Status and phase
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About
This is a randomized, double-blind, placebo-controlled phase I study to evaluate the safety, tolerability and PK profiles of orally administered VG290131 in healthy subjects. The main questions it aims to answer are:
Approximately 86 subjects will be enrolled in the study.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
A subject will be eligible for inclusion in this study only if all of the following criteria are met:
Willing to comply with protocol required visit schedule and visit requirements and provide written ICF;
Healthy adult male and female subjects, aged 18 to 45 years of age (inclusive) at the time of signing the ICF;
Body mass index between 18.0 and 32.0 kg/m2, inclusive;
Considered medically healthy as determined by the investigator, based on medical history and clinical evaluations including physical examination, clinical laboratory tests, vital sign measurements, and 12-Lead ECG;
Male subjects must agree to practice true abstinence; be surgically sterilized (performed at least 6 months prior to screening and documented to no longer produce sperm - verbal confirmation through medical history review acceptable); or agree to use a condom plus effective contraception methods for their female partner, if of childbearing potential, from the signing of ICF to 3 months after the last dose of IMPs and refrain from donating sperm during this period. These contraception requirements do not apply if the male subject is in an exclusively same sex relationship;
Female subjects are eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
Exclusion criteria
A subject meeting any of the following exclusion criteria will not be allowed to participate in this study:
Ascertained or presumptive hypersensitivity (including allergies) to any ingredient of the VG290131; history of other significant allergies or anaphylaxis, as determined by the investigator;
Considered by the investigator to be ineligible for the study due to a history of or current condition of significant metabolic or endocrine, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, immunological, neurological, or psychiatric disorders with clinical manifestations;
Active or history of serious mental illness or psychiatric disorder, including but not limited to schizophrenia, bipolar disorder, or severe depression, which require current pharmacological intervention;
History of stomach or intestinal surgery or resection diseases including but not limited to, gastric band/gastric resection and/or intestinal resection and/or duodenal disease (i.e. celiac disease) which may potentially alter absorption and/or excretion of VG290131 (except for an appendectomy);
Used drugs or substances known to be inducers or inhibitors of cytochrome P450 enzymes or P-glycoprotein (P-gp) substrates within 28 days or 5 half-lives (whichever is longer) prior to the first dose of IMPs;
Used prescription or over-the-counter (OTC) drugs (with the exception of hormonal contraception, menopausal hormone replacement therapy or occasional analgesics such as Paracetamol [1 g per dose and maximum 2-4 g per day], Ibuprofen and standard daily vitamins etc. in short term at the Investigator's discretion), within 14 days or 5 half-lives (whichever is longer) prior to the first dose of IMPs;
Participated in any other investigational trials or has been exposed to other investigational drugs within 28 days or 5 half-lives of the previously administered investigational drug, whichever is longer, prior to the first dose of IMPs;
Smoking ≥ 5 cigarettes per day (or an equivalent amount of any other nicotine-containing products) within 6 months before screening or unable to stop smoking during the study;
Alcohol consumption of > 21 units per week for males and > 14 units per week for females within the 6 months before screening (1 unit=360 mL of beer or 45 mL of spirits with an alcohol content of ≥ 40% or 150 mL of wine) or a positive result of alcohol breath test on admission or unable to abstain from consuming alcohol from 24 h prior to admission, until completion of the end of study (EOS) visit;
History of drug abuse within the 12 months before screening or a positive result of drug abuse test at screening;
Consumption of any nutrients known to modulate cytochrome P450 enzymes or P-gp substrates activity (eg, grapefruit, pomelo, mango, star fruit, Seville [blood] orange products, caffeine or xanthine-containing food or beverages) within 72 h before the first dose of IMPs;
Clinically significant laboratory abnormalities, as determined by the Investigator, including but not limited to (If the results are beyond the normal range or significantly changed, the investigator deems it necessary to repeat the measurement, vital signs and 12-Lead ECG may be repeated twice, clinical laboratory tests [hematology, urinalysis, biochemistry and coagulation function test] may be repeated once):
Known active infections, e.g., bacterial, fungal and viral infections, including:
Has donated blood or plasma within 30 days prior to screening or had a loss of whole blood of more than 500 mL within the 30 days prior to screening, or receipt of a blood transfusion within one year prior to screening;
The subject has difficulty in swallowing oral medications;
Inability to be venipunctured and/or tolerate venous access; Any conditions which would make the subject unsuitable for enrollment or could interfere with the subject's participation in or completion of the study in the opinion of the investigator.
Primary purpose
Allocation
Interventional model
Masking
86 participants in 10 patient groups
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Central trial contact
Dr. Ana Liza Sun
Data sourced from clinicaltrials.gov
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