None listed
Conditions
Brief summary
The primary objective of Study SCY-247-103 is to evaluate the safety, tolerability, and pharmacokinetic profile of the SCY-247 intravenous formulation following single and multiple intravenous infusion administrations in healthy participants. The results from this study will inform and support dose selection for subsequent clinical studies.
Interventions
Part 1 (SAD):
4 dosing cohorts are planned: Cohorts A, B, C, D.
The starting dose in Part 1 is based on results from pre-clinical pharmacology and toxicology studies. Subsequent dose levels proposed for SAD are preliminary and the actual doses given will be reviewed and confirmed by the SRC based on safety and PK results observed during the study.
Cohort B is planned to include a bioavailability assessment with SCY-247 oral administration (Period 2) at least 21 days after SCY-247 IV administrati
Part 1 (SAD): 4 dosing cohorts are planned: Cohorts A, B, C, D. The starting dose in Part 1 is based on results from pre-clinical pharmacology and toxicology studies. Subsequent dose levels proposed for SAD are preliminary and the actual doses given will be reviewed and confirmed by the SRC based on safety and PK results observed during the study. Cohort B is planned to include a bioavailability assessment with SCY-247 oral administration (Period 2) at least 21 days after SCY-247 IV administration (Period 1). Upto 2 Additional Cohorts may be added in SAD Cohort Reconstituted SCY-247 for Injection Drug Product (IV formulation), diluted in 500mL 0.9%NaCl, infusion duration 2 hrs. A - 50-mg (0.1 mg/mL) or placebo IV QD on Day 1 B -100-mg (0.2 mg/mL) or placebo IV QD on Day 1 (Period 1) 100-mg or placebo oral formulation QD on Day 1 (Period 2) C - 150-mg (0.3 mg/mL) or placebo IV QD on Day 1 D - 200-mg (0.4 mg/mL) or placebo IV QD on Day 1 Participants will receive the same assigned treatment in both Period 1 and Period 2. Part 2 (MAD): Multiple Ascending Dose (MAD) and Transition from IV (Parenteral Infusion) to Oral Administration): 3 dosing cohorts are planned: Cohorts E, F, G Dose levels proposed for MAD are preliminary. The actual start dose will be based on the safety and PK results from SAD cohorts, as well as steady-state modelling. Subsequent dose levels will be based on safety and PK results observed during the study, as well as steady-state modelling. The SRC will review all data and will confirm dose levels. Cohort F and Cohort G are planned to include an IV to oral phase with SCY-247 tablet drug product (oral formulation) administered for 4 days from Day 8 through Day 11. The first oral dose will be administered 24 hours after the start of the last IV infusion. Upto 2 Additional Cohorts may be added in MAD Cohort Reconstituted SCY-247 for Injection Drug Product (IV formulation), diluted in 500mL 0.9%NaCl, infusion duration 2 hrs. E - 50-mg (0.1 mg/mL) or placebo IV QD on Day 1 through Day 7 F - 100-mg (0.2 mg/mL) or placebo IV QD on Day 1 through Day 7 300-mg or placebo oral QD on Day 8 through Day 11 G - 200-mg (0.4 mg/mL) or placebo IV QD on Day 1 through Day 7 300-mg or placebo oral QD on Day 8 through Day 11 Participants will be administered the intervention under confinement in the phase I unit.
Sponsors
SCYNEXIS, Inc.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria ECGs, vital signs, safety labs, urine drug test can be repeated once at the discretion of the investigator. Participant is a healthy male or female aged between 18 to 50 years, inclusive, at the screening visit. 1. Participant has a Body Mass Index (BMI) equal to 32 Kilogram Per Square Meter at the screening visit and body weight between 45.0 Kilogram and 100.0 Kilogram inclusive for females, and between 50.0 Kilogram and 110.0 Kilogram inclusive for males, at the screening visit. 2. Participant is judged to be in good health based on medical history, physical examination, electrocardiogram (ECG), vital sign measurements and laboratory safety testing performed at the screening visit and prior to administration of the initial dose of study drug, in the opinion of the investigator. 3. Participant has been a nonsmoker and/or has not used nicotine or nicotine containing products for at least 6 months; participants who have not discontinued smoking or the use of nicotine/nicotine containing products within 6 months, but who in the past 3 months have smoked 2 cigarettes or equivalent (eg, cigars, vaping, nicotine patches) per week, may be enrolled in the study at the discretion of the investigator. 4. Females must not be pregnant or lactating, and must use acceptable, highly effective double contraception from Screening until 28 days after study completion, including during the Follow-up period. Females with same-sex partners (abstinence from penile-vaginal intercourse) or who are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and Day 1 and be willing to have additional pregnancy tests as required throughout the study. Women not of childbearing potential must be postmenopausal for 12 months (postmenopausal status is to be confirmed through testing of FSH levels equal to 40 International Units per Liter at Screening for amenorrhoeic female participants). Males must be surgically sterile (greater then 30 days since vasectomy with no viable sperm), or if engaged in sexual relations with a WOCBP, either his partner must be surgically sterile (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or an acceptable, highly effective contraceptive method must be used from Screening until study completion, including during the Follow-up period. Males with same-sex partners (abstinence from penile-vaginal intercourse) or are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle. Males must not donate sperm from the first dose of IP until at least 90 days after the last dose of IP.
Exclusion criteria
Key Exclusion Criteria ECGs, vital signs, safety labs, urine drug test can be repeated once at the discretion of the investigator. 1. Underlying psychological medical condition that, in the opinion of the PI, would make it unlikely for the participant to comply with the protocol or complete the study per protocol. 2. Participant has a history of any illness or clinical findings that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant by participation in the study. 3. Participant has insufficient vein access to allow for multiple cannulations. Participant has an estimated creatinine clearance equal to 80 Milliliters per minute based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (assessed at screening). Participants who have an estimated creatinine clearance up to 10 percent below 80 Milliliters per minute may be enrolled in the study at the discretion of the investigator. 4. Participant has risks for QT prolongation including a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTcF interval greater then 450 milliseconds for males and >470 milliseconds for females). 5. Participant is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies (such as St. John’s Wort [hypericum perforatum]) beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study drug, throughout the study (including washout intervals between treatment periods), until the poststudy visit. There may be certain medications eg paracetamol, vitamins, ibuprofen that are permitted at investigator’s discretion. 6. Participant has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 30 days or 5 half-lives (whichever is longest) of the investigational product prior to the screening. The 30-day window will be derived from the date of the last study procedure (i.e., poststudy, AE follow-up, etc.) in the previous study to the screening visit of the current study. 7. Participant has a history of significant multiple and/or severe allergies [including latex allergy, but with exception of seasonal rhinitis (hay fever)] or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food.
Outcome results
None listed