Effect of Food and Calcium on Pharmacokinetics of a Single Dose of S-888711 in Healthy Adult Volunteers
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 4/3/2019 |
Start Date: | November 6, 2009 |
End Date: | December 23, 2009 |
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
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
- 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
Inclusion Criteria:
1. A signed and dated written informed consent obtained prior to Screening.
2. Males and females ≥ 18 and ≤ 70 years of age, inclusive (at the time of informed
consent).
3. Judged healthy at screening examination by the investigator.
4. Body mass index (BMI) of ≥ 19 to ≤ 29.9 kg/m².
5. 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.
6. All female subjects must have had a negative urine pregnancy test.
7. Platelet count of 100,000 to 325,000/μL.
8. Willing to submit to blood sampling for the planned PK analysis.
Exclusion Criteria:
1. 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.
2. A history of regular use of tobacco- or nicotine-containing products within 6 months
prior to Screening as confirmed by a urine cotinine test.
3. A history of use of inhibitors or inducers of cytochrome P450 (CYP) 3A4 within 14 days
prior to Screening.
4. 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.
5. History of use of thrombocytopenia-inducing drugs (eg, quinidine, trimethoprim
sulfamethoxazole, etc.) within 4 weeks prior to Screening.
6. Family history of a hematologic disorder.
7. Hemorrhagic tendency.
8. A history of cardiac episode(s) or abnormal finding on electrocardiogram (ECG) and
judged as ineligible by the investigator.
9. Chronic disease requiring medication and/or other treatment such as dietary
restriction and physical therapy.
10. A history of anaphylaxis or significant side effect induced by a drug.
11. A history of allergic symptoms including food allergy, but excluding inactive pollen
allergy.
12. A history of abuse of alcohol and/or drugs.
13. Positive urine screen for drug abuse.
14. A history of gastrointestinal surgery making subject ineligible as judged by the
investigator.
15. Judged ineligible for this study by the investigator due to a history or clinical
manifestations of significant metabolic, hepatic, renal, hematological, pulmonary,
cardiovascular, gastrointestinal, or urological disease or other clinically important
disorder.
16. Positive laboratory results for hepatitis A IgM antibody, hepatitis B surface antigen,
hepatitis C antibody, or human immunodeficiency virus at Screening.
17. Donation of >400 mL of blood within 12 weeks or >200 mL of blood within 4 weeks prior
to Screening.
18. Prior administration of S-888711.
19. Use of other investigational products within 30 days or 6 half-lives (whichever was
longer) prior to the first dose of study medication.
20. Judged ineligible for this study by the investigator for any other reason.
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