Status:
COMPLETED
Tissue Distribution, Pharmacokinetics, Safety, and Tolerability After a Single Dose of TNP-2092 in Participants Undergoing Primary Total Hip or Knee Arthroplasty
Lead Sponsor:
TenNor Therapeutics Limited
Conditions:
Prosthetic Joint Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ob...
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 an...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04294862
Start Date
March 1 2021
End Date
June 29 2022
Last Update
October 19 2022
Active Locations (1)
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1
Rothman Orthopedic Institute
Philadelphia, Pennsylvania, United States, 19107