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

ContraVir Pharmaceuticals, Inc.29 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

Tenofovir exalidex (TXL)DRUG

Oral formulations

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Quotient Clinical

Nottingham, United Kingdom

Outcomes

Primary Outcomes

Evaluation of pharmacokinetics of single dose oral formulations of TXL in fasted state

Measuring Cmax, the peak plasma concentration

Time frame: up to four days post dose

Data from ClinicalTrials.gov

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