Effect of Food and Calcium on Pharmacokinetics of a Single Dose of S-888711 in Healthy Adult Volunteers

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03897413
• Other study ID #: 0924M0618
• Status: Completed
• Phase: Phase 1
• Start date: November 6, 2009
• Est. completion date: December 23, 2009

Study information

• Verified date: March 2019
• Source: Shionogi Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 23, 2009
• Est. primary completion date: December 23, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• S-888711
Administered orally as three 0.25 mg tablets

Dietary Supplement:
• Calcium Antacid
Calcium carbonate 4000 mg chewable tablets

Locations

Country	Name	City	State
United States	Healthcare Discoveries, LLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Shionogi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	Number of Participants with Treatment-emergent Adverse Events		up to 40 days