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NCT06808932 · ClinicalTrials.gov registry record · Phase 1
VK4-116 Phase I Study With Food-Effect
A Phase 1 study, sponsored by National Institute on Drug Abuse (NIDA).
- Not yet
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT06808932: Clinical Trial Phase 1 study, sponsored by National Institute on Drug Abuse (NIDA).
NCT06808932 is a Phase 1 study that has not yet begun recruiting, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06808932, a Phase 1 study, has not yet begun recruiting, sponsored by National Institute on Drug Abuse (NIDA).
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study 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.
Primary Outcome
The number of treatment-emergent adverse events will be measured using a combination of data collection methods, including tracking adverse events and assessing their onset or worsening relative to the initiation of treatment. The most recent version of the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms will be used to classify adverse events, including their relationship to the treatment and maximum severity. Events will be identified either through subject self-report or
Interventions
- DRUG Placebo
- DRUG VK4-116
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2026-08-01 |
| Est. Completion | 2027-08-30 |
| Phase | Phase 1 |
What is known before NCT06808932 opens enrollment
NCT06808932 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06808932 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06808932 about?
NCT06808932 is a clinical study titled "VK4-116 Phase I Study With Food-Effect". 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.
What is the current status of trial NCT06808932?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2026-08-01. Estimated completion is 2027-08-30.
What interventions are being tested in trial NCT06808932?
The interventions under investigation include: Placebo (DRUG), VK4-116 (DRUG).
Who is sponsoring clinical trial NCT06808932?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06808932's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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