Printed from Voxsanity (voxsanity.com.au) — NCT07457190 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 1 Depression and Anxiety Trial, Not Yet Recruiting
NCT07457190
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who are willing to voluntarily sign a consent form before the trial begins, understand what the trial involves, and agree to follow the trial procedures throughout.
- People (and their partners) who are willing to avoid pregnancy from the screening stage until at least 6 months after the last dose of the study drug, and who agree to use highly effective contraception during this time.
- People aged between 18 and 70 years old (inclusive), of any gender.
- Male participants who weigh at least 50 kg, and female participants who weigh at least 45 kg, with a Body Mass Index (BMI) between 18 and 32 kg/m² (inclusive) — BMI is a measure calculated from height and weight.
- People whose kidneys are filtering at a rate of at least 60 mL/min, as measured by a creatinine clearance test.
- People with normal liver function who are matched to the liver impairment group in terms of weight (within ±10 kg), age (within ±10 years), and gender balance (within ±1 person per gender).
- People with liver impairment who have chronic liver damage caused by a primary liver disease, are classified as Child-Pugh A or B (a measure of liver disease severity), have a confirmed diagnosis of cirrhosis (scarring of the liver), and have either been on a stable medication plan for at least 14 days before taking the study drug without needing any dose changes, or have not been taking any medication.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have a history of severe drug allergies or hypersensitivity reactions, or who are known to be allergic to the study drug or any of its ingredients.
- People whose heart electrical activity test (electrocardiogram) during screening shows a QTc interval above 470 milliseconds (for males) or above 480 milliseconds (for females) — this is a measurement of heart rhythm timing.
- People who have difficulty swallowing or any digestive system condition that could affect how the body absorbs a drug, including frequent nausea or vomiting for any reason.
- People who have an active infection requiring treatment (such as bacterial, viral, parasitic, or fungal — not including hepatitis B or C) during the screening period, or who have had a serious active infection within 1 month before screening.
- People who have had major surgery in the previous 6 months (such as surgery involving the brain, chest, abdomen, pelvis, or major limb joints, including organ transplants, heart surgery, or joint replacement), or who plan to have surgery during the study; people with a history of liver transplantation; people who have previously had surgery that may affect how the body processes drugs (such as removal of part of the stomach or small intestine), or who may need to be hospitalised during the trial period.
- People who have received a vaccine in the 14 days before screening, or who plan to receive a vaccine during the study period.
- People who have donated blood or lost 200 mL or more of blood in the 3 months before screening, or who plan to donate blood during the trial or within 1 month after it ends.
- People who have taken another clinical trial drug in the 3 months before screening, or who plan to participate in another clinical trial during the study period.
- People who have used certain medications that strongly affect how the liver or kidneys process drugs (specifically strong or moderate inducers or inhibitors of CYP2B6, CYP3A4, or renal transporter inhibitors) within 1 month before screening, or within 5 times the half-life of the medication — whichever is the longer period (confirm with trial site).
- People who have consumed grapefruit or grapefruit products, or food and drinks containing caffeine, xanthine, or alcohol (such as chocolate, tea, coffee, or cola) in the 48 hours before taking the study drug; or people who engage in intense exercise or have other factors that could affect how the body processes drugs.
- People who, in the 3 months before screening, regularly drank more than 14 units of alcohol per week (where 1 unit equals 360 mL of beer, 45 mL of spirits at 40% alcohol, or 150 mL of wine), or who return a positive alcohol test during screening; or people who smoked an average of 10 or more cigarettes per day in the 3 months before screening.
- People who have a history of drug use or drug abuse, or who return a positive drug screening result.
- Women who are pregnant or breastfeeding, or women of childbearing age who test positive for pregnancy.
- People who cannot tolerate blood draws by needle, or who have a history of fainting at the sight of needles or blood.
- People who the research team considers unsuitable for the trial for other reasons.
- People with normal liver function who have any history of liver impairment.
- People with normal liver function who have previously had or currently have any clinically serious disease, including conditions affecting the heart and circulation, hormones, nervous system, digestion, breathing, blood, immune system, mental health, or metabolism, or any other condition that could interfere with trial results.
- People with normal liver function whose physical examination, vital signs, blood tests, 12-lead electrocardiogram, abdominal ultrasound, or other test results are considered clinically significant by the researchers.
- People with normal liver function who test positive for hepatitis B surface antigen, hepatitis C antibody, HIV antigen/antibody, or syphilis antibody.
- People with normal liver function who have used any prescription medicines, over-the-counter medicines, herbal medicines, or supplements within 14 days before receiving the study drug.
- People with liver impairment who have acute (sudden-onset) liver damage from any cause; a history of liver transplantation; or cirrhosis with serious complications including but not limited to liver failure, hepatic encephalopathy (brain problems caused by liver disease), hepatocellular carcinoma in certain stages (except those who have had curative treatment with no relapse, or those at the earliest stage of liver cancer known as BCLC stage 0); or who have experienced bleeding from swollen veins in the oesophagus or stomach within 3 months before screening.
- People with liver impairment whose screening blood test results show any of the following: liver enzyme levels (ALT or AST) more than 10 times the upper limit of normal; abnormally low white blood cell count (NE# below 0.75×10⁹/L); very low haemoglobin (HGB below 60 g/L); elevated tumour marker AFP above 100 ng/mL; very low platelet count (below 40×10⁹/L); or any other abnormal result considered clinically significant by the researchers.
- People with liver impairment who test positive for HIV antigen/antibody; or who test positive for syphilis antibodies and also test positive on a follow-up RPR (rapid plasma reagin) blood test.
- People with liver impairment who have, or have previously had, other serious diseases affecting major organ systems — including but not limited to the digestive system, lungs, kidneys, nervous system, blood, hormones, immune system, mental health, heart, or tumours — or who have clinically significant abnormalities on physical examination or chest X-ray, and who have been assessed by the research doctor as unsuitable for the trial.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Contact this trial
Principal Investigator: Hong Zhang, The First Hospital of Jilin University
Phone: 86+18911123155
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 1
Sponsor
Beijing Union Pharmaceutical Factory Ltd
Registry
ClinicalTrials.gov
Start date
1 March 2026
Est. completion
1 August 2026
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Pharmacokinetics of Buagafuran(Cmax); Pharmacokinetics of Buagafuran(AUC0-t); Pharmacokinetics of Buagafuran(AUC0-inf)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.