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Study to investigate if the uptake of Ticagrelor into the body differs depending on method of administration.
Study to evaluate the bioavailability of the crushed ticagrelor tablets when administered orally or through nasogastric tubes compared to whole ticagrelor tablets given orally
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Ticagrelor 90 mg as a whole tablet |
|
| B | Experimental | Ticagrelor 90 mg tablet crushed and suspended in water |
|
| C | Experimental | Dispersed ticagrelor 90 mg tablet suspended in water and administered through a nasogastric tube into the the stomach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor 90 mg whole tablet | Drug | Ticagrelor 90 mg whole tablet administered as a single oral dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Description of the pharmacokinetic(PK) profile in terms of plasma concentration-time curve (AUC) of ticagrelor | PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose | |
| Description of the pharmacokinetic(PK) profile in terms of AUC of the active metabolite of ticagrelor | PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose | |
| Description of the pharmacokinetic(PK) profile in terms of maximum plasma concentration (Cmax) of ticagrelor | PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose | |
| Description of the pharmacokinetic(PK) profile in terms of Cmax of the active metabolite of ticagrelor | PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Description of the safety profile in terms of adverse events (AE) | From first dose through to the follow-up visit. | |
| Description of the safety profile in terms of laboratory variables | Safety labs at screening, Day -1, Day 3 (48 hours after treatment) and follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith Hsia, MD | AstraZeneca, Wilmington, US | Study Director |
| Mirjana Kujacic, MD | AstraZeneca Mölndal, Sweden | Study Chair |
| Saeed Kahn, MBBS | Quintiles London, United Kingdom | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom |
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| Ticagrelor 90 mg tablet crushed |
| Drug |
Ticagrelor 90 mg crushed and suspended in water |
|
| Dispersed ticagrelor 90 mg tablet suspended in water - nasogastric tube | Drug | Dispersed 90 mg ticagrelor 90 mg tablet suspended in water and administered through a nasogastric tube into the stomach |
|
| Description of the safety profile in terms of vital signs | Vital signs at screening, pre-dose, 1 h, 3, 6, 12 and 24 hours post-dose, Day 3 for all treatment periods and follow-up |
| Description of the safety profile in terms of physical examination findings | Physical examination at screening, pre-dose, Day 3 and follow-up |
| Description of the safety profile in terms of Electrocardiogram (ECG) | ECGs at screening, Day 3 and follow-up |
| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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