Healthy Adult ParticipantsPhase 1NCT07456059
A Study to Evaluate EDG-7500 in Caucasian and Japanese Adults
A Phase 1 study testing EDG-7500 in people with Healthy Adult Participants, run by Edgewise Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of this Phase 1 study is to understand and compare the amount of EDG-7500 in the blood after single and multiple doses in Japanese and Caucasian adults. The safety of EDG-7500 in these adult participants will also be evaluated in this study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- EDG-7500
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2026to 1 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult, male or female, 18-55 years of age, inclusive.
- Medically healthy based on a medical evaluation (including medical history, physical examination, vital signs measurement, 12-lead ECG, and clinical laboratory evaluations) performed at screening.
- Meets the protocol-specified criteria to qualify as a Japanese or Caucasian participant.
- BMI ≥ 18.0 and ≤ 35.0 kg/m2 at screening.
- Heart rate ≥ 45 and ≤ 99 bpm, systolic blood pressure ≥90 and <140 mmHg, and diastolic blood pressure ≥ 50 to ≤ 90 mmHg at screening.
- eGFR ≥ 80 mL/min/1.73 m2 calculated using the CKD-EPI formula at screening.
- Female and male participants must follow protocol-specified contraception guidance.
Who cannot join
- History or evidence of any clinically significant cardiovascular, dermatologic, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, neurologic, psychiatric, pulmonary, renal, respiratory, and/or other major disorders or malignancy.
- History or evidence of any disorder that may interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or human immunodeficiency virus (HIV).
- History of significant blood loss, donation of blood, or received a transfusion of any blood or blood products within 60 days prior to screening.
- History of plasma donation within 7 days prior to screening.
- History of use of tobacco- or nicotine-containing products within six months prior to screening.
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- Participating in another interventional clinical study or has used an investigational drug within 30 days or 5 half-lives prior to screening.
- History of alcohol and/or illicit drug abuse within 2 years of study participation.
- Positive urine test for alcohol or a positive urine drug test at screening or check-in.
- Breastfeeding or has a positive serum pregnancy test at screening or check-in.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-center, Open-label, Study to Investigate the Safety, Tolerability, and Pharmacokinetics of a Single Dose and Multiple Doses of EDG-7500 in Healthy Adult Caucasian and Japanese Participants
The purpose of this Phase 1 study is to understand and compare the amount of EDG-7500 in the blood after single and multiple doses in Japanese and Caucasian adults. The safety of EDG-7500 in these adult participants will also be evaluated in this study.
- Conditions
- Healthy Adult Participants
- Being tested
- EDG-7500
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDG-7500Drug
Solid oral formulation of EDG-7500
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Healthy Japanese Adults | Experimental | Single and Multiple Dose EDG-7500 Receives: Drug: EDG-7500 |
| Cohort 2 - Healthy Japanese Adults | Experimental | Single and Multiple Dose EDG-7500 Receives: Drug: EDG-7500 |
| Cohort 3 - Healthy Caucasian Adults | Experimental | Single and Multiple Dose EDG-7500 Receives: Drug: EDG-7500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-last
Area under the plasma concentration time-curve from time zero to the last measured concentration
Measured: Day 1 to Day 13
AUC0-inf
Area under the plasma concentration time-curve from time zero extrapolated to infinity
Measured: Day 1 to Day 13
AUCtau
Area under the concentration-time curve during the dosing interval
Measured: Day 1 to Day 13
Cmax
Maximum plasma concentration observed
Measured: Day 1 to Day 13
Cmax,ss
Maximum plasma concentration at steady state determined directly from the concentration-time profile
Measured: Day 1 to Day 13
Secondary outcomes (10)
Safety - TEAEs
Incidence of treatment-emergent adverse events
Measured: Up to 23 days of monitoring
Tmax
Time to maximum plasma concentration
Measured: Day 1 to Day 13
AUC%extrap
Percentage of AUCinf obtained by extrapolation beyond time of the last quantifiable concentration (tlast)
Measured: Day 1 to Day 13
CL/F
Total body clearance
Measured: Day 1 to Day 13
Vz/F
Apparent volume of distribution
Measured: Day 1 to Day 13
T1/2
Terminal elimination half-life
Measured: Day 1 to Day 13
Ctrough,ss
Trough plasma concentration at steady state
Measured: Day 1 to Day 13
Cavg,ss
Average plasma drug concentration during a dosing interval at steady state
Measured: Day 1 to Day 13
RA(AUCtau)
Accumulation ratio for the area under the concentration-time curve during the dosing interval
Measured: Day 1 to Day 13
RA(Cmax)
Accumulation ratio at the maximum concentration
Measured: Day 1 to Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start10 Mar 2026
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edgewise Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456059
- Sponsor's protocol ID
- EDG-7500-107
- Status last verified
- Jul 2026
- First submitted
- 3 Mar 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-center, Open-label, Study to Investigate the Safety, Tolerability, and Pharmacokinetics of a Single Dose and Multiple Doses of EDG-7500 in Healthy Adult Caucasian and Japanese Participants
- ClinicalTrials.gov ID
- NCT07456059
- Acronym / sponsor ID
- EDG-7500-107
- Conditions
- Healthy Adult Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Edgewise Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this Phase 1 study is to understand and compare the amount of EDG-7500 in the blood after single and multiple doses in Japanese and Caucasian adults. The safety of EDG-7500 in these adult participants will also be evaluated in this study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Healthy Japanese Adults | Experimental | Drug: EDG-7500Single and Multiple Dose EDG-7500 |
| Cohort 2 - Healthy Japanese Adults | Experimental | Drug: EDG-7500Single and Multiple Dose EDG-7500 |
| Cohort 3 - Healthy Caucasian Adults | Experimental | Drug: EDG-7500Single and Multiple Dose EDG-7500 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adult, male or female, 18-55 years of age, inclusive.
- Medically healthy based on a medical evaluation (including medical history, physical examination, vital signs measurement, 12-lead ECG, and clinical laboratory evaluations) performed at screening.
- Meets the protocol-specified criteria to qualify as a Japanese or Caucasian participant.
- BMI ≥ 18.0 and ≤ 35.0 kg/m2 at screening.
- Heart rate ≥ 45 and ≤ 99 bpm, systolic blood pressure ≥90 and <140 mmHg, and diastolic blood pressure ≥ 50 to ≤ 90 mmHg at screening.
Key exclusion criteria (10 listed)
- History or evidence of any clinically significant cardiovascular, dermatologic, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, neurologic, psychiatric, pulmonary, renal, respiratory, and/or other major disorders or malignancy.
- History or evidence of any disorder that may interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or human immunodeficiency virus (HIV).
- History of significant blood loss, donation of blood, or received a transfusion of any blood or blood products within 60 days prior to screening.
- History of plasma donation within 7 days prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDG-7500Solid oral formulation of EDG-7500 | Drug | Cohort 1 - Healthy Japanese Adults, Cohort 2 - Healthy Japanese Adults, Cohort 3 - Healthy Caucasian Adults |
Primary outcome
AUC0-last
Time frame: Day 1 to Day 13
Area under the plasma concentration time-curve from time zero to the last measured concentration
AUC0-inf
Time frame: Day 1 to Day 13
Area under the plasma concentration time-curve from time zero extrapolated to infinity
AUCtau
Time frame: Day 1 to Day 13
Area under the concentration-time curve during the dosing interval
Cmax
Time frame: Day 1 to Day 13
Maximum plasma concentration observed
Cmax,ss
Time frame: Day 1 to Day 13
Maximum plasma concentration at steady state determined directly from the concentration-time profile
10 secondary outcomes
Safety - TEAEs
Time frame: Up to 23 days of monitoring
Tmax
Time frame: Day 1 to Day 13
AUC%extrap
Time frame: Day 1 to Day 13
CL/F
Time frame: Day 1 to Day 13
Vz/F
Time frame: Day 1 to Day 13
T1/2
Time frame: Day 1 to Day 13
Ctrough,ss
Time frame: Day 1 to Day 13
Cavg,ss
Time frame: Day 1 to Day 13
RA(AUCtau)
Time frame: Day 1 to Day 13
RA(Cmax)
Time frame: Day 1 to Day 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EDG-7500 in people with Healthy Adult Participants, run by Edgewise Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-last (time frame: Day 1 to Day 13). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.