CompletedNCT03279146Updated Aug 2, 2018

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

A Phase 1 interventional study of Tenofovir exalidex (TXL) in Healthy Volunteers, sponsored by ContraVir Pharmaceuticals, Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-02.

Sponsored by ContraVir Pharmaceuticals, Inc. · Phase 1, Interventional, and Other

Phase: Phase 1
Study type: Interventional
Enrollment: 29
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

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

Read the 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.

Conditions studied

Healthy Volunteers

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Age:18-55 Capable of giving written informed consent Capable of completing study requirements

Exclusion criteria

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

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 29 participants (actual)

Study arms

Active comparator
Regimen A
Immediate release tablet Tenofovir exalidex (TXL)
Drug: Tenofovir exalidex (TXL)
Experimental
Regimen B
New Formulation 1 Tenofovir exalidex (TXL)
Drug: Tenofovir exalidex (TXL)
Experimental
Regimen C
New formulation 2 Tenofovir exalidex (TXL)
Drug: Tenofovir exalidex (TXL)

Interventions

DrugTenofovir exalidex (TXL)
Oral formulations
Also known as: Lipid conjugate YTFV

What researchers measure

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

Study locations

1 site

Quotient Clinical
Nottingham, United Kingdom

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03279146
Lead sponsor: ContraVir Pharmaceuticals, Inc.
Responsible party: Sponsor
First posted: Sep 12, 2017
Start date: Sep 6, 2017
Primary completion: Jun 9, 2018
Completion: Jun 16, 2018
Last update: Aug 2, 2018

Study contacts

John Sullivan-Bolyai, MD, MPH

study chair · ContraVir Pharmaceuticals

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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ContraVir Pharmaceuticals, Inc.

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