None listed
Conditions
Brief summary
Cohorts 2 and 3 are double-blind, randomized, placebo-controlled studies evaluating the safety, tolerability, and PK of multiple SCY-770 doses in 8 participants (3:1 randomization). Progression to Cohort 3 depends on SRC review of Cohort 2 data. Cohort 3 uses sentinel dosing, with 2 participants dosed first, followed by the remaining 6 participants if safety is confirmed. Cohort 2 – SCY-770 750mg QD for 7 days Cohort 3 – SCY-770 500mg BID for 6 days and SCY-770 500mg QD on Day 7:
Interventions
SCY770 will be provided as tablets for oral administration with 240ml of room temperature water and the same will be matched for Placebo
This study includes three parts (cohorts) and is conducted in healthy participants. Subjects will not be repeated for any of the cohorts
Cohorts 2 and 3 are double-blind, randomized, placebo-controlled studies to evaluate the safety, tolerability, and pharmacokinetics of repeated doses of SCY-770. Each cohort will include 8 participants (3:1ratio of SCY-770
SCY770 will be provided as tablets for oral administration with 240ml of room temperature water and the same will be matched for Placebo This study includes three parts (cohorts) and is conducted in healthy participants. Subjects will not be repeated for any of the cohorts Cohorts 2 and 3 are double-blind, randomized, placebo-controlled studies to evaluate the safety, tolerability, and pharmacokinetics of repeated doses of SCY-770. Each cohort will include 8 participants (3:1ratio of SCY-770 to placebo). In Cohort 2, participants will receive 750 mg once daily for 7 days. In Cohort 3, participants will receive 500 mg twice daily for 6 days, followed by 500 mg once on Day 7.Dosing will begin with 2 participants (1 active, 1 placebo), and if safe, the remaining participants will be dosed after at least 2 days. Safety data from Cohort 2 will be reviewed before starting Cohort 3.
Sponsors
SCYNEXIS, Inc.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
- The participant should be a healthy man or woman between 18 and 50 years old. - Their body weight and body mass index (BMI) should be within a healthy range. - The participant should be in good overall health, based on medical history, physical check-up, hearttracing (ECG), vital signs, and lab test results. - The participant should not be a smoker and should not have used nicotine products for at least 6 months.In some cases, very occasional smoking (up to 2 cigarettes per week in the last 3 months) may still beallowed if the doctor agrees. - The participant must clearly understand the study and agree to take part by signing a consent form. - The participant must be willing to follow all study rules and stay in the study until it is completed. - The participant should not have any special diet restrictions that would interfere with fasting or eatingstandardized meals provided during the study. - Women should not be pregnant or breastfeeding. - Women who can become pregnant must use highly effective birth control during the study and for 28days after it ends, and must have negative pregnancy tests before and during the study. - Men must either be surgically sterile or use effective contraception if their partner can become pregnant.They must also not donate sperm during the study and for 90 days after the last dose.
Exclusion criteria
- If a person has any mental health condition that may make it difficult for them to follow the study rules orcomplete the study, they will not be included. - If a person has any past illness or medical condition that could affect the study results or makeparticipation unsafe, they will not be included. - People who have had a fever (above 38degree Celsius) or any infection in the past 2 weeks will not beincluded. - People who have difficulty swallowing tablets will not be included. - People with reduced kidney function (based on a blood test) may not be included, unless the studydoctor believes it is still safe. - People with heart rhythm issues (such as prolonged QT interval [QT interval = time taken for the heart tobeat and prepare for the next beat.]) or conditions that may increase the risk of serious irregular heartbeatwill not be included. - People with a family history of certain heart rhythm disorders (like Long QT Syndrome = Long QTSyndrome = a condition where the heart takes too long to reset between beats) may not be included. - People who cannot stop taking medications (including herbal or over-the-counter medicines) before andduring the study will not be included. Some simple medications like paracetamol or vitamins may beallowed if the doctor approves. - People with a history of stroke, seizures, or serious brain-related conditions will not be included. - People with significant medical conditions affecting organs such as the heart, lungs, kidneys, liver,digestive system, immune system, or blood will not be included. In some cases, minor past conditions (likekidney stones or childhood asthma) may still be allowed if the doctor agrees. - People with a history of cancer will not be included, except for certain minor skin cancers or cervicalconditions that were successfully treated many years ago. - People with liver disease or abnormal liver test results may not be included, unless repeat tests areacceptable and approved by the doctor. - People who have infections such as HIV, hepatitis B, or hepatitis C will not be included.
Outcome results
None listed