None listed
Conditions
Brief summary
Approximately 12 healthy participants will take part in this study to compare how the body absorbs GV-100 when taken with food and without food. Each participant will receive the study drug under both conditions, with a 7-day break between doses. Participants will undergo screening, stay at the study center during dosing visits for monitoring, and attend a follow-up visit after completing the study. The study will only begin after earlier safety results have been reviewed and found acceptable.
Interventions
Part 3: Food Effect (FE)
Participants will be administered one selected dose of GV-100 on Day 1 (treatment period 1) and on Day 8 (treatment period 2) under fasted and fed conditions in a 2-way crossover, according to one of the treatment sequences. The planned dose of GV-100 for part 3 FE is 400 mg (the final dose will be selected based on the data from the preceding cohorts).
The Food Effect part will assess the effect of food on the Pharmacokinetic (PK) of GV-100 and may be initiated afte
Part 3: Food Effect (FE) Participants will be administered one selected dose of GV-100 on Day 1 (treatment period 1) and on Day 8 (treatment period 2) under fasted and fed conditions in a 2-way crossover, according to one of the treatment sequences. The planned dose of GV-100 for part 3 FE is 400 mg (the final dose will be selected based on the data from the preceding cohorts). The Food Effect part will assess the effect of food on the Pharmacokinetic (PK) of GV-100 and may be initiated after Safety Review Committee (SRC) approval of safety and Pharmacokinetic (PK) data from a single ascending dose (SAD) dose level higher than the planned Food Effect dose. The planned dose is 400 milligrams, with the final dose selected based on emerging single ascending dose (SAD) data and below the highest acceptable Single Ascending Dose (SAD). Approximately 12 participants will be enrolled in a randomized, 2-way crossover design, receiving GV-100 under fasted and fed conditions in alternate periods. Participants will be screened between Day -28 and Day -2. For Treatment Period 1, participants will be admitted on Day -1, dosed on Day 1, and confined through Day 2. After a minimum 7-day washout, Treatment Period 2 will follow with dosing on Day 8 and confinement through Day 9. A follow-up visit will occur on Day 15 (±1 day). A mouth check will be performed following administration to confirm complete consumption of the IP while inpatient admission. Fastened Condition (Control): 10hours of fasting before Dosing until after dosing 4hours. No fluids will be allowed from 1 hour before dosing until 1 hour after dosing. Water will be permitted ad libitum at all other times. Fed Condition: Supervised Fast of 10hours, High fat high calorie meal will be served with 800-1000 Calories (approximately 50% of total caloric content of the meal derived from fat) of food which will be derived with 150, 250 & 500-600 Calories from Protein, Carbohydrate and fat respectively. No Fluids allowed before and after 1 Hour of Dosing.
Sponsors
Gilva Therapeutics, INC.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
- Male or female participants, aged more than or equal 18 to less than or equal to 65 years at the time ofproviding informed consent, who are non-smokers (no use of tobacco or nicotine-containing productswithin 3 months prior to screening), with a body mass index (BMI) greater than 18.0 and less than 32.0kilogram/meter square, and a minimum body weight of 50.0 kilogram. - Healthy individuals, as determined by the Principal Investigator or delegate, defined as: a. No clinically significant illness or surgical procedures within 4 weeks prior to study drug administration. b. No clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, or metabolic disorders. - Capable of understanding the study procedures and willing to provide written informed consent prior toparticipation.
Exclusion criteria
- Any clinically significant abnormal finding on physical examination, as determined by the Principal Investigator or delegate. - Clinically significant abnormal laboratory results at screening, in the opinion of the Principal Investigator or delegate. - Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and/or total bilirubin levels greater than 1.5 and upper limit of normal (ULN) at screening. - Estimated glomerular filtration rate (eGFR) Less than or equal 90 milliliter/minute/1.73 meter square at screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. - Positive test results at screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen or antibody. Participants with a positive hepatitis B surface antibody (HBsAb) due to prior vaccination are permitted. - Any current active infection, including localized infections, or a recent history (within 1 week prior to dosing) of infection, cough, or fever, or a history of recurrent or chronic infections. - Any disease or history of surgery that, in the opinion of the Principal Investigator or delegate, could significantly affect the absorption, distribution, metabolism, or excretion of the investigational product. - Positive pregnancy test or lactation in female participants. - Positive urine drug screen, urine cotinine test, or alcohol breath test. - History of clinically significant allergic reactions, including anaphylaxis, hypersensitivity, or angioedema, to any medication, or known allergy to GV-100, related compounds, or any formulation excipients. - Clinically significant abnormalities in Electrocardiogram (ECG) findings or vital signs at screening, as determined by the Principal Investigator or delegate. - Supine systolic blood pressure greater than or equal to 160 mmHg or diastolic blood pressure greater than or equal to 95 millimeters of mercury. (mmHg) at screening after at least 5 minutes of rest. If elevated, blood pressure will be repeated two additional times, and the average of three measurements will be used to assess eligibility. - History of drug abuse within 6 months prior to first dosing, or substance abuse considered clinically significant by the Principal Investigator or delegate. - History of alcohol abuse within 6 months prior to first dosing, defined as consumption exceeding 21 units per week for males or 14 units per week for females (1 unit equals 240 milliliter beer, 120 milliliter wine, or 30 milliliter distilled Alcohol). - Use of depot injections or implants within 3 months prior to first dosing. - Receipt of live or live-attenuated vaccines (bacterial or viral) within 12 weeks prior to screening, or planned receipt during the study period. - Receipt of any vaccine, including COVID-19 vaccines, within 14 days prior to first dosing. - Use of any drug known to induce or inhibit hepatic drug-metabolizing enzymes within 30 days or 5 half-lives (whichever is longer) prior to first dosing. - Use of prescription medications within 14 days or 5 half-lives (whichever is longer) prior to first dosing. - Use of over-the-counter medications or natural health products, including herbal remedies (e.g., St. John’s wort), traditional medicines, probiotics, dietary supplements, or sports supplements within 14 days or 5 half-lives (whichever is longer) prior to first dosing, except for occasional paracetamol up to 2grams/day. - Participation in another clinical research study involving an investigational or marketed drug or devicewithin 30 days or 5 half-lives (whichever is longer) prior to first dosing; participation involving a biologicalproduct within 90 days prior to dosing; or concurrent participation in any investigational study without drugor device administration. - Donation of plasma or platelets within 14 days prior to dosing, or donation or loss of equals 500 milliliterof whole blood within 60 days prior to dosing. - Previous exposure to GV-100. - Any other condition or circumstance that, in the opinion of the Principal Investigator or delegate, could interfere with study participation or compliance, which will be documented in the source records. - Participants unable to complete the required high-fat meal within the specified timeframe and those who follow a strict vegetarian or vegan diet will be excluded from participation.
Outcome results
None listed