Clinical trial

A Study to Assess the Relative Bioavailability of Different Subcutaneous Formulations ofAZD6234

Active, not recruiting · Phase 1 · 1 countries · Registry ID NCT07220954

Active, not recruitingPhase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 55 Years
SexAll
Healthy volunteersAccepted
ConditionHealthy Participants

Full registry criteria

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

Treatments and study arms

AZD6234 Formulation 1

Drug

AZD6234 Formulation 1 will be administered as a single SC injection

AZD6234 Formulation 2 (low concentration)

Drug

AZD6234 Formulation 2 (low concentration) will be administered as a single SC injection

AZD6234 Formulation 2 (high concentration)

Drug

AZD6234 Formulation 2 (high concentration) will be administered as a single SC injection

AZD6234 Formulation 3

Drug

AZD6234 Formulation 3 will be administered as a single SC injection

Primary outcomes

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Research Site🇬🇧 Ruddington, United Kingdom