National Institute on Drug Abuse (NIDA)
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.
Approximately 48 healthy volunteers will be enrolled and randomized to receive either VK4-116 or a placebo within one of five ascending dose cohorts. Each cohort will consist of eight participants, with a 6:2 ratio of active drug to placebo assignment. Dose escalation decisions will be made following a review of blinded safety, tolerability, and pharmacokinetic (PK) data from the preceding cohort. The proposed dose levels under fasting conditions are 50 mg, 100 mg, 200 mg, 400 mg, and 500 mg. Additional cohort will receive a 200 mg dose in a fed state, approximately 30 minutes after a high-fa…
Inclusion Criteria: 1. Be a healthy male or female volunteer between 18 and 60 years of age, inclusive, at the time of consent. • The masculine / feminine gender is used without any discrimination and with the aim to lighten the text. 2. 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. 3. Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures. 4. Have no clinically significant concurrent medical conditions determined by medic…
D3R antagonist
Each of the four dose groups of n=8 participants will be assigned to active drug or placebo in the ration 6:2.
Arctuva estimate
Verify or correct the compensation shown for this listing.