Healthy VolunteerPhase 1NCT06738836
A Study to Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C]-EDG-7500
A Phase 1 study testing [14C]-EDG-7500 in people with Healthy Volunteer, run by Edgewise Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to: 1. Assess the mass balance (i.e., the cumulative elimination of 14C-related material in urine and feces, compared to the administered amount of radioactive isotope) of [14C]-EDG-7500 following a single oral dose of EDG-7500 containing a radioactive tracer, in healthy, adult male… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- [14C]-EDG-7500
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2024to 17 Jan 2025
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Biological males ≥ 18.0 and < 55.0 years of age at time of providing Informed Consent.
- Body mass index (BMI) ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 at Screening; body weight ≥ 55.0 kg and ≤ 100.0 kg at Screening.
- Subjects with female sexual partner(s) of reproductive potential may be enrolled if the male:
- is documented to be surgically sterile (i.e., successfully vasectomized); or
- agrees to use double-barrier contraception for at least 3 months after receiving study drug and agrees to refrain from sperm donation from the time of Screening through 3 months post dose.
- Negative for hepatitis B surface antigen, hepatitis C virus antibody and human immunodeficiency virus antibody and antigen.
- Non-smoker
Who cannot join
- Clinically significant abnormal medical history, or any abnormal findings on physical examination, vital signs, ECG or laboratory tests at Screening, Admission or predose on Day 1.
- Any history of serious allergic/hypersensitivity reactions.
- History or presence of alcohol or drug abuse within 2 years prior to Screening.
- Recent history of incomplete bladder emptying with voiding or awakening more than once at night to void. Usual habit of < 1 or > 3 bowel movements per day.
- Exposure to radiation for therapeutic or diagnostic reasons (except dental X rays and plain X rays of the thorax and bony skeleton) within the past 12 months .
- Participation in another clinical study in which a [14C]-labeled drug was administered within 1 year prior to Admission.
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- QTcF interval (QT interval corrected for heart rate per Fridericia's formula) > 450 msec at Screening, Admission or predose on Day 1. Personal and family history of long QT syndrome or unexplained sudden death in a first-degree relative under 50 years of age.
- Glomerular filtration rate (GFR) < 80 mL/min/1.73 m2
- Loss or donation of blood (approximately 500 mL or greater) within 60 days prior to study drug administration on Day 1; donation of bone marrow or peripheral stem cells within 90 days prior to study drug administration on Day 1; or donation of plasma within 30 days prior to study drug administration on Day 1.
- Additional protocol defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pharmaron Clinical Pharmacology Center, Inc.
Baltimore, Maryland, 21201
About this study
Official title: An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Metabolism and Excretion of [14C]-EDG-7500 Following Single-Dose Oral Administration
The purpose of this study is to:
- Assess the mass balance (i.e., the cumulative elimination of 14C-related material in urine and feces, compared to the administered amount of radioactive isotope) of [14C]-EDG-7500 following a single oral dose of EDG-7500 containing a radioactive tracer, in healthy, adult male subjects.
- Characterize the pharmacokinetics of EDG-7500 in plasma and of 14C-related material in whole blood, plasma, urine and feces following a single oral dose of EDG-7500 containing a radioactive tracer, in healthy, adult male subjects.
- Conditions
- Healthy Volunteer
- Being tested
- [14C]-EDG-7500
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-EDG-7500Drug
Oral liquid suspension
| Study group | Role | What they receive |
|---|---|---|
| Human AME | Experimental | Not described Receives: Drug: [14C]-EDG-7500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass Balance
Measured: From Day -1 through study completion (up to 19 days)
Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by Cmax
Measured: From Day 1 to study completion (up to 18 days)
Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by Tmax
Measured: From Day 1 to study completion (up to 18 days)
Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by T1/2
Measured: From Day 1 to study completion (up to 18 days)
Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by AUC0-inf
Measured: From Day 1 to study completion (up to 18 days)
Secondary outcomes (2)
Metabolite profile
Measured: From Day -1 through study completion (up to 19 days)
Safety as measured by occurrence of adverse events, clinical laboratory evaluations, 12-lead ECG and vital sign measurements
Measured: From screening through study completion (up to 54 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start3 Dec 2024
- Primary completion17 Jan 2025
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT06738836
- Sponsor's protocol ID
- EDG-7500-104
- Status last verified
- Apr 2025
- First submitted
- 4 Dec 2024
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Metabolism and Excretion of [14C]-EDG-7500 Following Single-Dose Oral Administration
- ClinicalTrials.gov ID
- NCT06738836
- Acronym / sponsor ID
- EDG-7500-104
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Edgewise Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 18 Dec 2024 (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 study is to:
- Assess the mass balance (i.e., the cumulative elimination of 14C-related material in urine and feces, compared to the administered amount of radioactive isotope) of [14C]-EDG-7500 following a single oral dose of EDG-7500 containing a radioactive tracer, in healthy, adult male subjects.
- Characterize the pharmacokinetics of EDG-7500 in plasma and of 14C-related material in whole blood, plasma, urine and feces following a single oral dose of EDG-7500 containing a radioactive tracer, in healthy, adult male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human AME | Experimental | Drug: [14C]-EDG-7500 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Biological males ≥ 18.0 and < 55.0 years of age at time of providing Informed Consent.
- Body mass index (BMI) ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 at Screening; body weight ≥ 55.0 kg and ≤ 100.0 kg at Screening.
- Subjects with female sexual partner(s) of reproductive potential may be enrolled if the male:
- Negative for hepatitis B surface antigen, hepatitis C virus antibody and human immunodeficiency virus antibody and antigen.
- Non-smoker
Key exclusion criteria (10 listed)
- Clinically significant abnormal medical history, or any abnormal findings on physical examination, vital signs, ECG or laboratory tests at Screening, Admission or predose on Day 1.
- Any history of serious allergic/hypersensitivity reactions.
- History or presence of alcohol or drug abuse within 2 years prior to Screening.
- Recent history of incomplete bladder emptying with voiding or awakening more than once at night to void. Usual habit of < 1 or > 3 bowel movements per day.
- Exposure to radiation for therapeutic or diagnostic reasons (except dental X rays and plain X rays of the thorax and bony skeleton) within the past 12 months .
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 |
|---|---|---|
| [14C]-EDG-7500Oral liquid suspension | Drug | Human AME |
Primary outcome
Mass Balance
Time frame: From Day -1 through study completion (up to 19 days)
Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by Cmax
Time frame: From Day 1 to study completion (up to 18 days)
Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by Tmax
Time frame: From Day 1 to study completion (up to 18 days)
Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by T1/2
Time frame: From Day 1 to study completion (up to 18 days)
Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by AUC0-inf
Time frame: From Day 1 to study completion (up to 18 days)
2 secondary outcomes
Metabolite profile
Time frame: From Day -1 through study completion (up to 19 days)
Safety as measured by occurrence of adverse events, clinical laboratory evaluations, 12-lead ECG and vital sign measurements
Time frame: From screening through study completion (up to 54 days)
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 16 Apr 2025.
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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 [14C]-EDG-7500 in people with Healthy Volunteer, 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 16 Apr 2025. 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?
Mass Balance (time frame: From Day -1 through study completion (up to 19 days)). 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 16 Apr 2025.