A Phase 1 interventional study of TNP-2092 in Prosthetic Joint Infection, sponsored by TenNor Therapeutics Limited. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-19.
Sponsored by TenNor Therapeutics Limited · Phase 1, Interventional, and Other
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.
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.
TenNor Therapeutics Limited is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants are eligible to be included in the study only if all inclusion criteria are met:
Exclusion Criteria:
Participants are excluded from the study if any of the following exclusion criteria are met:
TNP-2092 for injection 100mg/vial, 300mg, BID, 1 dose
Drug: TNP-2092
TNP-2092 for injection 100mg/vial
Also known as: CBR-2092
Concentration of TNP-2092 in synovial fluid
Concentration in ng/mL
Time frame: 2 hours after infusion
Concentration of TNP-2092 in bone
Concentration in ng/g
Time frame: 2 hours after infusion
Plasma PK of a single IV dose of TNP-2092
CTissue: Drug concentration in tissue, ng/mL
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
Cmax: Peak plasma concentration,ng/mL
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
Tmax: Time to maximum plasma concentration, hours
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
AUC0-24: AUC versus time from time 0 to 24 hours, h\*ng/mL
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
Description of adverse events as assessed by CTCAE 4.0
Time frame: Day2, Day7, Day14
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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TenNor Therapeutics Limited