Relative BioavailabilityPhase 1NCT06025318
An Evaluation of the Effect of Food on the PK of a Novel PanCytoVir™ Suspension (100mg/ml), in Healthy, Adult Volunteers
A Phase 1 study testing PanCytoVir™ in people with Relative Bioavailability, run by TrippBio, Inc. at 1 site in India.
Trial summary
This is an open-label, balanced, randomized, two-period, crossover, single dose study to compare the relative bioavailability in normal healthy, adult, human subjects under Fed and Fasting conditions. Subjects will receive a single oral dose of probenecid oral suspension (100 mg/mL) under fed and fasted conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Relative Bioavailability
- What is being tested?
- PanCytoVir™
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIndia
- Study dates
- 1 Sep 2024to 15 Oct 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal healthy adult human subjects.
- Subjects who are willing to participate and give informed consent
- Subjects who are ≥ 18 years of age to ≤ 45 years of age and have a Body Mass Index between ≥18.5 to ≤ 30.0 kg/m2 extremes included, with weight of at least 50 kg.
- Subjects with normal findings as determined by baseline history, physical examination and vital sign examination (blood pressure, pulse rate, respiration rate and body temperature).
- Subjects with clinically acceptable findings as determined by haemogram, biochemistry, urine analysis, 12 lead ECG and chest X-ray.
- Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or grapefruit juice, any alcoholic products, the use of cigarettes and the use of tobacco products for 72.00 hours prior to dosing until after the last blood sample collection in each study period and adherence to food, fluid and posture restrictions.
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- No history of significant alcoholism.
- Subject who have an estimated glomerular filtration rate (eGFR) value is >60ml/min.
- Found negative in Alcohol test.
- Found negative in urine test for drug abuse [Benzodiazepines, Barbiturates, Morphine, Cocaine, Amphetamines and Tetrahydrocannabinol (THC)].
- Non-smokers, ex-smokers and moderate smokers will be included. "Moderate smokers are defined as someone smoking 10 cigarettes or less per day, ex-smokers are someone who completely stopped smoking for at least 3 months."
Who cannot join
- History of allergic responses or hypersensitivity to Probenecid or other related drugs, or any of its ingredients.
- Requiring medication for any ailment having enzyme-modifying activity in the previous 21 days, prior to dosing day.
- Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of study drug
- Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
- History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
- Participation in a clinical drug study or bioequivalence study 90 days prior to period I dosing of the present study.
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- History of malignancy or other serious diseases.
- Blood donation 90 days prior to period I dosing of the present study.
- Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.
- History of problem in swallowing tablets/capsules/ Suspension.
- Any contraindication to blood sampling.
- Female subjects found positive serum (β) Beta- hCG (Human Chorionic Gonadotropin) test.
- Lactating women (currently breast feeding).
- Female subjects not confirming to using birth control measures, from the date of screening until the completion of the study. Abstinence, barrier methods (condom, diaphragm, etc.) are acceptable.
- Use of hormonal contraceptives either oral or implants.
- History of urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Balanced, Randomized, Two-period, Crossover, Single Dose Study to Compare the Bioavailability of PanCytoVir™ Oral Suspension (100mg/ml), in Healthy, Adult, Human Subjects Under Fed and Fasting Conditions
This is an open-label, balanced, randomized, two-period, crossover, single dose study to compare the relative bioavailability in normal healthy, adult, human subjects under Fed and Fasting conditions. Subjects will receive a single oral dose of probenecid oral suspension (100 mg/mL) under fed and fasted conditions.
- Conditions
- Relative Bioavailability
- Being tested
- PanCytoVir™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanCytoVir™Drug
PanCytoVir™ 100 mg/mL oral suspension
| Study group | Role | What they receive |
|---|---|---|
| PanCytoVir™ 1000 mg fasted | Experimental | Single oral dose of PanCytoVir™ 1000 mg (100 mg/mL suspension) following an overnight fast Receives: Drug: PanCytoVir™ |
| PanCytoVir™ 1000 mg fed | Experimental | Single oral dose of PanCytoVir™ 1000 mg (100 mg/mL suspension) following a standard, high-fat, high-calorie breakfast Receives: Drug: PanCytoVir™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess food effect on PanCytoVir™ in healthy, adult, human subjects as assessed by Cmax
The drug concentration in plasma assessed by Cmax
Measured: 7 days
To assess food effect on PanCytoVir™ in healthy, adult, human subjects as assessed by AUC
The drug concentration in plasma assessed by AUC
Measured: 7 days
Secondary outcomes (1)
the Incidence rates of AEs, TEAEs and Serious Adverse Events (SAEs)
Numbers and incidence rates of AEs, TEAEs and Serious Adverse Events (SAEs) will be tabulated using available version of Medical Dictionary for Regulatory Activities (MedDRA) preferred term (PT), system organ class (SOC), severity and relationship. A patient having the same AE will be counted only once in calculating frequency while patient having same AE with different start date then both will be considered for calculating frequency. If AE is with same start date but different criteria (severity, relationship to study medication and outcome), worst case/latest case (whichever applicable) will be considered. Incidence of AEs will be summarized with count (%).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Sep 2024
- Primary completion30 Sep 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relative BioavailabilityStudies 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
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- TrippBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David E Martin, PharmD, Study director, TrippBio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025318
- Sponsor's protocol ID
- VRS-23-001
- Status last verified
- Nov 2024
- First submitted
- 24 Aug 2023
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Plans are currently being developed
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Balanced, Randomized, Two-period, Crossover, Single Dose Study to Compare the Bioavailability of PanCytoVir™ Oral Suspension (100mg/ml), in Healthy, Adult, Human Subjects Under Fed and Fasting Conditions
- ClinicalTrials.gov ID
- NCT06025318
- Acronym / sponsor ID
- VRS-23-001
- Conditions
- Relative Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- TrippBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 6 Sep 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 an open-label, balanced, randomized, two-period, crossover, single dose study to compare the relative bioavailability in normal healthy, adult, human subjects under Fed and Fasting conditions. Subjects will receive a single oral dose of probenecid oral suspension (100 mg/mL) under fed and fasted conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PanCytoVir™ 1000 mg fasted | Experimental | Drug: PanCytoVir™Single oral dose of PanCytoVir™ 1000 mg (100 mg/mL suspension) following an overnight fast |
| PanCytoVir™ 1000 mg fed | Experimental | Drug: PanCytoVir™Single oral dose of PanCytoVir™ 1000 mg (100 mg/mL suspension) following a standard, high-fat, high-calorie breakfast |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Normal healthy adult human subjects.
- Subjects who are willing to participate and give informed consent
- Subjects who are ≥ 18 years of age to ≤ 45 years of age and have a Body Mass Index between ≥18.5 to ≤ 30.0 kg/m2 extremes included, with weight of at least 50 kg.
- Subjects with normal findings as determined by baseline history, physical examination and vital sign examination (blood pressure, pulse rate, respiration rate and body temperature).
- Subjects with clinically acceptable findings as determined by haemogram, biochemistry, urine analysis, 12 lead ECG and chest X-ray.
Key exclusion criteria (16 listed)
- History of allergic responses or hypersensitivity to Probenecid or other related drugs, or any of its ingredients.
- Requiring medication for any ailment having enzyme-modifying activity in the previous 21 days, prior to dosing day.
- Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of study drug
- Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
- History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
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 |
|---|---|---|
| PanCytoVir™PanCytoVir™ 100 mg/mL oral suspension | Drug | PanCytoVir™ 1000 mg fasted, PanCytoVir™ 1000 mg fed |
Primary outcome
To assess food effect on PanCytoVir™ in healthy, adult, human subjects as assessed by Cmax
Time frame: 7 days
The drug concentration in plasma assessed by Cmax
To assess food effect on PanCytoVir™ in healthy, adult, human subjects as assessed by AUC
Time frame: 7 days
The drug concentration in plasma assessed by AUC
1 secondary outcome
the Incidence rates of AEs, TEAEs and Serious Adverse Events (SAEs)
Time frame: 7 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 21 Nov 2024.
- Individual participant dataSharing planned: No. Plans are currently being developed
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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.
David E Martin, PharmD study director
TrippBio, Inc.
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 PanCytoVir™ in people with Relative Bioavailability, run by TrippBio, Inc. at 1 site in India.
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 11 inclusion and 16 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 21 Nov 2024. 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 India. 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?
To assess food effect on PanCytoVir™ in healthy, adult, human subjects as assessed by Cmax (time frame: 7 days). 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 21 Nov 2024.