A Study to Investigate the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants with Renal Impairment

Start 18 Nov 2024 · End 20 Mar 2025 · Status Ended · 1 EU/EEA countries · 2 sites · Protocol D9090C00010

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ended

Participants planned 32

Countries 1

Sites 2

Impaired renal function

Key facts

Sponsor: AstraZeneca AB
Participant type: Healthy volunteers, Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12], Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
Trial duration: 18 Nov 2024 → 20 Mar 2025
Decision date (initial): 2024-10-28
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Impaired renal function

Version	Level	Code	Term	System organ class
20.0	SOC	10038359	Renal and urinary disorders	18
22.1	LLT	10009122	Chronic renal impairment	10038359

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation: AstraZeneca AB
Address: -
City: Sodertalje
Postcode: 151 85
Country: Sweden

Scientific contact point

Organisation: AstraZeneca AB
Contact name: AstraZeneca Clinical Study Information Centre

Public contact point

Organisation: AstraZeneca AB
Contact name: AstraZeneca Clinical Study Information Centre

Locations

1 EU/EEA country · 2 investigational sites

By country

Country	MS status	Planned subjects	Sites
Bulgaria	Ended	32	2
Rest of world	—	0	—

Investigational sites

Bulgaria

2 sites · Ended

Medical Center Comac Medical Ltd.

0901:NA, Ulitsa Sveti Georgi Sofiyski 3, 1606, Sofia