A Study to Assess the Relative Bioavailability of Different Subcutaneous Formulations ofAZD6234
Not Applicable
Not yet recruiting
- Conditions
- Healthy Participants
- Interventions
- Drug: AZD6234 Formulation 1Drug: AZD6234 Formulation 2 (low concentration)Drug: AZD6234 Formulation 2 (high concentration)Drug: AZD6234 Formulation 3
- Registration Number
- NCT07220954
- Lead Sponsor
- AstraZeneca
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 21
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence ABCD AZD6234 Formulation 1 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) Sequence ABCD AZD6234 Formulation 2 (low concentration) 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) Sequence ABCD AZD6234 Formulation 2 (high concentration) 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) Sequence ABCD AZD6234 Formulation 3 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) Sequence BCAD AZD6234 Formulation 1 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) Sequence BCAD AZD6234 Formulation 2 (low concentration) 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) Sequence BCAD AZD6234 Formulation 2 (high concentration) 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) Sequence BCAD AZD6234 Formulation 3 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) Sequence CABD AZD6234 Formulation 1 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) Sequence CABD AZD6234 Formulation 2 (low concentration) 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) Sequence CABD AZD6234 Formulation 2 (high concentration) 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) Sequence CABD AZD6234 Formulation 3 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)
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Number of subjects with adverse events (AEs)/serious AEs (SAEs), and change from baseline for vital signs, electrocardiograms (ECGs), and laboratory safety tests Through study duration, approximately 19 weeks Safety and tolerability of different AZD6234 SC formulations
Time of maximum observed plasma concentration (tmax) Plasma sample collection from pre- dose to 30 days post final dose Pharmacokinetics (PK) of different AZD6234 SC formulations
Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F) Plasma sample collection from pre- dose to 30 days post final dose Pharmacokinetics (PK) of different AZD6234 SC formulations
Terminal elimination half-life (t1/2) Plasma sample collection from pre- dose to 30 days post final dose Pharmacokinetics (PK) of different AZD6234 SC formulations
Volume of distribution based on the terminal phase calculated using AUC0-inf after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F) Plasma sample collection from pre- dose to 30 days post final dose Pharmacokinetics (PK) of different AZD6234 SC formulations
Trial Locations
- Locations (1)
Research Site
🇬🇧Ruddington, United Kingdom
Research Site🇬🇧Ruddington, United Kingdom