FM101 Safety, Tolerability, Efficacy Study in the Patients With Ocular Hypertension
Primary Purpose
Ocular Hypertension
Status
Recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
FM101 tablet
FM101 oral solution
Placebo
FM101 150 mg
FM101 300 mg
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Hypertension focused on measuring Ocular Hypertension, OHT, FM101
Eligibility Criteria
Inclusion Criteria:
- Sex : Male or female patients.
- Age : 18 to 75 years, inclusive, at screening.
- BMI : 18.0 to 32.0 kg/m2.
- Weight : ≥50 kg.
- Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or use highly effective contraceptive method (oral contraceptive pills [OCPs], long-acting implantable hormones, injectable hormones, a vaginal ring or an intrauterine device [IUD]) from screening until study completion, including the follow-up period for at least 90 days after the last dose of study drug, or be post-menopausal for ≥12 months. Post-menopausal status will be confirmed through testing of FSH levels (≥30 IU/mL) at screening for amenorrheic female participants. Females who are abstinent from heterosexual intercourse will also be eligible.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and admission and be willing to have additional pregnancy tests as required throughout the study.
- Males must be surgically sterile (>30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a WOCBP, the participant and his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or using an acceptable, highly effective contraceptive method from screening until study completion, including the follow-up period, for at least 90 days after the last dose of study drug. Male participants whose female partner is post-menopausal, and participants who are abstinent from heterosexual intercourse will also be eligible. Male participants must agree to refrain from donating sperm from screening until study completion, including the follow-up period, for at least 90 days after the last dose of study drug.
- Willing and able to participate in the study, give written informed consent, and comply with the study procedures.
- Diagnosis of OHT in at least 1 eye, not currently receiving medication for raised IOP or able to stop such medication for a washout period and the duration of the study.
- Elevated IOP (≥24 and ≤32 mmHg at 08:00 hours, and ≥21 and ≤32 mmHg at 12:00 hours) on baseline visit in at least one eye off treatment.
- Anterior chamber is open and non-occludable (both eyes) as confirmed by Investigator by gonioscopy examination at screening.
Exclusion Criteria:
- Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the Investigator judges as likely to interfere with the objectives of the trial or the safety of the patient.
- Female patients who are pregnant, nursing, or planning a pregnancy. The absence of pregnancy will be confirmed for all female patients by a serum pregnancy test conducted at screening, and a urine pregnancy test on Day -1 and at follow-up.
- Patients with known or suspected drug or alcohol abuse.
- Current enrollment or past participation within the last 30 days before the screening visit in any other clinical study involving an investigational study treatment or any type of medical research.
- Patients with a history of poor study drug compliance, protocol non-compliance, or prohibited medication intake.
- Patients with a history or presence of uncontrolled, chronic, generalized, systemic, or other disease that the Investigator feels might increase the risk to the safety of the patient or confound the results of the study.
- Surgery (e.g., stomach bypass) or medical condition that might significantly affect absorption of medicines (as judged by the Investigator).
- Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
- Patients requiring concomitant medication (either systemic or topical) known to affect IOP (e.g., beta-blockers, calcium channel blockers, ACE inhibitors, CAIs, or corticosteroids). However, systemic antihypertensive medications are allowed as long as the dose and regimen have been stable for at least 3 months prior to screening and are expected to remain stable throughout the study.
- Receiving more than one medication for IOP at time of screening.
- Patients who used inhibitors or inducers of cytochrome P450 3A4 in the last 30 days.
- Uncontrolled intraocular hypertension in any eye defined as >30 mmHg at either of the screening/baseline visits (after a washout phase in those patients who were currently receiving ocular hypotensive therapy).
- Central corneal thickness of less than 500 µm or greater than 620 µm.
- BCVA worse than 20/200 in either eye.
- Any corneal abnormality or other condition interfering or preventing reliable Goldmann applanation tonometry (e.g., Fuchs dystrophy or significant corneal surface abnormality).
- Advanced glaucoma (e.g., cup/disc ratio >0.80), evidence of significant visual field defect that would be at risk for progression during the wait/washout period, or progressive visual field loss within the last year.
- Any other forms of glaucoma (e.g angle closure glaucoma, normal tension glaucoma, congenital glaucoma, etc), other than OAG or OHT.
- Use of contact lenses within one week prior to Day 1 until end of treatment.
- Patients with history of severe ocular trauma in either eye.
- Previous complicated surgery or glaucoma surgery or laser treatment of any kind in either eye.
- Presence of any active severe external ocular disease, inflammation, or infection of the eye and/or eyelids.
- History of retinal detachment, proliferative diabetic retinopathy, or any retinal disease that may be progressive during the time course of the study.
- Presence of clinically significant macular edema.
- Any ocular disease or condition that in the opinion of the study Investigator may put the patient at significant risk, may confound study results, or may interfere significantly with the patient's participation in the study.
- Donation or loss of more than 450 mL blood during the 3 months before the start of screening.
- Known allergy, hypersensitivity, or contraindications to FM101.
- Positive screen for HBsAg, HCV antibodies, or anti-HIV 1 and 2 antibodies.
- Any other condition that would confound the study or endanger the safety of the patient as per the judgment of the Investigator.
Sites / Locations
- Norwest Eye Medical Pty LtdRecruiting
- Adelaide Eye & Retina CentreRecruiting
- CMAX Clinical Research Pty Ltd
- Eye Surgery AssociatesRecruiting
- Lions Eye InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Bioequivalent test of FM101 oral solution and FM101 tablet
Phase 2a
Arm Description
Outcomes
Primary Outcome Measures
To assess the safety and tolerability of two dose levels of FM101 after repeated dosing in patients with OAG or OHT compared to that of placebo.
The number of TEAEs (frequency of occurrence, number of subjects experiencing the event)
To assess the effect of two dose levels of FM101 in oral tablet formulation on the change from baseline intraocular pressure (IOP) in the study eye at 08:00 hours, after 28 days of repeated dosing in patients with OHT compared to that of placebo.
IOP change in the study eye at 8:00 from Baseline to Day 28
To assess the effect of two dose levels of FM101 in oral tablet formulation on the change from baseline intraocular pressure (IOP) in the study eye at 12:00 hours, after 28 days of repeated dosing in patients with OHT compared to that of placebo.
IOP change in the study eye at 12:00 from Baseline to Day 28
Secondary Outcome Measures
Full Information
NCT ID
NCT04585100
First Posted
September 7, 2020
Last Updated
July 18, 2022
Sponsor
Future Medicine
Collaborators
Futuremedicine Australia
1. Study Identification
Unique Protocol Identification Number
NCT04585100
Brief Title
FM101 Safety, Tolerability, Efficacy Study in the Patients With Ocular Hypertension
Official Title
Phase 1/2a, Randomized, Double-Masked, Placebo-Controlled, Multi-center Study Assessing the Safety, Tolerability, And Efficacy Of FM101 In Patients With Ocular Hypertension, And To Assess The Relative Bioavailability Of The FM101 Oral Tablet Formulation In Healthy Participants
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Future Medicine
Collaborators
Futuremedicine Australia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A PHASE 1/2A, RANDOMIZED, DOUBLE-MASKED, PLACEBO-CONTROLLED, MULTI-CENTER STUDY ASSESSING THE SAFETY, TOLERABILITY, AND EFFICACY OF FM101 IN PATIENTS WITH OCULAR HYPERTENSION, AND TO ASSESS THE RELATIVE BIOAVAILABILITY OF THE FM101 ORAL TABLET FORMULATION IN HEALTHY PARTICIPANTS
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension
Keywords
Ocular Hypertension, OHT, FM101
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bioequivalent test of FM101 oral solution and FM101 tablet
Arm Type
Experimental
Arm Title
Phase 2a
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
FM101 tablet
Intervention Description
Bio-equivalent test (tablet vs oral solution)
Intervention Type
Drug
Intervention Name(s)
FM101 oral solution
Intervention Description
Bio-equivalent test (tablet vs oral solution)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo BID for 28 days
Intervention Type
Drug
Intervention Name(s)
FM101 150 mg
Intervention Description
FM101 (150 mg) BID for 28 days
Intervention Type
Drug
Intervention Name(s)
FM101 300 mg
Intervention Description
FM101 (300 mg) BID for 28 days
Primary Outcome Measure Information:
Title
To assess the safety and tolerability of two dose levels of FM101 after repeated dosing in patients with OAG or OHT compared to that of placebo.
Description
The number of TEAEs (frequency of occurrence, number of subjects experiencing the event)
Time Frame
Day 1 through Day 37
Title
To assess the effect of two dose levels of FM101 in oral tablet formulation on the change from baseline intraocular pressure (IOP) in the study eye at 08:00 hours, after 28 days of repeated dosing in patients with OHT compared to that of placebo.
Description
IOP change in the study eye at 8:00 from Baseline to Day 28
Time Frame
Day 1 through Day 28
Title
To assess the effect of two dose levels of FM101 in oral tablet formulation on the change from baseline intraocular pressure (IOP) in the study eye at 12:00 hours, after 28 days of repeated dosing in patients with OHT compared to that of placebo.
Description
IOP change in the study eye at 12:00 from Baseline to Day 28
Time Frame
Day 1 through Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Sex : Male or female patients.
Age : 18 to 75 years, inclusive, at screening.
BMI : 18.0 to 32.0 kg/m2.
Weight : ≥50 kg.
Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or use highly effective contraceptive method (oral contraceptive pills [OCPs], long-acting implantable hormones, injectable hormones, a vaginal ring or an intrauterine device [IUD]) from screening until study completion, including the follow-up period for at least 90 days after the last dose of study drug, or be post-menopausal for ≥12 months. Post-menopausal status will be confirmed through testing of FSH levels (≥30 IU/mL) at screening for amenorrheic female participants. Females who are abstinent from heterosexual intercourse will also be eligible.
Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and admission and be willing to have additional pregnancy tests as required throughout the study.
Males must be surgically sterile (>30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a WOCBP, the participant and his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or using an acceptable, highly effective contraceptive method from screening until study completion, including the follow-up period, for at least 90 days after the last dose of study drug. Male participants whose female partner is post-menopausal, and participants who are abstinent from heterosexual intercourse will also be eligible. Male participants must agree to refrain from donating sperm from screening until study completion, including the follow-up period, for at least 90 days after the last dose of study drug.
Willing and able to participate in the study, give written informed consent, and comply with the study procedures.
Diagnosis of OHT in at least 1 eye, not currently receiving medication for raised IOP or able to stop such medication for a washout period and the duration of the study.
Elevated IOP (≥24 and ≤32 mmHg at 08:00 hours, and ≥21 and ≤32 mmHg at 12:00 hours) on baseline visit in at least one eye off treatment.
Anterior chamber is open and non-occludable (both eyes) as confirmed by Investigator by gonioscopy examination at screening.
Exclusion Criteria:
Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the Investigator judges as likely to interfere with the objectives of the trial or the safety of the patient.
Female patients who are pregnant, nursing, or planning a pregnancy. The absence of pregnancy will be confirmed for all female patients by a serum pregnancy test conducted at screening, and a urine pregnancy test on Day -1 and at follow-up.
Patients with known or suspected drug or alcohol abuse.
Current enrollment or past participation within the last 30 days before the screening visit in any other clinical study involving an investigational study treatment or any type of medical research.
Patients with a history of poor study drug compliance, protocol non-compliance, or prohibited medication intake.
Patients with a history or presence of uncontrolled, chronic, generalized, systemic, or other disease that the Investigator feels might increase the risk to the safety of the patient or confound the results of the study.
Surgery (e.g., stomach bypass) or medical condition that might significantly affect absorption of medicines (as judged by the Investigator).
Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
Patients requiring concomitant medication (either systemic or topical) known to affect IOP (e.g., beta-blockers, calcium channel blockers, ACE inhibitors, CAIs, or corticosteroids). However, systemic antihypertensive medications are allowed as long as the dose and regimen have been stable for at least 3 months prior to screening and are expected to remain stable throughout the study.
Receiving more than one medication for IOP at time of screening.
Patients who used inhibitors or inducers of cytochrome P450 3A4 in the last 30 days.
Uncontrolled intraocular hypertension in any eye defined as >30 mmHg at either of the screening/baseline visits (after a washout phase in those patients who were currently receiving ocular hypotensive therapy).
Central corneal thickness of less than 500 µm or greater than 620 µm.
BCVA worse than 20/200 in either eye.
Any corneal abnormality or other condition interfering or preventing reliable Goldmann applanation tonometry (e.g., Fuchs dystrophy or significant corneal surface abnormality).
Advanced glaucoma (e.g., cup/disc ratio >0.80), evidence of significant visual field defect that would be at risk for progression during the wait/washout period, or progressive visual field loss within the last year.
Any other forms of glaucoma (e.g angle closure glaucoma, normal tension glaucoma, congenital glaucoma, etc), other than OAG or OHT.
Use of contact lenses within one week prior to Day 1 until end of treatment.
Patients with history of severe ocular trauma in either eye.
Previous complicated surgery or glaucoma surgery or laser treatment of any kind in either eye.
Presence of any active severe external ocular disease, inflammation, or infection of the eye and/or eyelids.
History of retinal detachment, proliferative diabetic retinopathy, or any retinal disease that may be progressive during the time course of the study.
Presence of clinically significant macular edema.
Any ocular disease or condition that in the opinion of the study Investigator may put the patient at significant risk, may confound study results, or may interfere significantly with the patient's participation in the study.
Donation or loss of more than 450 mL blood during the 3 months before the start of screening.
Known allergy, hypersensitivity, or contraindications to FM101.
Positive screen for HBsAg, HCV antibodies, or anti-HIV 1 and 2 antibodies.
Any other condition that would confound the study or endanger the safety of the patient as per the judgment of the Investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyunghee Kim
Phone
+82222898540
Email
kkh@futuremedicine.co.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Saehan Kang
Phone
+82232873805
Email
saehan@futuremedicine.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung Chul Kwon
Organizational Affiliation
Futuremedicine Australia Pty Ltd
Official's Role
Study Chair
Facility Information:
Facility Name
Norwest Eye Medical Pty Ltd
City
Bella Vista
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tariq Yasser, Dr
Facility Name
Adelaide Eye & Retina Centre
City
Adelaide
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jagjit (Jolly) S Gilhotra, Dr
Phone
+61 8 8212 3022
Facility Name
CMAX Clinical Research Pty Ltd
City
Adelaide
Country
Australia
Individual Site Status
Completed
Facility Name
Eye Surgery Associates
City
East Melbourne
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathan Kerr, Dr
Phone
+61 3 9998 8337
Facility Name
Lions Eye Institute
City
Nedlands
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antony Clark, Dr
12. IPD Sharing Statement
Learn more about this trial
FM101 Safety, Tolerability, Efficacy Study in the Patients With Ocular Hypertension
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