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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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The main purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) of AZD4916 in healthy adult participants.
This is a single-blind, placebo-controlled study conducted at a single clinical unit.
The study will comprise of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD4916 | Experimental | Parts 1a and 2a participants will receive a single oral dose of AZD4916 on Day 1. Parts 1b and 2b participants will receive a single oral dose of AZD4916 on Day 1 and multiple doses of AZD4916 on Days 4 through 17. |
|
| Placebo | Placebo Comparator | Parts 1a and 2a participants will receive a single oral dose of placebo on Day 1. Parts 1b and 2b participants will receive a single dose placebo on Day 1 and multiple doses of placebo on Days 4 through 17. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD4916 | Drug | AZD4916 will be administered as oral solution. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | The safety and tolerability of AZD4916 following oral administration of single-ascending doses and multiple-ascending doses to healthy participants (including Japanese and Chinese) will be assessed. | From Screening (Day -29 to Day -2) up to 44 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under concentration-time curve from time zero to infinity (AUCinf) | The single-dose and steady-state PK of AZD4916 following oral administration of single-ascending doses and multiple-ascending doses of AZD4916 to healthy volunteers (including Japanese and Chinese healthy volunteers) will be characterised. | Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24 |
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Main Inclusion Criteria:
Main 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 | Glendale | California | 91206 | United States | ||
| Research Site |
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 |
| Other |
Placebo will be administered as oral solution. |
|
| Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) | The single-dose and steady-state PK of AZD4916 following oral administration of single-ascending doses and multiple-ascending doses of AZD4916 to healthy volunteers (including Japanese and Chinese healthy volunteers) will be characterised. | Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24 |
| Area under concentration-time curve in the dosing interval (AUCtau) | The single-dose and steady-state PK of AZD4916 following oral administration of single-ascending doses and multiple-ascending doses of AZD4916 to healthy volunteers (including Japanese and Chinese healthy volunteers) will be characterised. | Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24 |
| Maximum observed drug concentration (Cmax) | The single-dose and steady-state PK of AZD4916 following oral administration of single-ascending doses and multiple-ascending doses of AZD4916 to healthy volunteers (including Japanese and Chinese healthy volunteers) will be characterised. | Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24 |
| Harrow |
| HA1 3UJ |
| United Kingdom |