None listed
Conditions
Brief summary
Cohort 1 (single-dose food effect evaluation) follows a randomized crossover design comprising three treatments, with a 4-day washout period between administrations of SCY-770 (administered on Study Days 1, 5, and 9): Treatment 1: Single 500 mg dose of SCY-770 under fasted conditions Treatment 2: Single 500 mg dose administered 15 minutes before the start of a standardized breakfast, to be consumed within 30 minutes Treatment 3: Single 500 mg dose administered 30 minutes after the start of a standardized breakfast, to be consumed within 30 minutes Upon completion of Cohort 1, the Sponsor will determine the dosing regimen for Cohorts 2 and 3 based on Cohort 1 PK results. The finalized dosing instructions will be documented in a Protocol Clarification Letter (PCL) and in Version 2 of the Study Pharmacy Manual, without requiring a protocol amendment.
Interventions
SCY-770 will be provided as tablets for oral administration with 240ml of room temperature water.
Standardized meals will be provided while participants are in the Clinical Research Unit per Clinical Research Unit Standard Operating Procedure.
Treatment 2: Single 500 mg dose of SCY-770 administered 15 minutes prior to the start of a standardized breakfast, which should be consumed within 30 minutes.
Treatment 3: Single 500 mg dose of SCY-770 administered 30 minutes after the start of a standar
SCY-770 will be provided as tablets for oral administration with 240ml of room temperature water. Standardized meals will be provided while participants are in the Clinical Research Unit per Clinical Research Unit Standard Operating Procedure. Treatment 2: Single 500 mg dose of SCY-770 administered 15 minutes prior to the start of a standardized breakfast, which should be consumed within 30 minutes. Treatment 3: Single 500 mg dose of SCY-770 administered 30 minutes after the start of a standardized breakfast, which should be consumed within 30 minutes. Cohort 1 is an open-label, randomized cross-over study in 9 participants to understand how food affects the absorption of SCY-770 and to determine the best dosing conditions. Each participant will receive three single-dose treatments (500 mg) under different food conditions, with a 4-day gap between doses. Based on the results from Cohort 1, the Sponsor will decide the dosing instructions for the next cohorts without changing the protocol. Breakfast Example: 3 slices of wholewheat bread/toast with 20 g spread and 30 g jam, 20 g cheese, 15 g bacon, and 1–2 cups decaffeinated tea or coffee (maximum two cups of both).
Sponsors
SCYNEXIS, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
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, heart tracing (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 be allowed 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 eating standardized 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 28 days 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 or complete the study, they will not be included. - If a person has any past illness or medical condition that could affect the study results or make participation 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 be included. - 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 study doctor believes it is still safe. - People with heart rhythm issues (such as prolonged QT interval [QT interval = time taken for the heart to beat and prepare for the next beat.]) or conditions that may increase the risk of serious irregular heartbeat will not be included. - People with a family history of certain heart rhythm disorders (like Long QT Syndrome = Long QT Syndrome = 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 and during the study will not be included. Some simple medications like paracetamol or vitamins may be allowed 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 (like kidney 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 cervical conditions that were successfully treated many years ago. - People with liver disease or abnormal liver test results may not be included, unless repeat tests are acceptable 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