Healthy VolunteersPhase 1NCT04322175

Pharmacokinetic and Tolerance Study of Meloxicam Eye Drops in Healthy Volunteers

A Phase 1 study testing Meloxicam in people with Healthy Volunteers, run by Beijing Tongren Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Meloxicam
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteChina
Study dates: 16 Dec 2019to 1 Jul 2020
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 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Voluntarily participate in this trial and sign the informed consent before the trial;
Age: 18 to 45 years old (including 18 and 45 years old) healthy subjects, both male and female;
Weight and body mass index: female subjects weigh ≥45.0kg and male subjects weigh ≥50.0kg,BMI is in the range of 19 ～ 26 kg / m2 (including 19 and 26);
Physical examination, vital signs, laboratory examination and ECG examination during the screening period are normal or different Often without clinical significance;
The corrected visual acuity of both eyes should be ≥1.0. The intraocular pressure, slit lamp, and fundus examination are normal or abnormal. It has no clinical significance. The target eye SchirmerⅠ test result during the screening period is ≥10 mm;
Subjects were able to communicate well with the researcher and understood and were willing to comply with the requirements of this study.

Who cannot join

Allergic constitution, allergic diseases or known allergies to research drugs / similar drugs;
Past or current suffering from circulatory system, respiratory system, digestive system, blood system,Menstrual system, immune system, urinary system, endocrine system, and mental illness may be significant Any condition that affects the absorption, distribution, metabolism, and excretion of the drug or affects the safety of the subject;
People with eye diseases, including history of internal eye surgery or laser surgery;
Infection screening is abnormal and clinically significant;
Used any medicine in the last 2 weeks;
Underwent surgery within 4 weeks prior to the trial, or plan to perform surgery within 2 weeks of the end of the study surgeon;

Show all 14Show fewer

Those who need to wear contact lenses during the trial;
A history of substance abuse, or a positive urine test for substance abuse(Ketamine, morphine, methamphetamine, dimethylene oxyamphetamine, tetrahydrocannabinol);
Women with a positive blood pregnancy test; women who have not taken effective contraception in the last month,Pregnant and lactating women; women and men of childbearing age who cannot take effective contraception during the trial and within six months after the trial is over;
Smokers and alcoholics (smokers on average more than 5 cigarettes / day, alcohol consumption on average 2 units / day, 1unit = 10 mL of ethanol, ie 1 unit = 200 mL of beer with 5% alcohol or 25mL of white wine with 40% alcohol or 83mL of wine with 12% alcohol) or a positive breath test, or during the study Stop using any tobacco products and not stop alcohol intake;
Those who donated more than 200 mL of blood in the 90 days before the test, or lost blood of more than 200 mL for other reasons;
Participants in any other clinical trials within 90 days before screening;
Subjects refused to discontinue any use of methyl groups 48 hours before the end of the study until the end of the study xanthine drinks or foods, such as caffeine (coffee, tea, cola, chocolate, etc.), and beverages containing grapefruit;
Any other condition that the investigator considers inappropriate.

Trial locations and contacts

1 site in 1 country.

China1 site

Institution of Drug Clinical Trials
Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: Pharmacokinetics and Tolerance of Meloxicam Eye Drops in Healthy Volunteers, a Phase I , Single-dose and Multiple-dose, Open-labeled Clinical Trial

The pharmacokinetics, safety, and tolerability of meloxicam eye drops in Chinese healthy volunteers were evaluated to provide a basis for the formulation of a phase II clinical trial dosing regimen for this product. Including pre-tests and formal trials, formal trials include single-dose pharmacokinetics tests and multiple-dose tolerance tests (4 times a day for 3 consecutive days).

Read the detailed description

Meloxicam eye drops is a new class 2 drug of the country. The main ingredients are meloxicam. The other ingredients are hydroxypropyl-β-cyclodextrin, sodium hydroxide, boric acid, sodium chloride and water for injection. Among them, hydroxypropyl-β-cyclodextrin can increase the solubility of meloxicam and improve the stability of the solution. The indication of meloxicam eye drops is non-infectious ocular inflammation, especially for inflammation and complications after cataract surgery. The possible adverse reaction is transient tingling in the eye after eye drops.

Meloxicam is a non-steroidal anti-inflammatory drug (NSAIDS) that selectively inhibits COX-2 cyclooxygenase. It is currently widely used in the treatment of acute and chronic inflammation and pain, and its mechanism of action is to prevent the production of prostaglandins (PGs) that cause inflammation by inhibiting cyclooxygenase (COX). Non-infectious ocular inflammation is usually caused by the synthesis and release of inflammatory mediators such as prostaglandin (PG) after eye tissues are stimulated. Because non-steroidal anti-inflammatory drugs have anti-inflammatory, anti-allergic and analgesic effects, and have no adverse effects of glucocorticoids, their application in ophthalmology has been valued.

Conditions: Healthy Volunteers
Being tested: Meloxicam
Keywords: Pharmacokinetics, Tolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MeloxicamDrug
Also called Mobic
Meloxicam Eye Drops

Study groups in NCT04322175
Study group	Role	What they receive
Single dose pharmacokinetic test	Experimental	The 72 healthy subjects enrolled were admitted to the trial ward the day before the trial. On the day of dosing, the subjects were given 0.1% meloxicam eye drops once, 1 drop / time. Receives: Drug: Meloxicam
Multiple dose tolerance test	Experimental	Eight healthy subjects were enrolled in the trial ward the day before the trial. 0.1% meloxicam eye drops were administered 4 times, 1 drop / time, and were administered at 8:00, 12:00, 16:00 and 20:00 daily for 3 consecutive days. Receives: Drug: Meloxicam

What is being measured

The primary outcome is the main question the study is designed to answer.

Concentration of drug prototype-meloxicam in tears of each subject, ng · h / ml
In a single administration test, tear samples were collected 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after administration, and 8 eyes were taken at each time point.LC-MS
Measured: 2 days
Intraocular pressure examination,mmHg
In the multiple dose tolerance test, IOP was performed 2 hours (± 20min) after the second dose of Day2.
Measured: 1 day
Corneal fluorescence staining,levels
Corneal fluorescence staining during the multiple dose tolerance test (Day1-Day3) 1 h after the last daily dose (time window ± 10 min).
Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Dec 20191 Jul 2020

First posted26 Mar 2020
Study start16 Dec 2019
Primary completion1 Jun 2020 (estimated)
Study completion1 Jul 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Beijing Tongren HospitalThe 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04322175
Sponsor's protocol ID: MLXKDYY
Status last verified: Apr 2020
First submitted: 18 Mar 2020
Last updated: 28 Apr 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain

All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics and Tolerance of Meloxicam Eye Drops in Healthy Volunteers, a Phase I , Single-dose and Multiple-dose, Open-labeled Clinical Trial
ClinicalTrials.gov ID: NCT04322175
Acronym / sponsor ID: MLXKDYY
Conditions: Healthy Volunteers
Keywords: Pharmacokinetics, Tolerance
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 80 participants (estimated)
Lead sponsor: Beijing Tongren HospitalUniversity, hospital or other
Study start: 16 Dec 2019 (actual)
Primary completion: 1 Jun 2020 (estimated)
Study completion: 1 Jul 2020 (estimated)
First posted: 26 Mar 2020 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Single dose pharmacokinetic test	Experimental	Drug: MeloxicamThe 72 healthy subjects enrolled were admitted to the trial ward the day before the trial. On the day of dosing, the subjects were given 0.1% meloxicam eye drops once, 1 drop / time.
Multiple dose tolerance test	Experimental	Drug: MeloxicamEight healthy subjects were enrolled in the trial ward the day before the trial. 0.1% meloxicam eye drops were administered 4 times, 1 drop / time, and were administered at 8:00, 12:00, 16:00 and 20:00 daily for 3 consecutive days.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Voluntarily participate in this trial and sign the informed consent before the trial;
Age: 18 to 45 years old (including 18 and 45 years old) healthy subjects, both male and female;
Weight and body mass index: female subjects weigh ≥45.0kg and male subjects weigh ≥50.0kg,BMI is in the range of 19 ～ 26 kg / m2 (including 19 and 26);
Physical examination, vital signs, laboratory examination and ECG examination during the screening period are normal or different Often without clinical significance;
The corrected visual acuity of both eyes should be ≥1.0. The intraocular pressure, slit lamp, and fundus examination are normal or abnormal. It has no clinical significance. The target eye SchirmerⅠ test result during the screening period is ≥10 mm;

Key exclusion criteria (14 listed)

Allergic constitution, allergic diseases or known allergies to research drugs / similar drugs;
Past or current suffering from circulatory system, respiratory system, digestive system, blood system,Menstrual system, immune system, urinary system, endocrine system, and mental illness may be significant Any condition that affects the absorption, distribution, metabolism, and excretion of the drug or affects the safety of the subject;
People with eye diseases, including history of internal eye surgery or laser surgery;
Infection screening is abnormal and clinically significant;
Used any medicine in the last 2 weeks;

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
MeloxicamAlso: MobicMeloxicam Eye Drops	Drug	Multiple dose tolerance test, Single dose pharmacokinetic test

Primary outcome

Concentration of drug prototype-meloxicam in tears of each subject, ng · h / ml
Time frame: 2 days
In a single administration test, tear samples were collected 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after administration, and 8 eyes were taken at each time point.LC-MS
Intraocular pressure examination,mmHg
Time frame: 1 day
In the multiple dose tolerance test, IOP was performed 2 hours (± 20min) after the second dose of Day2.
Corneal fluorescence staining,levels
Time frame: 3 days
Corneal fluorescence staining during the multiple dose tolerance test (Day1-Day3) 1 h after the last daily dose (time window ± 10 min).

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.

Related trials for Healthy Volunteers

Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain

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.

Xiuli Zhao, Ph.D. principal investigator

Beijing Tongren Hospital, Capital Medical Univsersity

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 Meloxicam in people with Healthy Volunteers, run by Beijing Tongren Hospital at 1 site in China.

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 6 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 28 Apr 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 China. 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. 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?

Results are not available in the source record.

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?

Concentration of drug prototype-meloxicam in tears of each subject, ng · h / ml (time frame: 2 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04322175.

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 28 Apr 2020.