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The primary objectives of this study were:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Participants received a single oral dose of 0.75 mg S-888711 in the fasted state in treatment period 1, a single oral dose of 0.75 mg S-888711 in the fed state in period 2, and a single oral dose of 0.75 mg S-888711 in the fasted state with 4000 mg of calcium carbonate in period 3. Each period consisted of 6 days, separated by a 5-day washout period. |
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| Sequence 2 | Experimental | Participants received a single oral dose of 0.75 mg S-888711 in the fed state in treatment period 1, a single oral dose of 0.75 mg S-888711 in the fasted state with 4000 mg of calcium carbonate in period 2, and a single oral dose of 0.75 mg S-888711 in the fasted state in period 3. Each period consisted of 6 days, separated by a 5-day washout period. |
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| Sequence 3 | Experimental | Participants received a single oral dose of 0.75 mg S-888711 in the fasted state with 4000 mg of calcium carbonate in treatment period 1, a single oral dose of 0.75 mg S-888711 in the fasted state in period 2, and a single oral dose of 0.75 mg S-888711 in the fed state in period 3. Each period consisted of 6 days, separated by a 5-day washout period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-888711 | Drug | Administered orally as three 0.25 mg tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration of S-888711 | Predose and 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours after dosing | |
| Time to Maximum Observed Plasma Concentration of S-888711 | Predose and 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours after dosing | |
| Area Under the Concentration-time Curve from Time Zero to the Time Point of the Last Quantifiable Concentration of S-888711 | Predose and 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours after dosing | |
| Area Under the Concentration-time Curve from Time Zero to Infinity of S-888711 | Predose and 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours after dosing | |
| Terminal Elimination Half-life of S-888711 | Predose and 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours after dosing | |
| Apparent Total Clearance of S-888711 | Predose and 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Events | up to 40 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shionogi Clinical Trials Administrator Clinical Support Help Line | Shionogi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healthcare Discoveries, LLC | San Antonio | Texas | 78209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31303281 | Derived | Katsube T, Wajima T, Fukuhara T, Kano T. Effects of Food and Calcium Carbonate on the Pharmacokinetics of Lusutrombopag, a Novel Thrombopoietin Receptor Agonist. Clin Ther. 2019 Sep;41(9):1747-1754.e2. doi: 10.1016/j.clinthera.2019.06.004. Epub 2019 Jul 11. |
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| ID | Term |
|---|---|
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
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| Calcium Antacid | Dietary Supplement | Calcium carbonate 4000 mg chewable tablets |
|
| D017554 |
| Carbon Compounds, Inorganic |
| D008903 | Minerals |