A Study to Assess the Relative Bioavailability of Different Subcutaneous Formulations ofAZD6234
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AZD6234 Formulation 1, AZD6234 Formulation 2 (low concentration), AZD6234 Formulation 2 (high concentration), AZD6234 Formulation 3.
- Who it may be relevant to
- Registry conditions: Healthy Participants. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase I, Single-Dose, Open-Label, Sequential, Randomised, Crossover Study to Assess the Relative Bioavailability of Different Subcutaneous Formulations of AZD6234 in Participants Living With Overweight or Obesity
Overview
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
- Drug AZD6234 Formulation 1
AZD6234 Formulation 1 will be administered as a single SC injection - Drug AZD6234 Formulation 2 (low concentration)
AZD6234 Formulation 2 (low concentration) will be administered as a single SC injection - Drug AZD6234 Formulation 2 (high concentration)
AZD6234 Formulation 2 (high concentration) will be administered as a single SC injection - Drug AZD6234 Formulation 3
AZD6234 Formulation 3 will be administered as a single SC injection
Primary outcome measures
- Maximum observed plasma concentration (Cmax) [Time frame: Plasma sample collection from pre- dose to 30 days post final dose]
- Area under the concentration-time curve from time 0 to the time of the last measurable concentration (AUC0-t) [Time frame: Plasma sample collection from pre- dose to 30 days post final dose]
- Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) [Time frame: Plasma sample collection from pre- dose to 30 days post final dose]
Secondary outcome measures (5)
- Number of subjects with adverse events (AEs)/serious AEs (SAEs), and change from baseline for vital signs, electrocardiograms (ECGs), and laboratory safety tests [Time frame: Through study duration, approximately 19 weeks]
- Time of maximum observed plasma concentration (tmax) [Time frame: Plasma sample collection from pre- dose to 30 days post final dose]
- Terminal elimination half-life (t1/2) [Time frame: Plasma sample collection from pre- dose to 30 days post final dose]
- Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F) [Time frame: Plasma sample collection from pre- dose to 30 days post final dose]
- 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) [Time frame: Plasma sample collection from pre- dose to 30 days post final dose]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United Kingdom · 1 center
- Research Site — Ruddington
Identifiers
NCT: NCT07220954 · D8750C00008