Patients With Moderate Knee Osteoarthritis (30 - 65 Years)Phase 1NCT03355196
First-in-human, Safety, Tolerability and Pharmacokinetics Study of LRX712 in Osteoarthritic Patients
A Phase 1 study testing LRX712 in people with Patients With Moderate Knee Osteoarthritis (30 - 65 Years), run by Novartis Pharmaceuticals at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Patients With Moderate Knee Osteoarthritis (30 - 65 Years)
- What is being tested?
- LRX712
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Nov 2017to 26 Mar 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)]
Who cannot join
- 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
Show all 9Show fewer
- QTcF > 450 msec (males)
- QTcF > 460 msec (females)
- Known family history or known presence of long QT syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo Controlled, Subject and Investigator Blinded, first-in- Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics After Intra-articular Injection of LRX712 Into the Knee of Osteoarthritic Patients
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.
- Being tested
- LRX712, Placebo
- Keywords
- Osteoarthritic patients, Cartilage, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LRX712Drug
Ascending single dose on Day 1
PlaceboDrug
Ascending single dose on Day 1
| Study group | Role | What they receive |
|---|---|---|
| LRX712 | Experimental | LRX712 given intra-articularly Receives: Drug: LRX712 |
| Placebo | Placebo comparator | Placebo given intra-articularly Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of LRX712 after a single intra-articular (i.a.) injection in Osteoarthritic (OA) patients
To evaluate Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of LRX712 after a single i.a. injection in osteoarthritic patients
Measured: Day 29
Secondary outcomes (7)
Time to Reach the Maximum Plasma Concentration (Tmax)
To evaluate LRX712 and metabolite MAE344 pharmacokinetics in plasma - Time to Reach the Maximum Plasma Concentration (Tmax)
Measured: pre-dose to 29 days post-dose
Maximum Observed Plasma Concentration (Cmax)
To evaluate LRX712 and metabolite MAE344 pharmacokinetics in plasma - Maximum Observed Plasma Concentration (Cmax)
Measured: pre-dose to 29 days post-dose
Area Under the Plasma Concentration-time Curve From 0 to the Last Measurable Concentration (AUClast)
To evaluate LRX712 and metabolite MAE344 pharmacokinetics in plasma - Area Under the Plasma Concentration-time Curve From 0 to the Last Measurable Concentration (AUClast)
Measured: pre-dose to 29 days post-dose
Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
To evaluate LRX712 and metabolite MAE344 pharmacokinetics in plasma - Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Measured: pre-dose to 29 days post-dose
Half-life (T1/2)
To evaluate LRX712 and metabolite MAE344 pharmacokinetics in plasma - Half-life (T1/2)
Measured: pre-dose to 29 days post-dose
CL/F - Total clearance
To evaluate LRX712 and metabolite MAE344 pharmacokinetics in plasma - CL/F - Total clearance
Measured: pre-dose to 29 days post-dose
Vz/F - Volume of Distribution
To evaluate LRX712 and metabolite MAE344 pharmacokinetics in plasma - Vz/F - Volume of Distribution
Measured: pre-dose to 29 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start20 Nov 2017
- Primary completion26 Mar 2019
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Moderate Knee Osteoarthritis (30 - 65 Years)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355196
- Sponsor's protocol ID
- CLRX712X2101
- Status last verified
- May 2020
- First submitted
- 17 Nov 2017
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled, Subject and Investigator Blinded, first-in- Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics After Intra-articular Injection of LRX712 Into the Knee of Osteoarthritic Patients
- ClinicalTrials.gov ID
- NCT03355196
- Acronym / sponsor ID
- CLRX712X2101
- Keywords
- Osteoarthritic patients, Cartilage, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 28 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LRX712 | Experimental | Drug: LRX712LRX712 given intra-articularly |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo given intra-articularly |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- body temperature between 35.0-37.5 °C
- systolic blood pressure 90-139 mm Hg
- diastolic blood pressure 50-89 mm Hg
Key exclusion criteria (9 listed)
- 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
- Known family history or known presence of long QT syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LRX712Ascending single dose on Day 1 | Drug | LRX712 |
| PlaceboAscending single dose on Day 1 | Drug | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of LRX712 after a single intra-articular (i.a.) injection in Osteoarthritic (OA) patients
Time frame: Day 29
To evaluate Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of LRX712 after a single i.a. injection in osteoarthritic patients
7 secondary outcomes
Time to Reach the Maximum Plasma Concentration (Tmax)
Time frame: pre-dose to 29 days post-dose
Maximum Observed Plasma Concentration (Cmax)
Time frame: pre-dose to 29 days post-dose
Area Under the Plasma Concentration-time Curve From 0 to the Last Measurable Concentration (AUClast)
Time frame: pre-dose to 29 days post-dose
Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Time frame: pre-dose to 29 days post-dose
Half-life (T1/2)
Time frame: pre-dose to 29 days post-dose
CL/F - Total clearance
Time frame: pre-dose to 29 days post-dose
Vz/F - Volume of Distribution
Time frame: pre-dose to 29 days post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Results for CLRX712X2101 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
- A Plain Language Trial Summary is available on novartisclinicatrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LRX712 in people with Patients With Moderate Knee Osteoarthritis (30 - 65 Years), run by Novartis Pharmaceuticals at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of LRX712 after a single intra-articular (i.a.) injection in Osteoarthritic (OA) patients (time frame: Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.