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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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The main aim of this study to compare the pharmacokinetics (PK) of two formulations of AZD4144 and assess the effect of food and omeprazole on PK of AZD4144 in healthy participants.
This is an open-label, randomized, single-dose, crossover Phase I study.
The study will comprise:
This study includes the following 2 arms:
Arm 1 consists of 3 treatments:
Arm 2 consists of 3 treatments:
The participants will be randomised to one of the following treatment sequences:
Arm 1: ABC, BCA or CAB Arm 2: DEF or EDF
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: AZD4144 | Experimental | Participants will receive single doses of AZD4144 dose 1 as tablet formulation (Treatments A and B) and as an oral solution formulation (Treatment C) under fasted (Treatments A and C) and fed (Treatment B) conditions. |
|
| Arm 2: AZD4144 + Omeprazole | Experimental | Participants will receive single doses of AZD4144 dose 2 tablet formulation under fasted (Treatment D) and fed (Treatment E) conditions and co-administered with omeprazole (Treatment F). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD4144 | Drug | Participants will receive AZD4144 orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under concentration-time curve from time 0 to infinity (AUCinf) of AZD4144 |
| Days 1-4, Days 8-11 and Days 15-18 |
| Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of AZD4144 |
| Days 1-4, Days 8-11 and Days 15-18 |
| Maximum observed drug concentration (Cmax) of AZD4144 |
| Days 1-4, Days 8-11 and Days 15-18 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | To assess the safety and tolerability of single doses of AZD4144 in healthy participants. | From Day 1 to Day 25 |
| Number of participants with serious AEs |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Harrow | HA1 3UJ | United Kingdom |
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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| Omeprazole | Drug | Participants will receive omeprazole orally. |
|
To assess the safety and tolerability of single doses of AZD4144 in healthy participants.
| From Screening (Day -28 to Day -2) to Day 25 |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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