VK4-116 Phase I Study With Food-Effect (NCT06808932) | Clinical Trial Compass
Not Yet RecruitingPhase 1
VK4-116 Phase I Study With Food-Effect
United States48 participantsStarted 2026-08-01
Plain-language summary
This first-in-human, randomized, double-blind, placebo-controlled, single ascending dose (SAD), phase I study is designed to assess the safety, tolerability and pharmacokinetics of VK4-116 in healthy volunteers in fasted and fed state.
Who can participate
Age range
18 Years – 60 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
. Be a healthy male or female volunteer between 18 and 60 years of age, inclusive, at the time of consent.
. Have a body mass index (BMI) within a range of 17.0 to 36.0 kg/m2 and a minimum weight of at least 50.0 kg at screening.
. Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.
. Have no clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG.
. A female study participant must meet one of the following criteria:
. Be able and willing to comply with protocol requirements and the rules and regulations of the study site, and be likely to complete all the study treatments.
Exclusion criteria
. Have any clinically significant finding within one year of Screening on medical history, physical examination, complete neurological examination, clinical laboratory test, vital signs or ECGs that contraindicate participation in the study. This includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, gastrointestinal (GI), pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy.
. Use nicotine products via smoking/vaping in past 6 months.
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 Treatment-Emergent Adverse Events in Healthy Adult Participants
Timeframe: 7 days for fasted condition, 11 days for fed condition
. Have a sitting systolic blood pressure (BP) \>140 mmHg, diastolic BP \>90 mmHg and heart rate (HR) \<45 or \>100 beats per minute (BPM) at screening and clinic intake.
. History of unstable angina; a history of myocardial infarction; or a history of a clinically significant cardiac arrhythmia,
. Has a QT interval corrected for heart rate using Fredericia formula \>450 milliseconds in males or \>470 milliseconds in females, or evidence of left bundle branch blocks (Note: right bundle branch block is acceptable), second or third degree AV block, or evidence of left ventricular hypertrophy on ECG
. Have a history of liver disease or current elevation of aspartate aminotransferase (AST), alanine aminotransferase (ALT), 2 × the upper limit of normal (ULN).
. Have a history of renal disease or current renal function test values as follows:
. Have donated blood (excluding plasma donation) of approximately 500 mL within 56 days prior to screening.