Prosthetic Joint InfectionPhase 1NCT04294862
Tissue Distribution, Pharmacokinetics, Safety, and Tolerability After a Single Dose of TNP-2092 in Participants Undergoing Primary Total Hip or Knee Arthroplasty
A Phase 1 study testing TNP-2092 in people with Prosthetic Joint Infection, run by TenNor Therapeutics Limited at 1 site in United States.
Trial summary
This study will investigate TNP-2092 distribution into joint tissues in participants undergoing a total hip arthroplasty (THA) or a total knee arthroplasty (TKA). Tissue distribution is the primary objective, and plasma pharmacokinetics (PK), safety, and tolerability are secondary objectives. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic Joint Infection
- What is being tested?
- TNP-2092
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 29 Jun 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants are eligible to be included in the study only if all inclusion criteria are met:
- Male or females, 18 years of age or older
- Participants who require primary THA or TKA
- Body mass index (BMI) >=18 kg/m2 but <=40 kg/m2
- Capable of giving signed informed consent
Who cannot join
- Participants are excluded from the study if any of the following exclusion criteria are met:
- History or hypersensitivity or intolerability to any of the following drugs: any member of fluoroquinolones, rifamycin, cefazolin or TNP-2092
- History of known methicillin-resistant Staphylococcus aureus (MRSA) infections
- Presence of any surgical or medical condition that in the opinion of the principal investigator and the medical monitor that could impact the interpretation of the results of the study;
- Evidence of significant hepatic, hematologic or immunologic disease;
- History or evidence of severe renal disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: An Open-Label Study to Evaluate Tissue Distribution, Plasma Pharmacokinetics, Safety, and Tolerability After a Single Intravenous Dose of TNP-2092 in Adult Participants Undergoing Primary Total Hip or Knee Arthroplasty
This study will investigate TNP-2092 distribution into joint tissues in participants undergoing a total hip arthroplasty (THA) or a total knee arthroplasty (TKA). Tissue distribution is the primary objective, and plasma pharmacokinetics (PK), safety, and tolerability are secondary objectives.
Read the detailed description
This is a Phase 1, open-label study to evaluate the tissue distribution, plasma PK, safety, and tolerability after a single 300 mg intravenous (IV) dose of TNP-2092 administered before induction of anesthesia in adult participants undergoing THA or TKA. Sixteen patients who are scheduled to undergo primary THA or TKA will be enrolled.
The enrolled participants who meet the inclusion/exclusion criteria will receive the study intervention (a single 300 mg IV dose of TNP-2092) 2 hours before induction of anesthesia on Day 1. Tissue samples from bone and synovial fluid will be collected during surgery and analyzed for TNP-2092 and cefazolin concentrations. Plasma samples will be collected on Day 1 and Day 2 for PK analysis. Safety and tolerability information will be collected on Day 1 and Day 2 at the clinical center, on Day 7 by phone, and on Day 14 at a final follow-up visit.
- Conditions
- Prosthetic Joint Infection
- Being tested
- TNP-2092
- Keywords
- TNP-2092, tissue distribution, THA, TKA, safety, PK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNP-2092Drug
Also called CBR-2092
TNP-2092 for injection 100mg/vial
| Study group | Role | What they receive |
|---|---|---|
| TNP-2092 300mg IV | Experimental | TNP-2092 for injection 100mg/vial, 300mg, BID, 1 dose Receives: Drug: TNP-2092 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of TNP-2092 in synovial fluid
Concentration in ng/mL
Measured: 2 hours after infusion
Concentration of TNP-2092 in bone
Concentration in ng/g
Measured: 2 hours after infusion
Secondary outcomes (5)
Plasma PK of a single IV dose of TNP-2092
CTissue: Drug concentration in tissue, ng/mL
Measured: pre-dose, end of infusion, 1 hours, 3 hous, 6 hours, 12 hours and 24 hours after infusion
Plasma PK of a single IV dose of TNP-2092
Cmax: Peak plasma concentration,ng/mL
Measured: pre-dose, end of infusion, 1 hours, 3 hous, 6 hours, 12 hours and 24 hours after infusion
Plasma PK of a single IV dose of TNP-2092
Tmax: Time to maximum plasma concentration, hours
Measured: pre-dose, end of infusion, 1 hours, 3 hous, 6 hours, 12 hours and 24 hours after infusion
Plasma PK of a single IV dose of TNP-2092
AUC0-24: AUC versus time from time 0 to 24 hours, h*ng/mL
Measured: pre-dose, end of infusion, 1 hours, 3 hous, 6 hours, 12 hours and 24 hours after infusion
Rate of adverse event with TNP-2092
Description of adverse events as assessed by CTCAE 4.0
Measured: Day2, Day7, Day14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start1 Mar 2021
- Primary completion31 Dec 2021
- Study completion29 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic Joint InfectionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- TenNor Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294862
- Sponsor's protocol ID
- PJI001-04
- Status last verified
- Oct 2022
- First submitted
- 25 Feb 2020
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate Tissue Distribution, Plasma Pharmacokinetics, Safety, and Tolerability After a Single Intravenous Dose of TNP-2092 in Adult Participants Undergoing Primary Total Hip or Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04294862
- Acronym / sponsor ID
- PJI001-04
- Conditions
- Prosthetic Joint Infection
- Keywords
- TNP-2092, tissue distribution, THA, TKA, safety, PK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- TenNor Therapeutics LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 4 Mar 2020 (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 study will investigate TNP-2092 distribution into joint tissues in participants undergoing a total hip arthroplasty (THA) or a total knee arthroplasty (TKA). Tissue distribution is the primary objective, and plasma pharmacokinetics (PK), safety, and tolerability are secondary objectives.
Detailed description
This is a Phase 1, open-label study to evaluate the tissue distribution, plasma PK, safety, and tolerability after a single 300 mg intravenous (IV) dose of TNP-2092 administered before induction of anesthesia in adult participants undergoing THA or TKA. Sixteen patients who are scheduled to undergo primary THA or TKA will be enrolled.
The enrolled participants who meet the inclusion/exclusion criteria will receive the study intervention (a single 300 mg IV dose of TNP-2092) 2 hours before induction of anesthesia on Day 1. Tissue samples from bone and synovial fluid will be collected during surgery and analyzed for TNP-2092 and cefazolin concentrations. Plasma samples will be collected on Day 1 and Day 2 for PK analysis. Safety and tolerability information will be collected on Day 1 and Day 2 at the clinical center, on Day 7 by phone, and on Day 14 at a final follow-up visit.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TNP-2092 300mg IV | Experimental | Drug: TNP-2092TNP-2092 for injection 100mg/vial, 300mg, BID, 1 dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants are eligible to be included in the study only if all inclusion criteria are met:
- Male or females, 18 years of age or older
- Participants who require primary THA or TKA
- Body mass index (BMI) >=18 kg/m2 but <=40 kg/m2
- Capable of giving signed informed consent
Key exclusion criteria (6 listed)
- Participants are excluded from the study if any of the following exclusion criteria are met:
- History or hypersensitivity or intolerability to any of the following drugs: any member of fluoroquinolones, rifamycin, cefazolin or TNP-2092
- History of known methicillin-resistant Staphylococcus aureus (MRSA) infections
- Presence of any surgical or medical condition that in the opinion of the principal investigator and the medical monitor that could impact the interpretation of the results of the study;
- Evidence of significant hepatic, hematologic or immunologic disease;
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 |
|---|---|---|
| TNP-2092Also: CBR-2092TNP-2092 for injection 100mg/vial | Drug | TNP-2092 300mg IV |
Primary outcome
Concentration of TNP-2092 in synovial fluid
Time frame: 2 hours after infusion
Concentration in ng/mL
Concentration of TNP-2092 in bone
Time frame: 2 hours after infusion
Concentration in ng/g
5 secondary outcomes
Plasma PK of a single IV dose of TNP-2092
Time frame: pre-dose, end of infusion, 1 hours, 3 hous, 6 hours, 12 hours and 24 hours after infusion
Plasma PK of a single IV dose of TNP-2092
Time frame: pre-dose, end of infusion, 1 hours, 3 hous, 6 hours, 12 hours and 24 hours after infusion
Plasma PK of a single IV dose of TNP-2092
Time frame: pre-dose, end of infusion, 1 hours, 3 hous, 6 hours, 12 hours and 24 hours after infusion
Plasma PK of a single IV dose of TNP-2092
Time frame: pre-dose, end of infusion, 1 hours, 3 hous, 6 hours, 12 hours and 24 hours after infusion
Rate of adverse event with TNP-2092
Time frame: Day2, Day7, Day14
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 19 Oct 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 TNP-2092 in people with Prosthetic Joint Infection, run by TenNor Therapeutics Limited 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 5 inclusion and 6 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 19 Oct 2022. 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?
Concentration of TNP-2092 in synovial fluid (time frame: 2 hours after infusion). The study lists 2 primary outcomes in all. 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 19 Oct 2022.