A SAD, MAD, and FE Study to Evaluate the Safety, Tolerabi... | NCT03879928

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo for SAD	Placebo Comparator	Placebo comparator for SAD	Drug: Single ascending doses of FM101
FM101 75 mg for SAD	Experimental	Single ascending doses of FM101	Drug: Single ascending doses of FM101
FM101 150 mg for SAD	Experimental	Single ascending doses of FM101	Drug: Single ascending doses of FM101
FM101 300 mg for SAD	Experimental	Single ascending doses of FM101	Drug: Single ascending doses of FM101
FM101 600 mg for SAD	Experimental	Single ascending doses of FM101	Drug: Single ascending doses of FM101
FM101 1200 mg for SAD	Experimental	Single ascending doses of FM101

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Single ascending doses of FM101	Drug	The study drug (FM101 and placebo comparator) will be administered orally as SAD doses	FM101 1200 mg for SAD FM101 150 mg for SAD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the safety and tolerability of FM101 after SAD and MAD doses to healthy volunteers by assessing the number, severity, and type of TEAEs.	The number of TEAEs (frequency of occurrence, number of subjects experiencing the event)	SAD [Day 1 through Day 7], MAD [Day 1 through Day 10]
To evaluate the change in clinical laboratory values from the baseline after SAD and MAD doses.	The number of abnormalities with clinical significance (frequency of occurrence, number of subjects experiencing the event)	SAD [Day 1 through Day 7], MAD [Day 1 through Day 10]
To evaluate the change in vital signs from the baseline after SAD and MAD doses.	The number of abnormalities with clinical significance (frequency of occurrence, number of subjects experiencing the event)	SAD [Day 1 through Day 7], MAD [Day 1 through Day 10]
To evaluate the change in electrocardiograms (ECGs) after SAD and MAD doses.	The number of abnormalities with clinical significance (frequency of occurrence, number of subjects experiencing the event).	SAD [Day 1 through Day 7], MAD [Day 1 through Day 10]
To evaluate the change in physical examinations after SAD and MAD doses.	The number of abnormalities with clinical significance (frequency of occurrence, number of subjects experiencing the event).	SAD [Day 1 through Day 7], MAD [Day 1 through Day 10]
To assess maximum observed plasma concentration (Cmax) following SAD and MAD doses	Cmax of FM101 in plasma will be calculated as applicable: SAD phase - cohort 1 to 6 , MAD phase - cohort 2

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the effect of food on the plasma Cmax of FM101 after a single dose	Cmax of FM101 under fasted and fed conditions will be calculated after a single dose.	Day 1 pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 15, 24, 36, 48, and 72 hours post-dose.
To evaluate the effect of food on the plasma AUClast of FM101 after a single dose

Other Outcomes

Measure	Description	Time Frame
Urine concentrations of FM101 in MAD cohort 2	Cmax of FM101 in the urine will be calculated. MAD phase - cohort 2	MAD phase - At pre-dose (within 12 hours prior to dosing), and over 0-6, 6-12, 12-18, and 18-24 hours post-dose collection intervals on Day 1 and Day 7.
Urine concentrations of M6, FM101's metabolite in MAD cohort 2

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Gender: male or female
Age: 18 - 50 years, inclusive, at screening
Body mass index (BMI) : 18.0 - 32.0 kg/m2 (inclusive)
Weight : ≥ 50 kg
Status : healthy subjects
At screening, females must be non-pregnant and non-lactating, or of non child-bearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1 year post menopausal [amenorrhea duration of 12 consecutive months); non-pregnancy will be confirmed for all females by a serum pregnancy test conducted at screening, and a urine pregnancy test at each admission and at follow-up.
Female subjects of child-bearing potential, with a fertile male sexual partner, must agree to use adequate contraception from screening until 90 days after the follow up visit. Adequate contraception is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom. Also, total abstinence, in accordance with the lifestyle of the subject, is acceptable.
Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from first admission to the clinical research center until 90 days after the follow-up visit. Adequate contraception for the male subject (and his female partner) is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom. Also, total abstinence, in accordance with the lifestyle of the subject is acceptable.
All prescribed medication must have been stopped at least 14 days prior to (each) admission to the clinical research center. An exception is made for hormonal contraceptives, which may be used throughout the study.
All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's Wort) must have been stopped at least 7 days prior to (each) admission to the clinical research center. An exception is made for paracetamol, which is allowed up to admission to the clinical research center.
Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks), grapefruit (juice), and tobacco products from 48 hours prior to (each) admission to the clinical research center.
Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator.
Willing and able to sign the ICF.

Exclusion Criteria:

Employee of CRO or the Sponsor.
History of relevant drug and/or food allergies.
Using tobacco products within 60 days prior to (the first) drug administration.
History of alcohol abuse or drug addiction (including soft drugs like cannabis products).
Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, gamma hydroxybutyric acid [GHB], tricyclic antidepressants, and alcohol) at screening and (each) admission to the clinical research center.
Average intake of more than 24 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
Positive screen for hepatitis B surface antigen (HBsAg), anti hepatitis C virus (HCV) antibodies, or anti human immunodeficiency virus (HIV) 1 and 2 antibodies.
Participation in a drug study within 60 days prior to (the first) drug administration in the current study. Participation in more than 3 other drug studies (for male subjects) / more than 2 other drug studies (for female subjects) in the 10 months prior to (the first) drug administration in the current study.
Donation or loss of more than 100 mL of blood within 60 days prior to (the first) drug administration. Donation or loss of more than 1.5 liters of blood (for male subjects) / more than 1.0 liters of blood (for female subjects) in the 10 months prior to (the first) drug administration in the current study.
Significant and/or acute illness within 5 days prior to (the first) drug administration that may impact safety assessments, in the opinion of the Investigator.
Non-willingness to consume the high-fat breakfast (Part B only).
Unsuitable veins for infusion or blood sampling.](streamdown:incomplete-link)

Name	Affiliation	Role
WanSeok Jeong, MBA	Future Medicine Ltd.	Study Chair
Renger Tiessen, PhD	PRA Health Sciences	Principal Investigator