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

Open-Label, Part-Randomized Study Designed to Evaluate the PK Profile of Tenofovir Exalidex (TXL) Following Single Dose of Oral Formulations in Comparison to a Reference IR TXL Tablet in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03279146

Enrollment

Registered

2017-09-12

Start date

2017-09-06

Completion date

2018-06-16

Last updated

2018-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

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

Detailed 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.

Interventions

DRUGTenofovir exalidex (TXL)

Oral formulations

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Intervention model description

Drug: Tenofovir Exalidex (TXL) oral formulations Other names: Lipid conjugateTFV

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of pharmacokinetics of single dose oral formulations of TXL in fasted state	up to four days post dose	Measuring Cmax, the peak plasma concentration

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026