Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-28 @ 1:02 PM
Study NCT ID:
NCT06808932
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-22
First Post:
2025-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VK4-116 Phase I Study With Food-Effect
Sponsor:
National Institute on Drug Abuse (NIDA)
Organization:
Study Overview
Official Title:
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study With Food-Effect Cohort to Assess the Safety, Tolerability, and Pharmacokinetics of Oral (R) VK4-116 in Healthy Volunteers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
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-fat, high-calorie breakfast. Dose adjustments may be made based on the safety, tolerability, and PK data observed in earlier cohorts.
Participants will be admitted to the research clinic one day prior to receiving their assigned treatment. Following the administration of VK4-116 or placebo, participants will be continuously monitored for adverse events, and PK blood samples will be collected at predetermined intervals. Participants will remain in the clinic for 4 days, until the 72-hour PK blood sample has been collected. Participants in the food-effect cohort will stay in the clinic for 8 days (for fasted stat followed by fed state assessments). A follow-up visit will be scheduled three days after discharge from the clinic.
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-fat, high-calorie breakfast. Dose adjustments may be made based on the safety, tolerability, and PK data observed in earlier cohorts.
Participants will be admitted to the research clinic one day prior to receiving their assigned treatment. Following the administration of VK4-116 or placebo, participants will be continuously monitored for adverse events, and PK blood samples will be collected at predetermined intervals. Participants will remain in the clinic for 4 days, until the 72-hour PK blood sample has been collected. Participants in the food-effect cohort will stay in the clinic for 8 days (for fasted stat followed by fed state assessments). A follow-up visit will be scheduled three days after discharge from the clinic.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: