A Study of VRG50635 in Healthy Volunteers (NCT06286475) | Clinical Trial Compass
CompletedPhase 1
A Study of VRG50635 in Healthy Volunteers
United States22 participantsStarted 2024-02-29
Plain-language summary
The primary objectives of this study are to investigate the safety and tolerability of VRG50635 and to determine how VRG50635 is absorbed by the body.
Who can participate
Age range
19 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Must be ≥ 19 and ≤ 55 years of age at Screening.
. Must be willing and able to voluntarily give written informed consent by signing an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form prior to any study-related procedures being performed.
. Must have a body mass index ≥ 18.5 and ≤ 32 kilogram per square meter (kg/m2) and weigh ≥ 50 kg.
. Participants of childbearing potential are eligible to participate if they are not pregnant or breastfeeding and agree to use one highly effective and one barrier method of contraception, if sexually active, for the duration of the study through 90 days after the last study drug administration. Participants must not donate eggs for the duration of study through 90 days after the last dose of study drug.
. Participants capable of producing sperm must agree that they will use one barrier method of contraception and that their partners of childbearing potential will use one highly effective method of contraception for the duration of the study through 90 days after the last study drug administration. Participants must not donate sperm for the duration of study through 90 days after the last dose of study drug.
Exclusion criteria
. Have a history of clinically significant hematologic, renal, neurologic, pancreatic, gastrointestinal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, immunological, allergic disease, or other major disorders, as determined by the PI.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Adverse Events
Timeframe: Up to Day 30
2
Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUCinf)
Timeframe: Up to Day 16
3
Area Under the Concentration-time Curve from Time 0 to the Last Measurable Concentration (AUClast)
Timeframe: Up to Day 16
4
Area Under the Concentration-time Curve from Time 0 to 24 Hours Post-dose (AUC0-24)
Timeframe: Up to Day 16
5
Area Under the Concentration-time Curve Between Consecutive Doses (AUCtau)
. Have any surgical or medical condition that could possibly affect drug absorption (including inflammatory bowel disease, history of gastrectomy, cholecystectomy, or other gastrointestinal tract surgery except appendectomy).
. Have a current significant medical or psychiatric condition, as determined by the PI.
. Have a history of serious adverse reaction or serious hypersensitivity to any drug.
. Have, in the opinion of the PI, evidence of clinically significant hepatic or renal impairment including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> the upper limit of normal (ULN) or bilirubin \> 1.5 × ULN. Note: Participants with Gilbert syndrome without evidence of hepatic impairment may be enrolled.
. Have a history or presence of an abnormal electrocardiogram (ECG), including, but not limited to, complete left bundle branch block, second- or third-degree heart block, evidence of prior myocardial infarction, or any other abnormality that is clinically significant in the PI's opinion or precludes accurate interpretation and calculations of cardiac intervals (e.g., QT, QRS).
. Have clinically significant abnormalities, as assessed by the PI, in laboratory tests at the screening and admission visits. Note: Participants may be rescreened at the discretion of the PI with Sponsor approval.
. Have abnormal blood pressure: supine systolic blood pressure \< 90 or \> 140 mmHg, supine diastolic blood pressure \< 50 or \> 90 mmHg, pulse rate \< 40 or \> 100 bpm, and body temperature \< 35.4 or \> 37.8 °C (\< 96 or \> 100.3 °F) at the screening and admission visits.