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NCT04294862 · ClinicalTrials.gov registry record · Phase 1

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 of Prosthetic-joint Infection, sponsored by TenNor Therapeutics Limited.

Completed
Registry status
Phase 1
Development phase
13
Enrollment target
1
Study location

NCT04294862 is a Phase 1 study of Prosthetic-joint Infection that has completed, run by TenNor Therapeutics Limited. The registered enrollment target is 13 participants, below the 97-participant average among 9 other Prosthetic-joint Infection trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04294862, a Phase 1 study of Prosthetic-joint Infection, has completed, sponsored by TenNor Therapeutics Limited.

COMPLETED
Registry status
Phase 1
Development phase
13 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • DRUG TNP-2092

Study Locations (1)

Pennsylvania

  • Rothman Orthopedic Institute - Philadelphia

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2021-03-01
Est. Completion 2022-06-29
Phase Phase 1

Sponsor

TenNor Therapeutics Limited

3 total trials

What the Registry Record Tells You About NCT04294862

The ClinicalTrials.gov registry entry for NCT04294862 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 97-participant average among 9 other Prosthetic-joint Infection trials with a reported enrollment target (87% lower). The listed sponsor is TenNor Therapeutics Limited, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Prosthetic-joint Infection appearing as the primary indexed condition, and to 1 intervention - of which TNP-2092 is the first listed.

NCT04294862 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT04294862 about?

NCT04294862 is a clinical study titled "Tissue Distribution, Pharmacokinetics, Safety, and Tolerability After a Single Dose of TNP-2092 in 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.

What is the current status of trial NCT04294862?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2021-03-01. Estimated completion is 2022-06-29.

What conditions does trial NCT04294862 study?

This clinical trial studies the following conditions: Prosthetic-joint Infection.

What interventions are being tested in trial NCT04294862?

The interventions under investigation include: TNP-2092 (DRUG).

Who is sponsoring clinical trial NCT04294862?

This trial is sponsored by TenNor Therapeutics Limited, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04294862 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.