HealthyPhase 1NCT04634812
Mass Balance Study of KBP-5074 in Healthy Male Subjects
A Phase 1 study testing KBP-5074 in people with Healthy, run by KBP Biosciences at 1 site in United States.
Trial summary
This is a Phase 1, open-label, nonrandomized, single-dose mass balance and metabolite identification study in healthy male subjects. 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
- What is being tested?
- KBP-5074
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2020to 23 Dec 2020
- 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, of any race, between 18 and 55 years of age, inclusive, at screening.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening.
- In good health, determined by no clinically significant findings from medical history, physical examination (assessed only at check-in), 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in as assessed by the investigator (or designee).
- History of a minimum of 1 bowel movement per day.
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, psychiatric, or other disorder, as determined by the investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed; cholecystectomy will not be allowed).
- Positive urine drug screen, including cotinine, at screening; positive alcohol test result or positive urine drug screen, including cotinine, at check-in.
- Use of any drugs or substances known to be strong or moderate inhibitors or inducers of cytochrome P450 (CYP)3A4 or P-glycoprotein substrates within 30 days prior to study drug administration. Medications will be reviewed by the medical monitor to determine acceptability for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit Inc.
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1, Open-label, Study of the Absorption, Metabolism, and Excretion of [14C]-KBP-5074 Following a Single Oral Dose in Healthy Male Subjects
This is a Phase 1, open-label, nonrandomized, single-dose mass balance and metabolite identification study in healthy male subjects.
- Conditions
- Healthy
- Being tested
- KBP-5074
- Keywords
- Healthy Male Subjects, KBP-5074
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KBP-5074Drug
a single oral dose of [14C]-KBP-5074
| Study group | Role | What they receive |
|---|---|---|
| [14C]-KBP-5074 | Experimental | Not described Receives: Drug: KBP-5074 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass Balance of KBP-5074
Percentage of total radioactivity recovered in urine and feces following a single dose [14C]-KBP-5074
Measured: up to 240 hours postdose
Pharmacokinetic Parameter: Area under the concentration-time curve from time 0 to infinity (AUC0-∞)
Area under the concentration-time curve from time 0 to infinity (AUC0-∞) - Plasma
Measured: up to 216 hours postdose
Pharmacokinetic Parameter: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast)
Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast) - Plasma
Measured: up to 216 hours postdose
Pharmacokinetic Parameter: Time of the maximum observed concentration (Cmax)
Time of the maximum observed concentration (Cmax) - Plasma
Measured: up to 216 hours postdose
Secondary outcomes (1)
Metabolite radioprofiling and identification in plasma, urine and feces
Select plasma, urine, and fecal samples will be processed and subject to metabolite analysis by LC/MS \& LC/MS/MS using high-resolution mass spectrometry.
Measured: up to 240 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start3 Dec 2020
- Primary completion23 Dec 2020
- Study completion23 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- KBP Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
- Investigators
- James McCabe, Study director, KBP Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634812
- Sponsor's protocol ID
- KBP5074-1-007
- Status last verified
- Dec 2025
- First submitted
- 12 Nov 2020
- Last updated
- 16 Dec 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 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Study of the Absorption, Metabolism, and Excretion of [14C]-KBP-5074 Following a Single Oral Dose in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04634812
- Acronym / sponsor ID
- KBP5074-1-007
- Conditions
- Healthy
- Keywords
- Healthy Male Subjects, KBP-5074
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- KBP BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 23 Dec 2020 (actual)
- Study completion
- 23 Dec 2020 (actual)
- First posted
- 18 Nov 2020 (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 is a Phase 1, open-label, nonrandomized, single-dose mass balance and metabolite identification study in healthy male subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-KBP-5074 | Experimental | Drug: KBP-5074 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males, of any race, between 18 and 55 years of age, inclusive, at screening.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening.
- In good health, determined by no clinically significant findings from medical history, physical examination (assessed only at check-in), 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in as assessed by the investigator (or designee).
- History of a minimum of 1 bowel movement per day.
Key exclusion criteria (4 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, psychiatric, or other disorder, as determined by the investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed; cholecystectomy will not be allowed).
- Positive urine drug screen, including cotinine, at screening; positive alcohol test result or positive urine drug screen, including cotinine, at check-in.
- Use of any drugs or substances known to be strong or moderate inhibitors or inducers of cytochrome P450 (CYP)3A4 or P-glycoprotein substrates within 30 days prior to study drug administration. Medications will be reviewed by the medical monitor to determine acceptability for the study.
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 |
|---|---|---|
| KBP-5074a single oral dose of [14C]-KBP-5074 | Drug | [14C]-KBP-5074 |
Primary outcome
Mass Balance of KBP-5074
Time frame: up to 240 hours postdose
Percentage of total radioactivity recovered in urine and feces following a single dose [14C]-KBP-5074
Pharmacokinetic Parameter: Area under the concentration-time curve from time 0 to infinity (AUC0-∞)
Time frame: up to 216 hours postdose
Area under the concentration-time curve from time 0 to infinity (AUC0-∞) - Plasma
Pharmacokinetic Parameter: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast)
Time frame: up to 216 hours postdose
Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast) - Plasma
Pharmacokinetic Parameter: Time of the maximum observed concentration (Cmax)
Time frame: up to 216 hours postdose
Time of the maximum observed concentration (Cmax) - Plasma
1 secondary outcome
Metabolite radioprofiling and identification in plasma, urine and feces
Time frame: up to 240 hours postdose
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 Dec 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.
James McCabe study director
KBP Biosciences
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 KBP-5074 in people with Healthy, run by KBP Biosciences 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 4 inclusion and 4 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 Dec 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 KBP-5074 (time frame: up to 240 hours postdose). The study lists 4 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 Dec 2025.