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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Tenofovir exalidex (TXL)

• Registration Number: NCT03279146
• Lead Sponsor: ContraVir Pharmaceuticals, Inc.

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.

Study Timeline

• Study First Submitted: 2017-08-18
• Study Start: 2017-09-06
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-12
• Primary Completion: 2018-06-09
• Study Completion: 2018-06-16
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Regimen B	Tenofovir exalidex (TXL)	New Formulation 1 Tenofovir exalidex (TXL)
Regimen A	Tenofovir exalidex (TXL)	Immediate release tablet Tenofovir exalidex (TXL)
Regimen C	Tenofovir exalidex (TXL)	New formulation 2 Tenofovir exalidex (TXL)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Quotient Clinical; 🇬🇧 Nottingham, United Kingdom