Renal ImpairmentPhase 1NCT03284164
Evaluation of Effect of Renal Impairment on the PK of Tenofovir Exalidex
A Phase 1 study testing Tenofovir Exalidex (TXL) in people with Renal Impairment, run by ContraVir Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is a Phase 1 study to investigate the effects of Renal Impairment on the pharmacokinetics of Tenofovir exalidex Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- Tenofovir Exalidex (TXL)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2017to 20 Feb 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18 years of age and over
- Capable of giving written informed consent
- Capable of completing study requirements
Who cannot join
- Positive result for HIV, HBV, or HCV
- History or medical condition which could impact patient safety
- Current or past abuse of alcohol or drugs
- Participation in another clinical trial within the past 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: An Open-Label Study to Investigate the Effect of Renal Impairment on the Pharmacokinectics of Tenofovir Exalidex
This is a Phase 1 study to investigate the effects of Renal Impairment on the pharmacokinetics of Tenofovir exalidex
Read the detailed description
This is a Phase 1 study to investigate the effects of Renal Impairment (mild, moderate and severe) on the pharmacokinetics of Tenofovir Exalidex
- Conditions
- Renal Impairment
- Being tested
- Tenofovir Exalidex (TXL)
- Medical subject headings
- Renal Insufficiency
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 TFV
Drug: Tenofovir Exalidex (TXL)
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Experimental | Healthy Subjects matched to RI subjects Tenofovir Exalidex (TXL) Receives: Drug: Tenofovir Exalidex (TXL) |
| Severe RI | Experimental | Severe Renal Impairment subjects 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 the pharmacokinetics of TXL in subjects with RI compared to matching healthy volunteers
Measuring Cmax : the peak plasma concentration
Measured: up to six days post dose
Secondary outcomes (2)
Evaluation of the adverse events for TXL in RI subjects
review of Adverse events
Measured: up to six days post dose
Evaluation of safety labs for TXL in RI subjects
review of safety labs
Measured: up to six 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 posted15 Sep 2017
- Study start28 Sep 2017
- Primary completion17 Jan 2018
- Study completion20 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Tenofovir exalidex (TXL)
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT03284164
- Sponsor's protocol ID
- CTRV-TXL-104
- Status last verified
- Feb 2018
- First submitted
- 8 Sep 2017
- Last updated
- 6 Jun 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 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Investigate the Effect of Renal Impairment on the Pharmacokinectics of Tenofovir Exalidex
- ClinicalTrials.gov ID
- NCT03284164
- Acronym / sponsor ID
- CTRV-TXL-104
- Conditions
- Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- ContraVir Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 17 Jan 2018 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 15 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 investigate the effects of Renal Impairment on the pharmacokinetics of Tenofovir exalidex
Detailed description
This is a Phase 1 study to investigate the effects of Renal Impairment (mild, moderate and severe) on the pharmacokinetics of Tenofovir Exalidex
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Tenofovir exalidex (TXL)
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Experimental | Drug: Tenofovir Exalidex (TXL)Healthy Subjects matched to RI subjects Tenofovir Exalidex (TXL) |
| Severe RI | Experimental | Drug: Tenofovir Exalidex (TXL)Severe Renal Impairment subjects Tenofovir Exalidex (TXL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 18 years of age and over
- Capable of giving written informed consent
- Capable of completing study requirements
Key exclusion criteria (4 listed)
- Positive result for HIV, HBV, or HCV
- History or medical condition which could impact patient safety
- Current or past abuse of alcohol or drugs
- Participation in another clinical trial within the past 30 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 TFVDrug: Tenofovir Exalidex (TXL) | Drug | Healthy Subjects, Severe RI |
Primary outcome
Evaluation of the pharmacokinetics of TXL in subjects with RI compared to matching healthy volunteers
Time frame: up to six days post dose
Measuring Cmax : the peak plasma concentration
2 secondary outcomes
Evaluation of the adverse events for TXL in RI subjects
Time frame: up to six days post dose
Evaluation of safety labs for TXL in RI subjects
Time frame: up to six days post dose
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 6 Jun 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 Renal Impairment, run by ContraVir Pharmaceuticals, Inc. at 1 site in United States.
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 3 inclusion and 4 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 6 Jun 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 States. 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 the pharmacokinetics of TXL in subjects with RI compared to matching healthy volunteers (time frame: up to six 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 6 Jun 2018.