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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
AZD6234
DrugSingle subcutaneous dose of AZD6234 in participants from all groups
AZD9550
DrugSingle subcutaneous dose of AZD9550 in participants from all groups
Treatment groups
28 Participants
are divided into 3 treatment groupsGroup A: Group 1Experimental treatment 2 interventions
Group B: Group 2Experimental treatment 2 interventions
Group C: Group 3Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
PK parameters AUCinf
To compare the plasma PK of separate single SC doses of AZD9550 and AZD6234 in participants with severe and moderate hepatic impairment with matched controls with normal hepatic function
Time frame
Day 0 through Day 562
PK parameters AUClast
To compare the plasma PK of separate single SC doses of AZD9550 and AZD6234 in participants with severe and moderate hepatic impairment with matched controls with normal hepatic function
Time frame
Day 0 through Day 563
PK parameters Cmax
To compare the plasma PK of separate single SC doses of AZD9550 and AZD6234 in participants with severe and moderate hepatic impairment with matched controls with normal hepatic function
Time frame
Day 0 through Day 56Secondary outcomes
1
PK parameters tmax
To evaluate the plasma PK of separate single SC doses of AZD9550 and AZD6234 in participants with severe and moderate hepatic impairment and matched controls with normal hepatic function
Time frame
Day 0 through Day 562
Prevalence and incidence of ADAs to AZD9550 and AZD6234
To evaluate the immunogenicity of AZD9550 and AZD6234 following separate single SC doses of AZD9550 and AZD6234
Time frame
Day 0 through Day 563
PK parameters t1/2λz
To evaluate the plasma PK of separate single SC doses of AZD9550 and AZD6234 in participants with severe and moderate hepatic impairment and matched controls with normal hepatic function
Time frame
Day 0 through Day 564
PK parameters CL/F
To evaluate the plasma PK of separate single SC doses of AZD9550 and AZD6234 in participants with severe and moderate hepatic impairment and matched controls with normal hepatic function
Time frame
Day 0 through Day 56Other outcomes
1
Incidence of AEs, SAEs
To assess the safety and tolerability of separate single SC doses of AZD9550 and AZD6234 in participants with severe and moderate hepatic impairment and matched controls with normal hepatic function
Time frame
Screening through Day 56Sponsors and contacts
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Source ClinicalTrials.gov