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

NCT ID: NCT03279146

Last Updated: 2018-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-06

Study Completion Date

2018-06-16

Brief Summary

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

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Detailed Description

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

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

OTHER

Blinding Strategy

NONE

Study Groups

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Regimen A

Immediate release tablet Tenofovir exalidex (TXL)

Group Type ACTIVE_COMPARATOR

Tenofovir exalidex (TXL)

Intervention Type DRUG

Oral formulations

Regimen B

New Formulation 1 Tenofovir exalidex (TXL)

Group Type EXPERIMENTAL

Tenofovir exalidex (TXL)

Intervention Type DRUG

Oral formulations

Regimen C

New formulation 2 Tenofovir exalidex (TXL)

Group Type EXPERIMENTAL

Tenofovir exalidex (TXL)

Intervention Type DRUG

Oral formulations

Interventions

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Tenofovir exalidex (TXL)

Oral formulations

Intervention Type DRUG

Other Intervention Names

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Lipid conjugate YTFV

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ContraVir Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Sullivan-Bolyai, MD, MPH

Role: STUDY_CHAIR

ContraVir Pharmaceuticals

Locations

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Quotient Clinical

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CTRV-TXL-103

Identifier Type: -

Identifier Source: org_study_id

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