A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234
ConditionHepatic Impairment
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAstraZeneca
About this trial
The purpose of this study is to examine the safety and tolerability of AZD6234 and AZD9550 in participants with hepatic impairment and participants with normal hepatic function.
Eligibility criteria
Qualifiers
Age 18-85 years at consent.
Healthy controls: Medically healthy; no clinically significant findings in history, exam, labs, vitals, or 12 lead ECG (per investigator).
Hepatic impairment: Chronic (≥6 months), stable; documented Child Pugh B (Group 2) or C (Group 1).
Stable concomitant regimen ≥2 weeks before screening (Groups 1-2).
Disqualifiers
Any clinically significant disease; Diabetes;
lab values i) ALT/AST/ALP >1.5×ULN; ii) WBC/platelets <LLN; iii) haemoglobin <11.0 g/dL (female) or <12.0 g/dL (male); aPTT or PT/INR >1.2×ULN; iv) total bilirubin >1.5×ULN (or Gilbert's);
abnormal resting vital signs i) SBP >150 or <90 mmHg, ii) DBP >95 or <50 mmHg, iii) pulse ≥100 or ≤45 bpm;
QTcF >450 ms or clinically significant ECG abnormalities;
Trial design
Treatments tested in this trial
- AZD6234
- AZD9550
Treatment groups
28 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov