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First-in-human, Safety, Tolerability and Pharmacokinetics Study of LRX712 in Osteoarthritic Patients

NCT ID: NCT03355196

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-20

Study Completion Date

2019-03-26

Brief Summary

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This study is designed to evaluate, for the first time in humans, safety and tolerability of single ascending doses of intra-articular (i.a.) injections of LRX712 into the knee of patients with moderate osteoarthritis (OA), in order to support the further clinical development. This study will also allow establishment of the systemic and local pharmacokinetics (PK) of LRX712 and the exploration of biomarkers of cartilage breakdown and regeneration in OA patients.

Detailed Description

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Conditions

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Patients With Moderate Knee Osteoarthritis (30 - 65 Years)

Keywords

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Osteoarthritic patients Cartilage Safety

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LRX712

LRX712 given intra-articularly

Group Type EXPERIMENTAL

LRX712

Intervention Type DRUG

Ascending single dose on Day 1

Placebo

Placebo given intra-articularly

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Ascending single dose on Day 1

Interventions

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LRX712

Ascending single dose on Day 1

Intervention Type DRUG

Placebo

Ascending single dose on Day 1

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female patients, 30 to 65 years of age inclusive, and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
* At screening, and at baseline vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for at least three minutes, and again (when required) after three minutes in the standing position as outlined in the SOM.

Sitting vital signs should be guided by the following ranges:

* body temperature between 35.0-37.5 °C
* systolic blood pressure 90-139 mm Hg
* diastolic blood pressure 50-89 mm Hg
* pulse rate, 40 - 90 bpm • Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 32 kg/m2. BMI = Body weight (kg) / \[Height (m)\]

Exclusion Criteria

* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
* Pregnant or nursing (lactating) women
* Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations
* A history of clinically significant ECG abnormalities, or any of the following ECG abnormalities at screening and baseline

* PR \> 200 msec
* QRS complex \> 120 msec
* QTcF \> 450 msec (males)
* QTcF \> 460 msec (females)
* Known family history or known presence of long QT syndrome
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

Leiden, , Netherlands

Site Status

Countries

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Netherlands

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17606

Results for CLRX712X2101 can be found on the Novartis Clinical Trial Results Website

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=381

A Plain Language Trial Summary is available on novartisclinicatrials.com

Other Identifiers

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CLRX712X2101

Identifier Type: -

Identifier Source: org_study_id