Healthy ParticipantsPhase 1NCT06645704
An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Metabolism and Excretion of [14C]-EP262 Following Single-Dose Oral Administration
A Phase 1 study testing EP262 in people with Healthy Participants, run by Escient Pharmaceuticals, Inc at 1 site in United States.
Trial summary
This study is being conducted to assess the mass balance, pharmacokinetics, and metabolite profiles of a single oral dose of [14C]-EP262 in healthy male participants. 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 Participants
- What is being tested?
- EP262
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 10 Dec 2024
- 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
- Males aged 18 to 55 years
- Body mass index of 18 to 32 kg/m2 and body weight of 55 to 100 kg
- Negative result for HIV, HBV, and HCV at Screening
- Male subjects with female partners of reproductive potential must be surgically sterile or use adequate birth control
- No use of tobacco or nicotine containing products within the past 6 months
Who cannot join
- History or presence of any condition or prior surgery that could pose a significant risk in the opinion of the investigator
- History of malignancy within the past 5 years
- History of any serious allergic reactions or hypersensitivity
- Recent history of incomplete bladder emptying with voiding or awakening more than once at a night to void
- Usual habit of bowel movements of less than 1 or more than 3 bowel movements per day
Trial locations and contacts
1 site in 1 country.
United States1 site
Pharmaron Clinical Pharmacology Center (CPC)
Baltimore, Maryland, 21201
About this study
This study is being conducted to assess the mass balance, pharmacokinetics, and metabolite profiles of a single oral dose of [14C]-EP262 in healthy male participants.
- Conditions
- Healthy Participants
- Being tested
- EP262
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP262Drug
Single dose of [14C]-EP262 administered orally.
| Study group | Role | What they receive |
|---|---|---|
| [14C]-EP262 25 mg | Experimental | Administered orally. Receives: Drug: EP262 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance of [14C]-EP262
Assessed by the total recovery of radioactivity from urine and feces
Measured: Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)
Pharmacokinetics (PK) of EP262 and [14C]
Assessed by the concentration of EP262 in plasma and [14C] in whole blood, plasma, urine, and feces
Measured: Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)
Secondary outcomes (2)
Metabolite profile of EP262
Assessed by the concentration of EP262 metabolites in plasma, urine, and feces
Measured: Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)
Safety and tolerability of [14C]-EP262
Assessed by the incidence of treatment emergent adverse events, clinical laboratory evaluations, vital signs, 12-lead electrocardiogram, and physical examination findings
Measured: Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Oct 2024
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escient Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645704
- Sponsor's protocol ID
- EP-262-104
- Status last verified
- Feb 2025
- First submitted
- 15 Oct 2024
- Last updated
- 24 Feb 2025
- 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 24 Feb 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]-EP262 Following Single-Dose Oral Administration
- ClinicalTrials.gov ID
- NCT06645704
- Acronym / sponsor ID
- EP-262-104
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Escient Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 17 Oct 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.
This study is being conducted to assess the mass balance, pharmacokinetics, and metabolite profiles of a single oral dose of [14C]-EP262 in healthy male participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-EP262 25 mg | Experimental | Drug: EP262Administered orally. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males aged 18 to 55 years
- Body mass index of 18 to 32 kg/m2 and body weight of 55 to 100 kg
- Negative result for HIV, HBV, and HCV at Screening
- Male subjects with female partners of reproductive potential must be surgically sterile or use adequate birth control
- No use of tobacco or nicotine containing products within the past 6 months
Key exclusion criteria (5 listed)
- History or presence of any condition or prior surgery that could pose a significant risk in the opinion of the investigator
- History of malignancy within the past 5 years
- History of any serious allergic reactions or hypersensitivity
- Recent history of incomplete bladder emptying with voiding or awakening more than once at a night to void
- Usual habit of bowel movements of less than 1 or more than 3 bowel movements per day
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 |
|---|---|---|
| EP262Single dose of [14C]-EP262 administered orally. | Drug | [14C]-EP262 25 mg |
Primary outcome
Mass balance of [14C]-EP262
Time frame: Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)
Assessed by the total recovery of radioactivity from urine and feces
Pharmacokinetics (PK) of EP262 and [14C]
Time frame: Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)
Assessed by the concentration of EP262 in plasma and [14C] in whole blood, plasma, urine, and feces
2 secondary outcomes
Metabolite profile of EP262
Time frame: Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)
Safety and tolerability of [14C]-EP262
Time frame: Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)
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 24 Feb 2025.
- 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 EP262 in people with Healthy Participants, run by Escient Pharmaceuticals, 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 5 inclusion and 5 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 24 Feb 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 of [14C]-EP262 (time frame: Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)). The study lists 2 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 24 Feb 2025.