Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ticagrelor OD administered with of water · 2 trials · 5 indications
Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).
Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).
Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).
Comparison of AUC(0-t) (Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).
Comparison of AUC (Area under plasma concentration-time curve from zero to infinity) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).
| Arm | Type | Description |
|---|---|---|
| Treatments A-D-B-C sequence | EXPERIMENTAL | Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4 |
| Treatments B-A-C-D sequence | EXPERIMENTAL | Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4 |
| Treatments C-B-D-A sequence | EXPERIMENTAL | Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4 |
| Treatments D-C-A-B sequence | EXPERIMENTAL | Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4 |
| Sequence ABC | EXPERIMENTAL | Treatment A in Period 1, Treatment B in Period 2 and Treatment C in Period 3 |
| Sequence BCA | EXPERIMENTAL | Treatment B in Period 1, Treatment C in Period 2 and Treatment A in Period 3 |
| Sequence CAB | EXPERIMENTAL | Treatment C in Period 1, Treatment A in Period 2 and Treatment B in Period 3 |
| Sequence ACB | EXPERIMENTAL | Treatment A in Period 1, Treatment C in Period 2 and Treatment B in Period 3 |
| Sequence BAC | EXPERIMENTAL | Treatment B in Period 1, Treatment A in Period 2 and Treatment C in Period 3 |
| Sequence CBA | EXPERIMENTAL | Treatment C in Period 1, Treatment B in Period 2 and Treatment A in Period 3 |
| Name | Type | Description |
|---|---|---|
| Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water | DRUG | 90 mg single dose |
| Ticagrelor OD tablet (90 mg single dose) administered without water | DRUG | 90 mg single dose |
| Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube | DRUG | 90 mg single dose |
| Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water | DRUG | 90 mg single dose |
| Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water | DRUG | Ticagrelor 90 mg OD tablet, single dose |
| Ticagrelor IR tablet (90 mg) administered with 150 mL of water | DRUG | Ticagrelor 90 mg IR tablet, single dose |
Inclusion Criteria: Healthy male and female subjects aged 18 to 55 years with suitable veins for cannulation or repeated venepuncture. - Females must have a negative pregnancy test at screening and on each admission to the clinical unit, must not be lactating, and must be of non-childbearing potent...
Ticagrelor OD administered with water refers to an orodispersible tablet formulation of ticagrelor given as a 90 mg single dose together with 150 mL or 200 mL of water. It is an investigational formulation studied in Phase 1 bioequivalence and bioavailability trials in healthy subjects.
Ticagrelor OD administered with water targets P2RY12, the platelet P2Y12 receptor. It acts as a negative allosteric modulator of this receptor, which is the same mechanism of action as other ticagrelor formulations.
Ticagrelor OD administered with water is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical studies evaluating this orodispersible tablet formulation.
Ticagrelor OD administered with water is in Phase 1 clinical development. It is an investigational formulation and has been evaluated in two completed Phase 1 trials, with no active trials currently listed.
Ticagrelor OD administered with water has been studied in two completed Phase 1 trials: NCT02436577, a bioequivalence study in Japanese subjects conducted in the United Kingdom with 51 participants, and NCT02400333, a bioavailability study in healthy subjects conducted in Germany with 100 participants.