A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects
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
1 other identifier
interventional
29
1 country
1
Brief Summary
This is a Phase 1 study to evaluate the PK profile of TXL oral formulations in healthy subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Sep 2017
Typical duration for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2017
CompletedStudy Start
First participant enrolled
September 6, 2017
CompletedFirst Posted
Study publicly available on registry
September 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2018
CompletedAugust 2, 2018
July 1, 2018
9 months
August 18, 2017
July 31, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Regimen A
ACTIVE COMPARATORImmediate release tablet Tenofovir exalidex (TXL)
Regimen B
EXPERIMENTALNew Formulation 1 Tenofovir exalidex (TXL)
Regimen C
EXPERIMENTALNew formulation 2 Tenofovir exalidex (TXL)
Interventions
Oral formulations
Eligibility Criteria
You may qualify if:
- Age:18-55 Capable of giving written informed consent Capable of completing study requirements
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Quotient Clinical
Nottingham, United Kingdom
Study Officials
- STUDY CHAIR
John Sullivan-Bolyai, MD, MPH
ContraVir Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2017
First Posted
September 12, 2017
Study Start
September 6, 2017
Primary Completion
June 9, 2018
Study Completion
June 16, 2018
Last Updated
August 2, 2018
Record last verified: 2018-07