A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 as Well as the Impact of AZD4144 on the Pharmacokinetics of Rosuvastatin in Healthy Participants
NCT Number: NCT06491550
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Participants
Interventions: DRUG: AZD4144- Part A|DRUG: Placebo- Part A|DRUG: AZD4144- Part B|DRUG: Placebo- Part B|DRUG: Rosuvastatin- Part C|DRUG: Rosuvastatin and AZD4144 Part C
Sponsor: AstraZeneca
Sex: ALL
Age: ADULT
Enrollment: 92
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2025-04-10
Locations: Research Site, Glendale, California, 91206, United States|Research Site, Brooklyn, Maryland, 21225, United States

Summary:
This study consists of 3 parts; Part A, Part B and Part C. This study will compare the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD4144 with placebo in healthy participants, in Part A and Part B. Part C of this study will investigate the possibility of drug-drug interaction (DDI) between IV AZD4144 and oral rosuvastatin by evaluating the PK of rosuvastatin when administered alone and in combination with single IV dose of AZD4144.

Primary Outcome Measures: Number of participants with adverse events (AEs) (Part A and Part B), To assess the safety and tolerability of AZD4144 following IV administration of single (Part A) and multiple (Part B) ascending doses in healthy participants., Part A: Day 1 to Day 10+3; Part B: Day 1 to Day 20+3.|Area under plasma concentration-time curve from time 0 to infinity (AUCinf) (Part C), To evaluate the effect of AZD4144 on the PK of rosuvastatin in healthy participants., Treatment period 1: Day 1 to 3; Treatment period 2: Day 10 to 12.|Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) (Part C), To evaluate the effect of AZD4144 on the PK of rosuvastatin in healthy participants., Treatment period 1: Day 1 to 3; Treatment period 2: Day 10 to 12.|Maximum observed drug concentration (Cmax) (Part C), To evaluate the effect of AZD4144 on the PK of rosuvastatin in healthy participants., Treatment period 1: Day 1 to 3; Treatment period 2: Day 10 to 12.
Secondary Outcome Measures: Cmax (Part A and Part B), To characterize the PK of AZD4144 following IV administration of single (Part A) and multiple (Part B) ascending doses., Part A: Day 1 to Day 10+3; Part B: Day 1 to Day 20+3|AUClast (Part A and Part B), To characterize the PK of AZD4144 following IV administration of single (Part A) and multiple (Part B) ascending doses, Part A: Day 1 to Day 10+3; Part B: Day 1 to Day 20+3|AUCinf (Part A), To characterize the PK of AZD4144 following IV administration of single (Part A) ascending doses., Part A: Day 1 to Day 10+3|Area under concentration-time curve in the dosing interval (AUCτ) (Part B only), To characterize the PK of AZD4144 following IV administration of multiple (Part B) ascending doses, Part B: Day 1 to Day 20+3|Renal clearance of drug from plasma (CLR) (Part A and Part B), To characterize the PK of AZD4144 following IV administration of single (Part A) and multiple (Part B) ascending doses., Part A: Day 1 to 3; Part B: Day 1, 12 and 20+3|PD analysis: Levels of disease-specific biomarkers (Part A and Part B), To assess the effect of AZD4144 on levels of disease-specific biomarkers. (Part A and Part B), Part A: Day -1 to 4; Part B: Day -1 to Day 1, Day 12 to Day 15|Number of participants with adverse events (AEs) (Part C), To assess the safety and tolerability of AZD4144 in combination with rosuvastatin in healthy participants., Part C: Day 1 to Day 20+3