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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04585100




Registration number
NCT04585100
Ethics application status
Date submitted
7/09/2020
Date registered
14/10/2020
Date last updated
20/07/2022

Titles & IDs
Public title
FM101 Safety, Tolerability, Efficacy Study in the Patients With Ocular Hypertension
Scientific 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
Secondary ID [1] 0 0
FM101-CTP2-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ocular Hypertension 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - FM101 tablet
Treatment: Drugs - FM101 oral solution
Treatment: Drugs - Placebo
Treatment: Drugs - FM101 150 mg
Treatment: Drugs - FM101 300 mg

Experimental: Bioequivalent test of FM101 oral solution and FM101 tablet -

Experimental: Phase 2a -


Treatment: Drugs: FM101 tablet
Bio-equivalent test (tablet vs oral solution)

Treatment: Drugs: FM101 oral solution
Bio-equivalent test (tablet vs oral solution)

Treatment: Drugs: Placebo
Placebo BID for 28 days

Treatment: Drugs: FM101 150 mg
FM101 (150 mg) BID for 28 days

Treatment: Drugs: FM101 300 mg
FM101 (300 mg) BID for 28 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Day 1 through Day 37
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Day 1 through Day 28
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
Day 1 through Day 28

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Norwest Eye Medical Pty Ltd - Bella Vista
Recruitment hospital [2] 0 0
Adelaide Eye & Retina Centre - Adelaide
Recruitment hospital [3] 0 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment hospital [4] 0 0
Eye Surgery Associates - East Melbourne
Recruitment hospital [5] 0 0
Lions Eye Institute - Nedlands
Recruitment postcode(s) [1] 0 0
- Bella Vista
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- East Melbourne
Recruitment postcode(s) [4] 0 0
- Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Future Medicine
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Futuremedicine Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT04585100
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jung Chul Kwon
Address 0 0
Futuremedicine Australia Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kyunghee Kim
Address 0 0
Country 0 0
Phone 0 0
+82222898540
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04585100