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| Name | Class |
|---|---|
| Quotient Sciences | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence ABCD | Experimental | 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) |
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| Sequence BCAD | Experimental | 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) |
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| Sequence CABD | Experimental | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6234 Formulation 1 | Drug | AZD6234 Formulation 1 will be administered as a single SC injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Assess relative bioavailability (rBA) by comparing the pharmacokinetics (PK) of different AZD6234 SC formulations | 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) | Assess relative bioavailability (rBA) by comparing the pharmacokinetics (PK) of different AZD6234 SC formulations | 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) | Assess relative bioavailability (rBA) by comparing the pharmacokinetics (PK) of different AZD6234 SC formulations | Plasma sample collection from pre- dose to 30 days post final dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events (AEs)/serious AEs (SAEs), and change from baseline for vital signs, electrocardiograms (ECGs), and laboratory safety tests | Safety and tolerability of different AZD6234 SC formulations | Through study duration, approximately 19 weeks |
| Time of maximum observed plasma concentration (tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Ruddington | NG11 6JS | United Kingdom |
Qualified researchers can request access to anonymized individual participant-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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Participants will be randomized to 1 of 3 treatment sequences
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| AZD6234 Formulation 2 (low concentration) | Drug | AZD6234 Formulation 2 (low concentration) will be administered as a single SC injection |
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| AZD6234 Formulation 2 (high concentration) | Drug | AZD6234 Formulation 2 (high concentration) will be administered as a single SC injection |
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| AZD6234 Formulation 3 | Drug | AZD6234 Formulation 3 will be administered as a single SC injection |
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Pharmacokinetics (PK) of different AZD6234 SC formulations |
| Plasma sample collection from pre- dose to 30 days post final dose |
| Terminal elimination half-life (t1/2) | Pharmacokinetics (PK) of different AZD6234 SC formulations | 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) | Pharmacokinetics (PK) of different AZD6234 SC formulations | 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) | Pharmacokinetics (PK) of different AZD6234 SC formulations | Plasma sample collection from pre- dose to 30 days post final dose |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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