NCT06491550

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 as Well as the Impact of AZD4144 on the Pharmacokinetics of Rosuvastatin and Furosemide in Healthy Participants

A Phase I Randomized, Single-blind, Placebo-controlled, and Sequential Group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 Following Single and Multiple Ascending Doses Via Intravenous Administration, and an Open-label, 2-Period, 2-Sequence, Cross-over Study to Assess the Effects of Intravenous AZD4144 on Rosuvastatin and Furosemide Pharmacokinetics in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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 and furosemide by evaluating the PK of rosuvastatin and furosemide when administered alone and in combination with single IV dose of AZD4144

Detailed description

This is a Phase I, randomized study in healthy participants and consists of 3 parts; Part A, Part B and Part C. Part A and B are single-blind, placebo-controlled with single ascending dose (SAD) and multiple ascending dose (MAD) sequential group design, respectively. Part C is an open-label, 2-period, 2-sequence, cross-over design study. Part A and B of the study will assess the safety, tolerability, PK, and PD of AZD4144 solution for infusion compared with placebo while Part C will investigate the possibility of DDI between IV AZD4144 and oral rosuvastatin and furosemide by evaluating the PK of rosuvastatin and furosemide when administered alone and in combination with single IV dose of AZD4144 The study will comprise of: * A screening period of maximum 28 days. * A residential period which lasts from, * Day -1 to Day 4 (single dose on Day 1) for Part A * Day -1 to Day 15 (dosed on days 1, 4-12) for Part B * Day -1 to Day 3 (dose on Day 1) and Day 9 to Day 12 (dose on Day 10) for Part C * A final follow-up visit, * On Day 10+3 for Part A * On Day 20+3 for Part B and C

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD4144- Part A	Part A: Participants will be administered a single dose of AZD4144 on Day 1 via Intravenous (IV) infusion.
DRUG	Placebo- Part A	Part A: Participants will be administered a single dose of placebo on Day 1 via IV infusion.
DRUG	AZD4144- Part B	Part B: Participants will be administered a single dose of AZD4144 on Day 1 and Day 12 via IV infusion. Participants will be administered multiple doses of AZD4144 from Day 4 to Day 11 via IV infusion.
DRUG	Placebo- Part B	Part B: Participants will be administered a single dose of placebo on Day 1 and Day 12via IV infusion. Participants will be administered multiple doses of placebo from Day 4 to Day 11 via IV infusion.
DRUG	Rosuvastatin and Furosemide- Part C	Participants will be administered a single oral dose of 10 mg Rosuvastatin and 1 mg Furosemide.
DRUG	Rosuvastatin, Furosemide, and AZD4144 Part C	Participants will be administered a single oral dose of 10 mg Rosuvastatin, 1 mg Furosemide and a single dose of AZD4144 via IV infusion.

Timeline

• Start date: 2024-07-15
• Primary completion: 2025-06-11
• Completion: 2025-06-11
• First posted: 2024-07-09
• Last updated: 2025-07-04

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study