Healthy VolunteersPhase 1NCT03279146
A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects
A Phase 1 study testing Tenofovir exalidex (TXL) in people with Healthy Volunteers, run by ContraVir Pharmaceuticals, Inc. at 1 site in United Kingdom.
Trial summary
This is a Phase 1 study to evaluate the PK profile of TXL oral formulations in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Tenofovir exalidex (TXL)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Sep 2017to 16 Jun 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age:18-55 Capable of giving written informed consent Capable of completing study requirements
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Healthy Volunteers
- Being tested
- Tenofovir exalidex (TXL)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir exalidex (TXL)Drug
Also called Lipid conjugate YTFV
Oral formulations
| Study group | Role | What they receive |
|---|---|---|
| Regimen A | Active comparator | Immediate release tablet Tenofovir exalidex (TXL) Receives: Drug: Tenofovir exalidex (TXL) |
| Regimen B | Experimental | New Formulation 1 Tenofovir exalidex (TXL) Receives: Drug: Tenofovir exalidex (TXL) |
| Regimen C | Experimental | New formulation 2 Tenofovir exalidex (TXL) Receives: Drug: Tenofovir exalidex (TXL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pharmacokinetics of single dose oral formulations of TXL in fasted state
Measuring Cmax, the peak plasma concentration
Measured: up to four days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start6 Sep 2017
- Primary completion9 Jun 2018
- Study completion16 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Drug: Tenofovir Exalidex (TXL) oral formulations Other names: Lipid conjugateTFV
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- ContraVir Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Sullivan-Bolyai, MD, MPH, Study chair, ContraVir Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279146
- Sponsor's protocol ID
- CTRV-TXL-103
- Status last verified
- Jul 2018
- First submitted
- 18 Aug 2017
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03279146
- Acronym / sponsor ID
- CTRV-TXL-103
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- ContraVir Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 9 Jun 2018 (actual)
- Study completion
- 16 Jun 2018 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Drug: Tenofovir Exalidex (TXL) oral formulations Other names: Lipid conjugateTFV
| Arm | Type | Receives |
|---|---|---|
| Regimen A | Active comparator | Drug: Tenofovir exalidex (TXL)Immediate release tablet Tenofovir exalidex (TXL) |
| Regimen B | Experimental | Drug: Tenofovir exalidex (TXL)New Formulation 1 Tenofovir exalidex (TXL) |
| Regimen C | Experimental | Drug: Tenofovir exalidex (TXL)New formulation 2 Tenofovir exalidex (TXL) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age:18-55 Capable of giving written informed consent Capable of completing study requirements
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir exalidex (TXL)Also: Lipid conjugate YTFVOral formulations | Drug | Regimen A, Regimen B, Regimen C |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Sullivan-Bolyai, MD, MPH study chair
ContraVir Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tenofovir exalidex (TXL) in people with Healthy Volunteers, run by ContraVir Pharmaceuticals, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of pharmacokinetics of single dose oral formulations of TXL in fasted state (time frame: up to four days post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.