AZD6234 Formulation 1: AZD6234 Formulation 1 will be administered as a single SC injection
AZD6234 Formulation 2 (low concentration): AZD6234 Formulation 2 (low concentration) will be administered as a single SC injection
AZD6234 Formulation 2 (high concentration): AZD6234 Formulation 2 (high concentration) will be administered as a single SC injection
AZD6234 Formulation 3: AZD6234 Formulation 3 will be administered as a single SC injection
Study summary
This study in healthy volunteers aims to compare blood levels and side effects after administration of different formulations of AZD6234.
This study will take place at one site in Nottingham, United Kingdom, and will enrol 21 healthy men and women aged 18-55 years.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Healthy males or non-pregnant, non-lactating females aged 18 to 55 years inclusive
* BMI of 25.0 to 35.0 kg/m2 inclusive and weight ≥50 kg
Exclusion Criteria:
* History of any clinically important disease or disorder
* History or presence of clinically significant cardiovascular, renal, hepatic, dermatological, respiratory, neurological, psychiatric or gastrointestinal disorder including a history of pancreatitis or gall stones
* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the planned first dosing day
* Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis
* Any clinically significant abnormal findings in vital signs
* Any clinically significant abnormalities on 12-lead ECG
* HbA1c ≥6.5% (≥48 mmol/mol)
* Evidence of renal impairment
* Females who are pregnant or lactating.
* Any participant who has received an amylin analogue containing preparation within the last 30 days or 5 half-lives of the drug (whichever is longer)
* Participants who report to have previously received AZD6234.
* Use of any prescribed or non-prescribed medication
Primary outcome measure(s)
Maximum observed plasma concentration (Cmax) — Plasma sample collection from pre- dose to 30 days post final dose Assess relative bioavailability (rBA) by comparing the pharmacokinetics (PK) of different AZD6234 SC formulations
Area under the concentration-time curve from time 0 to the time of the last measurable concentration (AUC0-t) — Plasma sample collection from pre- dose to 30 days post final dose Assess relative bioavailability (rBA) by comparing the pharmacokinetics (PK) of different AZD6234 SC formulations
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) — Plasma sample collection from pre- dose to 30 days post final dose Assess relative bioavailability (rBA) by comparing the pharmacokinetics (PK) of different AZD6234 SC formulations
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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