VK4-116 Phase I Study With Food-Effect
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNational Institute on Drug Abuse (NIDA)
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
History of unstable angina; a history of myocardial infarction; or a history of a clinically significant cardiac arrhythmia,
Trial design
Treatments tested in this trial
- VK4-116
- Placebo
Treatment groups
48 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
National Institute on Drug Abuse (NIDA)
Lead sponsor
Altasciences Company Inc.
Collaborator
Source ClinicalTrials.gov