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

NCT07220954

Active Not RecruitingPhase 1

Sponsor: AstraZeneca

Conditions: Healthy Participants

Interventions: AZD6234 Formulation 1, AZD6234 Formulation 2 (low concentration), AZD6234 Formulation 2 (high concentration), AZD6234 Formulation 3

Countries: United Kingdom

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 overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Ruddington, United Kingdom