None listed
Conditions
Interventions
Intervention1: Tenofovir Pivafen Fumarate Tablets (TPF): Dosing - Single dose,Route of
Administration - Oral
Dose, Total duration :All subjects will be required to fast overnight for at least 10 hours
Sponsors
Cipla Ltd.,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Non-smoking, normal, healthy adult male human volunteers between 18 to 45 years of age (both inclusive).2) Having a Body Mass Index (BMI) between 18.5 and 30.0 (both inclusive), calculated as weight in kg / height in m2 and body weight greater than or equal to 50 kg.3) Not having any significant disease in medical history or clinically significant abnormal findings during screening, physical examination, laboratory evaluations, 12- lead ECG and X-ray chest (P/A view) recordings.4) Subject is healthy as determined by past medical history, screening physical examination and ECG. Screening ECG (two repeats will be allowed) indicating QTcF less than 450 msec or QRS less than 120 msec5) Able to understand and comply with the study procedures, in the opinion of the investigator.6) Volunteer should be literate 7) Subjects with Heart rate equal or more than 50 /min 8) Able to give voluntary written informed consent for participation in the study.9) Subjects who agree to practice adequate contraception and agree to refrain from donating sperm during the study. 10) No fever or history of fever in the last 72 hours prior to check-in
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to tenofovir pivafen fumarate or any excipients or any related drug or any substance.2. History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.3. History or presence of structural heart disease, e.g., ischemic cardiomyopathy, left ventricular hypertrophy.4. Genetic defects of cardiac ion channels, including subtle genetic polymorphisms based on ECG 5. Alanine aminotransferase (ALT) greater than or equal to 1.5 times upper limit of normal (ULN), Aspartate aminotransferase (AST) greater than or equal to 1.5 times ULN; Alkaline phosphatase greater than or equal to 1.5 times ULN; Bilirubin greater than 1.5 Ã? ULN (isolated bilirubin greater than 1.5 Ã? ULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%).6. Subjects with clinically significant ECG abnormalities.7. Ingestion of a medication [prescribed & over the counter (OTC) medication and herbal remedies] at any time in 14 days prior to check-in and any vaccine (including COVID-19 vaccine) from 14 days prior to check-in. In any such case subject selection will be at the discretion of the Principal Investigator.8. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.9. A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc.) or consumption of alcohol or alcoholic products within 48 hours prior to check-in.10. Consumption of xanthine containing food or beverages (like tea, coffee, chocolates or cola drinks), tobacco, tobacco containing products (Gutkha, Pan/Pan masala or any other) for 24 hours prior to check-in 11. Smokers or who have smoked within last 06 months prior to start of the study.12. Consumption of grapefruits or grapefruit products within a period of 72 hours prior to check-in.13. The presence of clinically significant abnormallaboratory values during screening.14. Difficulty in swallowing solids dosage forms like tablets or capsules15. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans. 16. History or presence of seizures or psychiatric disorders.17. A history of difficulty in donating blood.18. Donation of blood (1 unit or 350 mL) within a period of 04 months prior to the dose of study medication.19. Receipt of an investigational medicinal product or participation in a drug research study within a period of 04 months prior to the study medication.20. A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.21. A positive test result for HIV antibody (1 &/or 2).22. An unusual diet, for whatever reason (e.g. fasting, high potassium or low-sodium), for four weeks prior to check-in. In any such case subject selection will be at the discretion of the Principal Investigator.23. subjects with less than 10 ng/ml Vitamin D 24. Presenting any suggestive clinical evidence of active or latent tuberculosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the dose-related safety and tolerability of Tenofovir Pivafen Fumarate after single ascending oral doses in healthy adult male subjects. Timepoint: Pre-dose for Urine analysis (-12â??0) and at 0â??6, 6â??12, 12â??24, 24â??30, 30â??36, 36â??48, and 48â??72 hours post-dose For blood sampling -pre-dose (0.000 hour) and at 0.250, 0.500, 1.000, 2.000, 3.000, 4.000, 6.000, 8.000, 12.000, 24.000, 36.000, 48.000, 72.000, 96.000, 120.000, 144.000 and 168.000 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetics (PK) of TPF & its metabolites (Tenphenol & Tenofovir) after single ascending oral doses in healthy adult male subjects â?¢ To determine PK proportionality, if any, with ascending single doses of TPF . To determine the intracellular concentration of TPF & its metabolites in harvested peripheral blood mononuclear cells (PBMCs)Timepoint: Pre-dose for urine analysis:(-12â??0) & at 0â??6, 6â??12, 12â??24, 24â??30, 30â??36, 36â??48, & 48â??72 hours post-dose For Blood analysis : pre-dose (0.000 hour) & at 0.250, 0.500, 1.000, 2.000, 3.000, 4.000, 6.000, 8.000, 12.000, 24.000, 36.000, 48.000, 72.000, 96.000, 120.000, 144.000 & 168.000 | — |
Countries
India
Contacts
Public ContactDr Hemant Joshi
Lambda Therapeutic Research Ltd
Outcome results
None listed