Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06025344
Other study ID # VRS-23-002
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date June 2024
Est. completion date October 2024

Study information

Verified date April 2024
Source TrippBio, Inc.
Contact David E. Martin, PharmD
Phone 3015381878
Email davidmartin@trippbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

An open-label, balanced, randomized, two-treatment, two-sequence, two-period, crossover, single dose oral relative bioavailability study of a novel PanCytoVir™ oral suspension (100 mg/mL) versus probenecid 500 mg tablets in normal healthy, adult, human subjects under fasting conditions.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 14
Est. completion date October 2024
Est. primary completion date July 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: 1. Normal healthy adult human subjects. 2. Subjects who are willing to participate and give informed consent 3. 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. 4. Subjects with normal findings as determined by baseline history, physical examination and vital sign examination (blood pressure, pulse rate, respiration rate and body temperature). 5. Subjects with clinically acceptable findings as determined by haemogram, biochemistry, urine analysis, 12 lead ECG and chest X-ray. 6. 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. 7. No history of significant alcoholism. 8. Subject who have estimated glomerular filtration rate (eGFR) value is >60ml/min. 9. Found negative in Alcohol test. 10. Found negative in urine test for drug abuse [Benzodiazepines, Barbiturates, Morphine, Cocaine, Amphetamines and Tetrahydrocannabinol (THC)]. 11. 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." Exclusion Criteria: 1. History of allergic responses or hypersensitivity to Probenecid or other related drugs, or any of its ingredients. 2. Requiring medication for any ailment having enzyme-modifying activity in the previous 21 days, prior to dosing day. 3. Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of study drug. 4. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc. 5. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases. 6. Participation in a clinical drug study or bioequivalence study 90 days prior to period I dosing of the present study. 7. History of malignancy or other serious diseases. 8. Blood donation 90 days prior to period I dosing of the present study. 9. Subjects with positive HIV tests, HBsAg or Hepatitis-C tests. 10. History of problem in swallowing tablets/capsules/ Suspension. 11. Any contraindication to blood sampling. 12. Female subjects found positive serum (ß) Beta- hCG (Human Chorionic Gonadotropin) test. 13. Lactating women (currently breast feeding). 14. 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. 15. Use of hormonal contraceptives either oral or implants. 16. History of urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
PanCytoVir™ 100 mg/mL oral suspension
Single oral dose of 1000 mg (100 mg/mL) under fasted conditions
Probenecid 500 mg
Single oral dose of 1000 mg under fasted conditions

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
TrippBio, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Bioavailability comparison using Cmax 7 days
Primary Bioavailability comparison using AUC 7 days
Secondary 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 (%). 7 days
See also
  Status Clinical Trial Phase
Completed NCT02052349 - Bioavailability of ABT-333 Within the Gastrointestinal Tract in Healthy Subjects Phase 1
Completed NCT01911741 - A Study to Compare Capsule and Tablet Forms of MDV3100 (Enzalutamide) After Administration of a Single Set Dose Under Fasted Conditions in Healthy Male Subjects Phase 1
Active, not recruiting NCT03154840 - Relative Bioavailability Among Different Eutropin Formulations Phase 1
Completed NCT04814472 - Healthy Volunteer Study Comparing Tablet and Oral Solution Formulations Phase 1
Completed NCT03934333 - A Study to Compare the Pharmacokinetics of Budesonide Delivered by PT027 Compared With Pulmicort Flexhaler (ELBRUS) Phase 1
Not yet recruiting NCT06025318 - An Evaluation of the Effect of Food on the PK of a Novel PanCytoVir™ Suspension (100mg/ml), in Healthy, Adult Volunteers Phase 1
Completed NCT04686669 - A Relative Bioavailability Study of FOR-6219 in Capsule and Tablet Formulations Phase 1
Completed NCT03483259 - To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers Phase 1
Completed NCT05296382 - Bioavailability of Tebipenem (SPR994) Crushed Tablet Phase 1