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

July 31, 2018 updated by: ContraVir Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Regimen A
Immediate release tablet Tenofovir exalidex (TXL)
Drug: Tenofovir exalidex (TXL)
Oral formulations
Other Names:
  • Lipid conjugate YTFV
Experimental: Regimen B
New Formulation 1 Tenofovir exalidex (TXL)
Drug: Tenofovir exalidex (TXL)
Oral formulations
Other Names:
  • Lipid conjugate YTFV
Experimental: Regimen C
New formulation 2 Tenofovir exalidex (TXL)
Drug: Tenofovir exalidex (TXL)
Oral formulations
Other Names:
  • Lipid conjugate YTFV

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ContraVir Pharmaceuticals, Inc.

Investigators

  • Study Chair: John Sullivan-Bolyai, MD, MPH, ContraVir Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2017

Primary Completion (Actual)

June 9, 2018

Study Completion (Actual)

June 16, 2018

Study Registration Dates

First Submitted

August 18, 2017

First Submitted That Met QC Criteria

September 8, 2017

First Posted (Actual)

September 12, 2017

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTRV-TXL-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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