Tissue Distribution, Pharmacokinetics, Safety, and Tolerability After a Single Dose of TNP-2092 in Participants Undergoing Primary Total Hip or Knee Arthroplasty
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
1 other identifier
interventional
13
1 country
1
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 objective, and plasma pharmacokinetics (PK), safety, and tolerability are secondary objectives.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2020
CompletedFirst Posted
Study publicly available on registry
March 4, 2020
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2022
CompletedOctober 19, 2022
October 1, 2022
10 months
February 25, 2020
October 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Concentration of TNP-2092 in synovial fluid
Concentration in ng/mL
2 hours after infusion
Concentration of TNP-2092 in bone
Concentration in ng/g
2 hours after infusion
Secondary Outcomes (5)
Plasma PK of a single IV dose of TNP-2092
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
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
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
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
Day2, Day7, Day14
Study Arms (1)
TNP-2092 300mg IV
EXPERIMENTALTNP-2092 for injection 100mg/vial, 300mg, BID, 1 dose
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rothman Orthopedic Institute
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2020
First Posted
March 4, 2020
Study Start
March 1, 2021
Primary Completion
December 31, 2021
Study Completion
June 29, 2022
Last Updated
October 19, 2022
Record last verified: 2022-10