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

AstraZeneca

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: AZD6234 Formulation 2 (high concentration); Drug: AZD6234 Formulation 2 (low concentration); Drug: AZD6234 Formulation 1; Drug: AZD6234 Formulation 3

Study type: Interventional

Funder types: Industry

Identifiers

NCT07220954

D8750C00008

Details and patient eligibility

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.

Full description

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.

It plans to enrol 21 healthy men and women aged 18-55 years.

Each volunteer will take part in 4 treatment periods and receive different formulations of AZD6234, by injection under the skin into the abdomen (stomach). In each period they'll be given a single dose without food. They'll stay in the clinic for 6 nights on 4 occasions, attend up to 10 outpatient visits, and take up to 19 weeks to finish the study.

Blood and urine samples will be collected to: measure the amount of AZD6234 and its breakdown products, do safety tests and assess the effect of the test medicine on the immune system response.

Enrollment: 21 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

Sequence ABCD

Experimental group

Description:

Participants will receive a single SC injection of AZD6234 in each of four study periods, Treatment A in Period 1, Treatment B in Period 2, Treatment C in Period 3 and Treatment D in Period 4 (Where A is AZD6234 Formulation 1, B is AZD6234 Formulation 2 (low concentration), C is AZD6234 Formulation 2 (high concentration) and D is AZD6234 Formulation 3)

Treatment:

Drug: AZD6234 Formulation 3

Drug: AZD6234 Formulation 1

Drug: AZD6234 Formulation 2 (low concentration)

Drug: AZD6234 Formulation 2 (high concentration)

Sequence BCAD

Experimental group

Description:

Participants will receive a single SC injection of AZD6234 in each of four study periods, Treatment B in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment D in Period 4 (Where A is AZD6234 Formulation 1, B is AZD6234 Formulation 2 (low concentration), C is AZD6234 Formulation 2 (high concentration) and D is AZD6234 Formulation 3)

Treatment:

Drug: AZD6234 Formulation 3

Drug: AZD6234 Formulation 1

Drug: AZD6234 Formulation 2 (low concentration)

Drug: AZD6234 Formulation 2 (high concentration)

Sequence CABD

Experimental group

Description:

Participants will receive a single SC injection of AZD6234 in each of four study periods, Treatment C in Period 1, Treatment A in Period 2, Treatment B in Period 3 and Treatment D in Period 4 (Where A is AZD6234 Formulation 1, B is AZD6234 Formulation 2 (low concentration), C is AZD6234 Formulation 2 (high concentration) and D is AZD6234 Formulation 3)

Treatment:

Drug: AZD6234 Formulation 3

Drug: AZD6234 Formulation 1

Drug: AZD6234 Formulation 2 (low concentration)

Drug: AZD6234 Formulation 2 (high concentration)