Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000754347
Ethics application status
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Approved
Date submitted
Help: Date submitted
21/05/2026
Date registered
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25/06/2026
Date last updated
Help: Date last updated
25/06/2026
Date data sharing statement initially provided
Help: Data sharing statement date
25/06/2026
Type of registration
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Retrospectively registered

Titles & IDs
Public title
Open-label, randomized, cross-over, 3-period study to assess the effect of food on the absorption of oral SCY-770 in healthy volunteers" (Cohort 1)
Scientific title
Open-label, randomized, cross-over, 3-period study to assess the effect of food on the absorption of oral SCY-770 in healthy volunteers
Additional trial identifiers [1] 317328 0
SCY-770-101
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Non-Alcoholic Fatty Liver Disease [NAFLD] 341977 0
Condition category
Condition code
Metabolic and Endocrine 338059 338059 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
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).
Intervention code [1] 334116 0
Treatment: Drugs
Description of the comparator or control
Treatment 1: Single 500 mg dose of SCY-770 administered under fasted conditions, following an overnight fast of at least 10 hours; water consumption allowed until 1 hour prior to dose administration
Control group
Active

Outcomes
Primary outcome [1] 345468 0
Safety and tolerability will be assessed as a Composite outcome and evaluated through monitoring of adverse events (AEs), vital signs, serial ECGs, and clinical laboratory assessments (blood and urine), along with physical examinations
Timepoint [1] 345468 0
Cohort 1: - 12 Lead ECG: at screening; Day -1; Days 1, 5 and 9: predose, and then at 2, 4, 8, 12 and 24 hours postdose; and at Post study visit/End of Treatment - Vital SIgns: at screening; Day -1; Days 1, 5 and 9 before dose and then at 1, 2, 4, 8, 12 and 24 hours postdose; On all non-dosing days prior to morning PK sampling, and at Post study visit. - Laboratory safety tests: coagulation (screening only); hematology, clinical chemistry, urinalysis on Screening & Day-1. - Physical Examination: Symptom directed physical examination (Day -2/-1 and Predose)- - Adverse Event: Adverse events and concomitant medication will be collected from the time of informed consent, Screening, Day-1. predose, Day 1, day2, day3, day4, day5, day6, day7, day7, day8, day9, day10, day11, day12, day13, day25 through the Post study visit/End of treatment.
Secondary outcome [1] 461794 0
To evaluate the effect of a standard meal on the plasma pharmacokinetics of SCY-770 following a single oral dose in healthy participants.
Timepoint [1] 461794 0
Cohort 1: Blood PK sampling: Day 1 predose and at 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, 48 and 72 hours postdose; Day 5: predose and at 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, 48 and 72 hours postdose; Days 9: predose and at 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, 48, 72 and 96 hours postdose

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Healthy volunteers
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Cohort 1 will be randomized and crossover and enrolled (Randomization will be according to a computer-generated randomization schedule)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated to treatment groups based on a computer-generated randomization schedule—receiving a specific treatment sequence in Cohort 1
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/06/2026
Date of last participant enrolment
Anticipated
25/06/2026
Actual
Date of last data collection
Anticipated
20/07/2026
Actual
Sample size
Target
9
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 321894 0
Commercial sector/Industry
Name [1] 321894 0
SCYNEXIS, Inc.
Country [1] 321894 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
SCYNEXIS, Inc.
Address
Country
Australia
Secondary sponsor category [1] 324757 0
Commercial sector/Industry
Name [1] 324757 0
Novotech (Australia) Pty Limited
Address [1] 324757 0
Country [1] 324757 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320435 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 320435 0
Ethics committee country [1] 320435 0
Australia
Date submitted for ethics approval [1] 320435 0
06/05/2026
Approval date [1] 320435 0
04/06/2026
Ethics approval number [1] 320435 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 150470 0
Dr Christopher Argent
Address 150470 0
Scientia Clinical Research Bright Building, Level 5, Corner High & Avoca Street, Randwick NSW 2031, Australia
Country 150470 0
Australia
Phone 150470 0
+61 0458639115
Fax 150470 0
Email 150470 0
[email protected]
Contact person for public queries
Name 150471 0
Misha Binder
Address 150471 0
Scynexis Inc, 1 Evertrust Plaza, Jersey City, NJ 07302
Country 150471 0
United States of America
Phone 150471 0
+1 732 766 0074
Fax 150471 0
Email 150471 0
[email protected]
Contact person for scientific queries
Name 150472 0
Christopher Argent
Address 150472 0
Scientia Clinical Research Bright Building, Level 5, Corner High & Avoca Street, Randwick NSW 2031, Australia
Country 150472 0
Australia
Phone 150472 0
+61 0458639115
Fax 150472 0
Email 150472 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.