An Open-label, Randomized, Three-period, Crossover Study to Assess the Effect of Food and Calcium on S-888711 0.25-mg Tablet Pharmacokinetics in Healthy, Adult Volunteer Subjects Following a Single 0.75-mg Oral Dose of S-888711

Shionogi1 site in 1 country15 target enrollmentNovember 6, 2009

ConditionsHealthy Volunteer

InterventionsS-888711 Calcium Antacid

DrugsS-888711

Overview

Phase: Phase 1
Intervention: S-888711
Conditions: Healthy Volunteer
Sponsor: Shionogi
Enrollment: 15
Locations: 1
Primary Endpoint: Time to Maximum Observed Plasma Concentration of S-888711
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objectives of this study were:

To assess the effect of a high-fat diet on the pharmacokinetics (PK) of a 0.75 mg single dose of S-888711 orally administered as 0.25 mg tablets in healthy volunteer adults
To assess the effect of a calcium supplement on the PK of a 0.75 mg single dose of S-888711 orally administered as 0.25 mg tablets in healthy volunteer adults

Registry

clinicaltrials.gov

Start Date

November 6, 2009

End Date

December 23, 2009

Last Updated

7 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Shionogi

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A signed and dated written informed consent obtained prior to Screening.
•Males and females ≥ 18 and ≤ 70 years of age, inclusive (at the time of informed consent).
•Judged healthy at screening examination by the investigator.
•Body mass index (BMI) of ≥ 19 to ≤ 29.9 kg/m².
•All subjects must have agreed to use 2 forms of barrier contraception if engaging in sexual intercourse for at least 7 days prior to the first dose of study drug and continuing throughout the study, excluding subjects who had been surgically sterilized or females who had been postmenopausal (confirmed by follicle stimulating hormone test levels) for at least 1 year.
•All female subjects must have had a negative urine pregnancy test.
•Platelet count of 100,000 to 325,000/μL.
•Willing to submit to blood sampling for the planned PK analysis.

Exclusion Criteria

•The use of prescription or non-prescription drugs, including herbal medicine or dietary supplements, within 14 days prior to dosing, with the exception of up to 3 doses of acetaminophen ≤ 1 gram each permitted from 14 days prior to the first study drug dose through 72 hours prior to the first study drug dose.
•A history of regular use of tobacco- or nicotine-containing products within 6 months prior to Screening as confirmed by a urine cotinine test.
•A history of use of inhibitors or inducers of cytochrome P450 (CYP) 3A4 within 14 days prior to Screening.
•A history of use of platelet aggregation inhibitors, coronary artery vasodilators, calcium antagonists, beta blockers, diuretics, psychotropic drugs, prostaglandins, antibiotics, anticoagulants, and anticlotting or antiplatelet drugs (including aspirin and non-steroidal anti-inflammatory drugs) within 4 weeks prior to Screening.
•History of use of thrombocytopenia-inducing drugs (eg, quinidine, trimethoprim sulfamethoxazole, etc.) within 4 weeks prior to Screening.
•Family history of a hematologic disorder.
•Hemorrhagic tendency.
•A history of cardiac episode(s) or abnormal finding on electrocardiogram (ECG) and judged as ineligible by the investigator.
•Chronic disease requiring medication and/or other treatment such as dietary restriction and physical therapy.
•A history of anaphylaxis or significant side effect induced by a drug.

Arms & Interventions

Sequence 1

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.

Intervention: S-888711

Sequence 1

Intervention: Calcium Antacid

Sequence 2

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.

Intervention: S-888711

Sequence 2

Intervention: Calcium Antacid

Sequence 3

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.

Intervention: S-888711

Sequence 3

Intervention: Calcium Antacid