years?

"This trial is open to patients aged 18 and above, with a maximum age of 72 years old."

Answered by AI

What qualifications are necessary for potential participants in this clinical trial?

"Qualified applicants must be within the ages of 18 and 72, in good health, and there is space for up to 126 volunteers."

Answered by AI

Are there any opportunities for individuals to participate in this experiment?

"On clinicaltrials.gov, it is noted that this study has been actively recruiting since August 14th 2023 and the latest revisions were made on September 6th of the same year."

Answered by AI

Is there a risk associated with Part A: Healthy Volunteer (Ages ≥ 18 to < 60 years) Single Ascending Dose for participants?

"With limited safety and efficacy data, Part A: Healthy Volunteer (Ages ≥ 18 to < 60 years) Single Ascending Dose was given a rating of 1."

Answered by AI

What is the overall size of the cohort participating in this medical experiment?

"Affirmative. According to the clinical trial information posted on clinicaltrials.gov, this research initiative is actively recruiting participants from a single medical site. It was initially published on August 14th 2023 and has been updated most recently on September 6th 2023 with a need of 126 enrollees for the study."

Answered by AI

Who else is applying?

What site did they apply to?
Celerion
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of EDG-7500 in Healthy Adults
2023. "A Study of EDG-7500 in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06011317.
All > Omaha
~29 spots leftby Aug 2024
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