Absorption, Metabolism and Excretion in Healthy VolunteersPhase 1NCT05238337
A Phase 1 Study of the Absorption, Metabolism, and Excretion of [14C] PBI-200
A Phase 1 study testing [14C]-PBI-200 in people with Absorption, Metabolism and Excretion in Healthy Volunteers, run by Pyramid Biosciences at 1 site in United States.
Trial summary
This is a Phase 1, open-label non-randomized, single dose study in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Absorption, Metabolism and Excretion in Healthy Volunteers
- What is being tested?
- [14C]-PBI-200
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2022to 24 Mar 2022
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males, of any race, 18 to 65 years of age as of the dosing day.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- Non-smoking/non-vaping, healthy, with no history of clinically relevant medical illness.
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Labcorp 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] PBI-200 Following a Single Oral Dose in Healthy Male Subjects
This is a Phase 1, open-label non-randomized, single dose study in healthy male subjects.
Read the detailed description
This is a Phase 1, open-label nonrandomized, single dose study in healthy male subjects to determine the absorption, metabolism, and excretion (AME) of [14C]-PBI-200
- Being tested
- [14C]-PBI-200
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-PBI-200Drug
[14C]-radio-labeled-PBI-200
| Study group | Role | What they receive |
|---|---|---|
| [14C]-PBI-200 Treated | Experimental | [14C]-labeled PBI-200 will be administered as a single dose Receives: Drug: [14C]-PBI-200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Radioactivity in Urine and Feces
Measured: 28 days
Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to infinity [AUC(0-inf)]
Measured: 28 days
Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to the time of the last quantifiable concentration [AUC(0-tlast)
Measured: 28 days
Maximum Observed Concentration [C(max)]
Measured: 28 days
Time to Maximum Concentration [T(max)]
Measured: 28 days
Apparent Terminal Elimination Half-life [t(1/2)]
Measured: 28 days
Total Radioactivity in Plasma and Whole Blood
Measured: 28 days
Ratio for AUC(0-inf) Blood / Plasma
Measured: 28 days
Ratio for AUC(0-inf) Plasma PBI-200 / Total Radioactivity
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start24 Feb 2022
- Primary completion24 Mar 2022
- Study completion24 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Absorption, Metabolism and Excretion in Healthy VolunteersStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pyramid Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Pyramid Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238337
- Sponsor's protocol ID
- PBI-200-104
- Status last verified
- Aug 2022
- First submitted
- 3 Feb 2022
- Last updated
- 30 Aug 2022
- 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 30 Aug 2022. 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] PBI-200 Following a Single Oral Dose in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05238337
- Acronym / sponsor ID
- PBI-200-104
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Pyramid BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 14 Feb 2022 (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 non-randomized, single dose study in healthy male subjects.
Detailed description
This is a Phase 1, open-label nonrandomized, single dose study in healthy male subjects to determine the absorption, metabolism, and excretion (AME) of [14C]-PBI-200
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-PBI-200 Treated | Experimental | Drug: [14C]-PBI-200[14C]-labeled PBI-200 will be administered as a single dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males, of any race, 18 to 65 years of age as of the dosing day.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- Non-smoking/non-vaping, healthy, with no history of clinically relevant medical illness.
Key exclusion criteria (3 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.
- 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).
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]-PBI-200[14C]-radio-labeled-PBI-200 | Drug | [14C]-PBI-200 Treated |
Primary outcome
Total Radioactivity in Urine and Feces
Time frame: 28 days
Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to infinity [AUC(0-inf)]
Time frame: 28 days
Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to the time of the last quantifiable concentration [AUC(0-tlast)
Time frame: 28 days
Maximum Observed Concentration [C(max)]
Time frame: 28 days
Time to Maximum Concentration [T(max)]
Time frame: 28 days
Apparent Terminal Elimination Half-life [t(1/2)]
Time frame: 28 days
Total Radioactivity in Plasma and Whole Blood
Time frame: 28 days
Ratio for AUC(0-inf) Blood / Plasma
Time frame: 28 days
Ratio for AUC(0-inf) Plasma PBI-200 / Total Radioactivity
Time frame: 28 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 30 Aug 2022.
- 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.
Chief Medical Officer study director
Pyramid 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 [14C]-PBI-200 in people with Absorption, Metabolism and Excretion in Healthy Volunteers, run by Pyramid 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 3 inclusion and 3 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 30 Aug 2022. 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?
Total Radioactivity in Urine and Feces (time frame: 28 days). The study lists 9 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 30 Aug 2022.