Formulation BridgingPhase 1NCT05690932
A Formulation Bridging and Food Effect Study of PBI-200 in Healthy Volunteers
A Phase 1 study testing PBI-200 Tablet, PBI-200 Capsule and PBI-200 Suspension in people with Formulation Bridging and Food Effect, run by Pyramid Biosciences at 1 site in United States.
Trial summary
This is a single-dose, two-part, crossover formulation bridging and food effect study to assess the effect of formulation and food on the absorption and bioavailability of PBI-200 in normal, healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Formulation Bridging, Food Effect
- What is being tested?
- PBI-200 Tablet, PBI-200 Capsule and PBI-200 Suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2022to 23 May 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or non-pregnant, non-lactating female between 18 and 55 years of age (inclusive).
- Body Mass Index (BMI) 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
- History or presence of clinically significant cardiovascular, pulmonary, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease which, in the opinion of the Investigator, would jeopardize the safety of the volunteer or impact the validity of the study results.
- History of gastrointestinal/hepatobiliary or other surgery that may affect PK profiles (i.e., hepatectomy, gastric, bypass, or digestive organ resection).
- Intolerance to repeated venipuncture.
- Smoking or use of tobacco products (including vaping) within 3 months prior to the first study drug administration.
- Have a positive drug/alcohol screen, or history or presence of alcoholism or drug abuse within 6 months of first study drug administration.
- Volunteers with a corrected QT using Fridericia's formula (QTcF) prolongation over 450 milliseconds at Screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bio-Kinetic Clinical Applications
Springfield, Missouri, 65802
About this study
Official title: A Single-Dose, Open-Label, Two-Part, Randomized, Crossover Formulation Bridging and Food Effect Study to Assess the Effect of Formulation and Food on the Absorption and Bioavailability of PBI-200 in Normal Healthy Volunteers
This is a single-dose, two-part, crossover formulation bridging and food effect study to assess the effect of formulation and food on the absorption and bioavailability of PBI-200 in normal, healthy volunteers.
Read the detailed description
This is a single-dose, two-part crossover formulation bridging (Part A) and tablet food effect (Part B) study in normal, healthy volunteers. Part A will be conducted to evaluate the pharmacokinetics (PK) and relative bioavailability of 3 formulations of PBI-200; each volunteer will serve as their own control. In Part B, PBI-200 tablets will be dosed under fasting and fed (low-fat and high-fat meals) conditions to evaluate the effect of food on the PK of PBI-200.
- Conditions
- Formulation Bridging, Food Effect
- Being tested
- PBI-200 Tablet, PBI-200 Capsule, PBI-200 Suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBI-200 TabletDrug
Single dose of PBI-200 tablet
PBI-200 CapsuleDrug
Single dose of PBI-200 capsule
PBI-200 SuspensionDrug
Single dose of PBI-200 suspension
| Study group | Role | What they receive |
|---|---|---|
| Capsule | Experimental | Study drug will be administered with water after an overnight fast. Receives: Drug: PBI-200 Capsule |
| Tablet | Experimental | Study drug will be administered with water after an overnight fast. Receives: Drug: PBI-200 Tablet |
| Suspension | Experimental | Study drug will be administered with water after an overnight fast. Receives: Drug: PBI-200 Suspension |
| Fasted | Experimental | Study drug will be administered with water after an overnight fast. Receives: Drug: PBI-200 Tablet |
| Low-fat Meal | Experimental | Study drug will be administered with water after an overnight fast, after which time a standard low-fat breakfast will be given. Receives: Drug: PBI-200 Tablet |
| High-fat Meal | Experimental | Study drug will be administered with water after an overnight fast, after which time a standard high-fat breakfast will be given. Receives: Drug: PBI-200 Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration [C(max)] of PBI-200
Maximum (peak) plasma drug concentration
Measured: 8 days
Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to the time of th last measurable concentration [AUC(0-t)]
AUC, calculated using linear up / log down trapezoidal method from time zero to time t, where t is the time of the last measurable concentration.
Measured: 8 days
AUC of PBI-200 from time zero to infinity [AUC(0-inf)]
AUC from time zero to infinity, AUC(0-inf) = AUC(0-t) + Ct/kel, where kel is the terminal rate constant and Ct is the last measurable concentration.
Measured: 8 days
Secondary outcomes (3)
Time to Maximum Concentration [T(max)] of PBI-200
T(max) will be determined from the observed plasma concentration data
Measured: 8 days
Terminal elimination half-life [T(1/2)]
Apparent terminal elimination half-life, calculated as ln(2)/kel
Measured: 8 days
Incidence, frequency and severity of adverse events (AEs)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start24 Feb 2022
- Primary completion23 May 2022
- Study completion23 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Formulation BridgingStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Single-dose, open-label, randomized, three-way crossover design
- Masking
- None (open label)
- Enrolment
- 33 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
- NCT05690932
- Sponsor's protocol ID
- PBI-200-105
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2023
- Last updated
- 1 Feb 2023
- 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 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label, Two-Part, Randomized, Crossover Formulation Bridging and Food Effect Study to Assess the Effect of Formulation and Food on the Absorption and Bioavailability of PBI-200 in Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05690932
- Acronym / sponsor ID
- PBI-200-105
- Conditions
- Formulation Bridging, Food Effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Pyramid BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 23 May 2022 (actual)
- First posted
- 19 Jan 2023 (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 single-dose, two-part, crossover formulation bridging and food effect study to assess the effect of formulation and food on the absorption and bioavailability of PBI-200 in normal, healthy volunteers.
Detailed description
This is a single-dose, two-part crossover formulation bridging (Part A) and tablet food effect (Part B) study in normal, healthy volunteers. Part A will be conducted to evaluate the pharmacokinetics (PK) and relative bioavailability of 3 formulations of PBI-200; each volunteer will serve as their own control. In Part B, PBI-200 tablets will be dosed under fasting and fed (low-fat and high-fat meals) conditions to evaluate the effect of food on the PK of PBI-200.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Single-dose, open-label, randomized, three-way crossover design
| Arm | Type | Receives |
|---|---|---|
| Capsule | Experimental | Drug: PBI-200 CapsuleStudy drug will be administered with water after an overnight fast. |
| Tablet | Experimental | Drug: PBI-200 TabletStudy drug will be administered with water after an overnight fast. |
| Suspension | Experimental | Drug: PBI-200 SuspensionStudy drug will be administered with water after an overnight fast. |
| Fasted | Experimental | Drug: PBI-200 TabletStudy drug will be administered with water after an overnight fast. |
| Low-fat Meal | Experimental | Drug: PBI-200 TabletStudy drug will be administered with water after an overnight fast, after which time a standard low-fat breakfast will be given. |
| High-fat Meal | Experimental | Drug: PBI-200 TabletStudy drug will be administered with water after an overnight fast, after which time a standard high-fat breakfast will be given. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or non-pregnant, non-lactating female between 18 and 55 years of age (inclusive).
- Body Mass Index (BMI) 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 (6 listed)
- History or presence of clinically significant cardiovascular, pulmonary, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease which, in the opinion of the Investigator, would jeopardize the safety of the volunteer or impact the validity of the study results.
- History of gastrointestinal/hepatobiliary or other surgery that may affect PK profiles (i.e., hepatectomy, gastric, bypass, or digestive organ resection).
- Intolerance to repeated venipuncture.
- Smoking or use of tobacco products (including vaping) within 3 months prior to the first study drug administration.
- Have a positive drug/alcohol screen, or history or presence of alcoholism or drug abuse within 6 months of first study drug administration.
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 |
|---|---|---|
| PBI-200 TabletSingle dose of PBI-200 tablet | Drug | Fasted, High-fat Meal, Low-fat Meal, Tablet |
| PBI-200 CapsuleSingle dose of PBI-200 capsule | Drug | Capsule |
| PBI-200 SuspensionSingle dose of PBI-200 suspension | Drug | Suspension |
Primary outcome
Maximum Plasma Concentration [C(max)] of PBI-200
Time frame: 8 days
Maximum (peak) plasma drug concentration
Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to the time of th last measurable concentration [AUC(0-t)]
Time frame: 8 days
AUC, calculated using linear up / log down trapezoidal method from time zero to time t, where t is the time of the last measurable concentration.
AUC of PBI-200 from time zero to infinity [AUC(0-inf)]
Time frame: 8 days
AUC from time zero to infinity, AUC(0-inf) = AUC(0-t) + Ct/kel, where kel is the terminal rate constant and Ct is the last measurable concentration.
3 secondary outcomes
Time to Maximum Concentration [T(max)] of PBI-200
Time frame: 8 days
Terminal elimination half-life [T(1/2)]
Time frame: 8 days
Incidence, frequency and severity of adverse events (AEs)
Time frame: 14 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 1 Feb 2023.
- Individual participant dataSharing planned: No
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 PBI-200 Tablet, PBI-200 Capsule and PBI-200 Suspension in people with Formulation Bridging and Food Effect, 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 6 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 1 Feb 2023. 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?
Maximum Plasma Concentration [C(max)] of PBI-200 (time frame: 8 days). The study lists 3 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 1 Feb 2023.