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This Phase I study will gather important information on the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5004 in both healthy Japanese participants and Japanese participants with T2DM.
This is a placebo-controlled study to assess the safety, efficacy, tolerability, and PK of single and repeated dosing of AZD5004 compared with placebo.
Participants who are eligible according to the inclusion/exclusion criteria will be randomized to receive AZD5004 or matching placebo.
The study will comprise:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A-AZD5004 | Experimental | Participants will receive AZD5004 orally. |
|
| Part A-Placebo | Placebo Comparator | Participants will receive matching Placebo orally. |
|
| Part B-AZD5004 | Experimental | Participants will receive AZD5004 orally. |
|
| Part B-Placebo | Placebo Comparator | Participants will receive matching Placebo orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD5004(Part A) | Drug | Single dose of AZD5004 oral on Day1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PartA: Number of participants with adverse events (AEs) and serious adverse events (SAEs) | To assess the safety and tolerability of AZD5004 following single oral doses in healthy participants. | From screening (Day -28) to last follow up visit (Day 8) |
| PartB: Number of participants with adverse events (AEs) and serious adverse events (SAEs) | To assess the safety and tolerability of AZD5004 following multiple oral ascending doses in participants with T2DM. | From screening (Day -28) to last follow up visit (Day 119 ) |
| Measure | Description | Time Frame |
|---|---|---|
| PartB: AUC0-4 for glucose, insulin and C-peptide for MMTT | To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD | From Day 1 to Day 105 |
| PartB: Absolute change from baseline to Day 105 in fasting plasma glucose |
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Inclusion Criteria:
Inclusion Criteria for Part A:
Inclusion Criteria for Part B:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Osaka | 532-0003 | Japan |
Qualified researchers can request access to anonymized individual patient-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 refer 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. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| Placebo(Part A) |
| Drug |
Single dose of placebo oral on Day1 |
|
| AZD5004(Part B) | Drug | AZD5004 will be administered as an oral tablet once daily. |
|
| Placebo(Part B) | Drug | Placebo will be administered as an oral tablet once daily. |
|
To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD |
| From Day 1 to Day 105 |
| PartB: % change from baseline to Day 105 in HOMA-IR | To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD | From Day 1 to Day 105 |
| PartB: The proportion of time in hyperglycaemia /hypoglycaemia over the last 7-day intervals at each dose level in CGM | To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD | From Day 1 to Day 106 |
| PartB: % change from baseline to Day 105 in body weight (kg) | To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD | From Day 1 to Day 105 |
| PartB: % change from baseline to Day 105 in waist circumference (cm) | To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD | From Day 1 to Day 105 |
| PartA: Area under the Plasma Concentration vs. Time Curve(AUC0-24) | To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD | From Day 1 to Day 6 |
| PartA: Area under the Plasma Concentration vs. Time Curve from Zero until the Time of the Last Concentration above the Limit of Quantification(AUC0-tlast) | To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD | From Day 1 to Day 6 |
| PartA: Area under the Plasma Concentration vs. Time Curve from Zero to Infinity(AUC0-inf) | To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD | From Day 1 to Day 6 |
| PartA: Maximum Observed Plasma Concentration(Cmax) | To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD | From Day 1 to Day 6 |
| PartA: Plasma Concentration at 24 Hours Post-Dose(C24h) | To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD | From Day 1 to Day 6 |
| PartA: Time of Occurrence of Maximum Plasma Concentration(tmax) | To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD | From Day 1 to Day 6 |
| PartA: Lag Time before Observation of Quantifiable Analyte Concentrations in Plasma(tlag) | To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD | From Day 1 to Day 6 |
| PartA: Half-Life(t1/2) | To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD | From Day 1 to Day 6 |
| PartA: Last measurable Non-Zero Concentration(Clast) | To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD | From Day 1 to Day 6 |
| PartA: Last measurable Non-Zero ConcentrationTime to Last Detectable Concentration(tlast) | To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD | From Day 1 to Day 6 |
| PartA: Apparent Oral Clearance(CL/F) | To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD | From Day 1 to Day 6 |
| PartA: Cumulative Urinary Excretion(Ae) | To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD | From Day 1 to Day 6 |
| PartA: Clearance(CLR) | To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD | From Day 1 to Day 6 |
| PartB: Area under the Plasma Concentration vs. Time Curve(AUC0-24) | To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD | Day 1 |
| PartB: Maximum Observed Plasma Concentration(Cmax) | To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD | Day 1, Day 49, Day 63, Day 77, Day91, Day105 |
| PartB: Plasma Concentration at 24 Hours Post-Dose(C24h) | To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD | Day 1 |
| PartB: Time of Occurrence of Maximum Plasma Concentration(tmax) | To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD | Day 1, Day 49, Day 63, Day 77, Day91, Day105 |
| PartB: Lag Time before Observation of Quantifiable Analyte Concentrations in Plasma(tlag) | To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD | Day 1 |
| PartB: Area under the Plasma Concentration vs. Time Curve over the Dosing Interval(AUC0-τ) | To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD | Day 49, Day 63, Day 77, Day 91, Day 105 |
| PartB: Observed Concentration at the End of the Dosing Interval(Cτ) | To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD | Day 49, Day 63, Day 77, Day 91, Day 105 |
| PartB: Half-Life(t1/2) | To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD | Day 49, Day 63, Day 77, Day 91, Day 105 |
| PartB: Apparent Oral Clearance(CL/F) | To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD | Day 49, Day 63, Day 77, Day 91, Day 105 |
| PartB: Cumulative Urinary Excretion(Ae) | To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD | Day 105 |
| PartB: Clearance(CLR) | To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD | Day 105 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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