Clinical trial for ADPKD (Autosomal Dominant Polycystic Kidney Disease)
Official title A Phase 1 Study of Single and Multiple Ascending Doses of GV-100
ClinicalTrials.gov ID: NCT07788014
What this study is testing
What is GV-100?
GV-100 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for adpkd (autosomal dominant polycystic kidney disease).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Healthy individuals, as determined by the Principal Investigator or delegate, defined as:
- No clinically significant illness or surgical procedures within 4 weeks prior to study drug administration.
- No clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric...
- Capable of understanding the study procedures and willing to provide written informed consent prior to participation.
You likely can't join if
- 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...
- Estimated glomerular filtration rate (eGFR) Less than or equal 90 milliliter/minute/1.73 meter square at screening, calculated using the CKD-EPI...
- Positive test results at screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody, or...
- Any current active infection, including localized infections, or a recent history (within 1 week prior to dosing) of infection, cough, or fever, or a...
See the full eligibility criteria
Who can join
- 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...
- Healthy individuals, as determined by the Principal Investigator or delegate, defined as:
- No clinically significant illness or surgical procedures within 4 weeks prior to study drug administration.
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Adelaide, South Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Adelaide, South Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.