Phase 1 PK study of Tenofovir Exalidex in healthy subjects (QCL118077)
Research type
Research Study
Full title
An Open-Label, Part-Randomised Study Designed to Evaluate the Pharmacokinetic Profile of Tenofovir Exalidex (TXL) Following Single Dose Administration of Oral Formulations in Comparison to a Reference Immediate Release TXL Tablet in Healthy Subjects
IRAS ID
228740
Contact name
John Sullivan-Bólyai
Contact email
Sponsor organisation
ContraVir Pharmaceuticals, Inc.
Eudract number
2017-001904-31
Duration of Study in the UK
0 years, 4 months, 29 days
Research summary
The Sponsor is developing new formulations (formulation means the recipe used to manufacture the test medicine) of the study drug, tenofovir exalidex (TXL), for the potential treatment of Hepatitis B virus (HBV) infection. HBV is a viral infection carried in the blood. HBV is transmitted by contact with an infected person’s blood or body fluids. Patients can develop a chronic form of HBV which attacks the liver and can potentially cause long term damage.
The study consists of up to 2 Parts, Part 1 will investigate how much and how quickly two new TXL formulations are taken up by the body compared to a reference formulation. An optional Part 2 will evaluate an optimised TXL formulation to determine the level of TXL in the blood. TXL is a prodrug, which is an inactivate form of the drug and once absorbed in the body it’s converted into the active drug, tenofovir. The new TXL formulations will also be assessed for their level of breakdown to determine their safety and tolerability.
Both Part 1 and 2 will involve up to 15 healthy subjects. In part 1, subjects will attend the clinical unit on 3 occasions (regimen A-C). In regimen A and C subjects will swallow a 50mg TXL tablet. In regimen B, subjects will swallow a 50mg TXL liquid medicine. Subjects will be dosed on day 1 following a fasting period. For Part 2, subjects will attend the clinic on up to 3 occasions and receive one dose of an optimised TXL formulation. For both parts, subjects will remain for safety and absorption assessments until 72 hours post-dose. There will be a minimum of 7 days between each product administration. A follow up phone call will take place 5 to 7 days after the final dose to ensure the continued well-being of the subjects.
REC name
London - Brent Research Ethics Committee
REC reference
17/LO/1272
Date of REC Opinion
4 Sep 2017
REC opinion
Further Information Favourable Opinion