AstraZeneca
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.
This Phase I, open-label, parallel group study will investigate the single SC dose PK, safety, tolerability, and immunogenicity of separate administrations of AZD9550 and AZD6234 to male and female participants with severe and moderate hepatic impairment compared to matched controls with normal hepatic function. To minimize any potential impact from AZD9550 administered in Period 1, AZD6234 will be administered in Period 2 following a washout period. Results from separate injections will ultimately inform the single dose PK, safety, and tolerability of AZD9550 and AZD6234 administered. Appro…
Inclusion Criteria 1. Age 18-85 years at consent. 2. Groups: * 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). 3. Stable concomitant regimen ≥2 weeks before screening (Groups 1-2). 4. T2DM allowed if HbA1c \<10% and no severe hypo/hyperglycaemia or hospitalisation within 6 months. 5. Body weight ≥50 kg; BMI 18-42 kg/m². 6. Sex assigned at birth (male/female); contraception per local regulations. F…
Single subcutaneous dose of AZD6234 in participants from all groups
Single subcutaneous dose of AZD9550 in participants from all groups
Arctuva estimate
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