A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects

ContraVir Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Tenofovir exalidex (TXL)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03279146

CTRV-TXL-103

Details and patient eligibility

About

This is a Phase 1 study to evaluate the PK profile of TXL oral formulations in healthy subjects

Full description

This is a Phase 1 study to evaluate the PK profile of different oral formulations of TXL following single dose administration in healthy subjects.

Enrollment: 29 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age:18-55 Capable of giving written informed consent Capable of completing study requirements

Exclusion criteria

• History or medical condition which could impact patient safety History of drug or alcohol abuse within past 2 years Positive result for HIV, HBV, or HCV Participation in another clinical trial within the past 90 days

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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29 participants in 3 patient groups

Regimen A

Active Comparator group

Description:

Immediate release tablet Tenofovir exalidex (TXL)

Treatment:

Drug: Tenofovir exalidex (TXL)

Regimen B

Experimental group

Description:

New Formulation 1 Tenofovir exalidex (TXL)

Treatment:

Drug: Tenofovir exalidex (TXL)

Regimen C

Experimental group

Description:

New formulation 2 Tenofovir exalidex (TXL)

Treatment:

Drug: Tenofovir exalidex (TXL)