ADPKD (Autosomal Dominant Polycystic Kidney Disease)
Conditions
Keywords
GV-100
Brief summary
This is a first-in-human, multi-part clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), food effect, and drug-drug interaction (DDI) potential of GV-100 following oral administration in healthy participants. The study is divided into four parts: Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), Food Effect (FE), and Drug-Drug Interaction (DDI).
Interventions
DRUGGV-100
GV-100 will be administered orally
DRUGPlacebo
Matched to GV-100
Sponsors
Gilva Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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 of providing informed consent, who are non-smokers (no use of tobacco or nicotine-containing products within 3 months prior to screening), with a body mass index (BMI) greater than 18.0 and less than 32.0 kilogram/meter square, and a minimum body weight of 50.0 kilogram. * Healthy individuals, as determined by the Principal Investigator or delegate, defined as: 1. No clinically significant illness or surgical procedures within 4 weeks prior to study drug administration. 2. 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 to participation.
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 × the 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 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 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 = 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 2 grams/day. * Participation in another clinical research study involving an investigational or marketed drug or device within 30 days or 5 half-lives (whichever is longer) prior to first dosing; participation involving a biological product within 90 days prior to dosing; or concurrent participation in any investigational study without drug or device administration. * Donation of plasma or platelets within 14 days prior to dosing, or donation or loss of equals 500 milliliter of 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event | Up to 7 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration (Cmax) of GV-100 | Part 1: From Day 1 to Day 2 Part 2: From Day 1 to Day 15 Part 3: From Day 1 to Day 9 Part 4: From Day 1 to Day 15 | Plasma concentration of GV-100 |
| Area under the plasma concentration time curve (AUC) of GV-100 | Part 1: From Day 1 to Day 2 Part 2: From Day 1 to Day 15 Part 3: From Day 1 to Day 9 Part 4: From Day 1 to Day 15 | Measure of AUC |
Countries
Australia
Contacts
CONTACTI-Chu Tsai
Outcome results
None listed