A Study Investigating the Safety, Absorption, Elimination, and the Effect on the Immune System of ACI-19764 in Healthy Participants and in Participants With Cardiovascular Risk Factors
The main purposes of this study are: * to investigate the safety and tolerability of ACI-19764 when it is administered to healthy participants and participants with cardiovascular risk factors * to determine how quickly and to what extent ACI-19764 is absorbed, transported, metabolized, and excreted by the body (fasted and after a meal) * to determine the effect of ACI-19764 on specific markers in the blood that are part of the immune system The effects of ACI-19764 will be compared with the effects of a…
Conditions studied
Healthy Participants, Obesity, Type 2 Diabetes Mellitus (T2DM)
About this study
The main purposes of this study are: * to investigate the safety and tolerability of ACI-19764 when it is administered to healthy participants and participants with cardiovascular risk factors * to determine how quickly and to what extent ACI-19764 is absorbed, transported, metabolized, and excreted by the body (fasted and after a meal) * to determine the effect of ACI-19764 on specific markers in the blood that are part of the immune system The effects of ACI-19764 will be compared with the effects of a placebo. ACI-19764 is a brain-penetrant NLRP3 inhibitor. The study consists of 3 parts, Part A (SAD, single ascending dose) and Part B (MAD, multiple ascending doses) in healthy participants, and Part C (one multiple-dose level) in participants with cardiovascular risk factors. Participants in Part A will receive the study compound once, and participants in Part B and Part C will receive the study compound multiple times (daily over 14 and 28 days, respectively). Parts A and B will be divided into different groups of participants to test different doses of ACI-19764.
Interventions
- Drug: Placebo — Placebo capsules matching ACI-19764 capsules
- Drug: ACI-19764 at dose A1 — ACI-19764 capsules at dose A1
- Drug: ACI-19764 at dose A2 — ACI-19764 capsules at dose A2
- Drug: ACI-19764 at dose A3 — ACI-19764 capsules at dose A3
- Drug: ACI-19764 at dose A4 — ACI-19764 capsules at dose A4
- Drug: ACI-19764 at dose A5 — ACI-19764 capsules at dose A5
- Drug: ACI-19764 at dose A6 — ACI-19764 capsules at dose A6
- Drug: ACI-19764 at dose B1 — ACI-19764 capsules at dose B1
- Drug: ACI-19764 at dose B2 — ACI-19764 capsules at dose B2
- Drug: ACI-19764 at dose B3 — ACI-19764 capsules at dose B3
- Drug: ACI-19764 at dose C1 — ACI-19764 capsules at dose C1
Primary outcomes
- Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, unlikely related, possibly related or probably related) (From first study treatment administration up to the end of the safety follow-up (i.e. 21 to 24 days after Day 4 for study Part A, 21 to 24 days after Day 17 for study Part B, and 21 to 24 days after Day 29 for study Part C))
- Vital signs: Change from baseline in blood pressure (From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29))
- Vital signs: Change from baseline in respiratory rate (From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29))
- Vital signs: Change from baseline in pulse rate (From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29))
- Vital signs: Change from baseline in body temperature (From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29))
- ECG: Change from baseline in heart rate (From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29))
- ECG: Change from baseline in PR interval (From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29))
- ECG: Change from baseline in QRS interval (From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29))
Eligibility information
Study locations
- ICON, Groningen, 9728 NZ Netherlands
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.