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NCT03279146 Clinical Trial

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

Healthy Volunteers Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03279146
Other study ID # CTRV-TXL-103
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 6, 2017
Est. completion date June 16, 2018

Study information
Verified date July 2018
Source ContraVir Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 29
Est. completion date June 16, 2018
Est. primary completion date June 9, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Tenofovir exalidex (TXL)
Oral formulations

Locations
Country Name City State
United Kingdom Quotient Clinical Nottingham

Sponsors (1)
Lead Sponsor Collaborator
ContraVir Pharmaceuticals, Inc.

Country where clinical trial is conducted

United Kingdom, 

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