Clinical Trials/NCT04585100

NCT04585100

Unknown

Phase 1

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

Future Medicine5 sites in 1 country64 target enrollmentOctober 7, 2020

ConditionsOcular Hypertension

InterventionsFM101 tablet FM101 oral solution Placebo FM101 150 mg FM101 300 mg

DrugsFM101 tablet FM101 oral solution Placebo FM101 150 mg FM101 300 mg

Overview

Phase: Phase 1
Intervention: FM101 tablet
Conditions: Ocular Hypertension
Sponsor: Future Medicine
Enrollment: 64
Locations: 5
Primary Endpoint: 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.
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 7, 2020

End Date

June 30, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Future Medicine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Sex : Male or female patients.
•Age : 18 to 75 years, inclusive, at screening.
•BMI : 18.0 to 32.0 kg/m
•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.

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.

Arms & Interventions

Bioequivalent test of FM101 oral solution and FM101 tablet

Intervention: FM101 tablet

Bioequivalent test of FM101 oral solution and FM101 tablet

Intervention: FM101 oral solution

Phase 2a

Intervention: Placebo

Phase 2a

Intervention: FM101 150 mg

Phase 2a

Intervention: FM101 300 mg

Outcomes

Primary Outcomes

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.

Time Frame: Day 1 through Day 28

IOP change in the study eye at 12:00 from Baseline to Day 28

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.

Time Frame: Day 1 through Day 37

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.

Time Frame: Day 1 through Day 28

IOP change in the study eye at 8:00 from Baseline to Day 28