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 range18 Years – 60 Years
SexALL
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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.
✕. 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.
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
✕. 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.