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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

NCT06491550 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2025-07-04

No results posted yet for this study

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

Conditions

  • Healthy Participants

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-15
Primary Completion
2025-06-11
Completion
2025-06-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06491550 on ClinicalTrials.gov