Healthy Participants
Conditions
Keywords
Relative Bioavailability, Pharmacokinetics, Obesity, Overweight
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.
Interventions
DRUGAZD6234 Formulation 1
AZD6234 Formulation 1 will be administered as a single SC injection
DRUGAZD6234 Formulation 2 (low concentration)
AZD6234 Formulation 2 (low concentration) will be administered as a single SC injection
DRUGAZD6234 Formulation 2 (high concentration)
AZD6234 Formulation 2 (high concentration) will be administered as a single SC injection
DRUGAZD6234 Formulation 3
AZD6234 Formulation 3 will be administered as a single SC injection
Sponsors
AstraZeneca
Quotient Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized to 1 of 3 treatment sequences
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
United Kingdom
Outcome results
None listed