Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03897413
Recruitment Status : Completed
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )

Tracking Information
First Submitted Date  ICMJE March 29, 2019
First Posted Date  ICMJE April 1, 2019
Last Update Posted Date April 1, 2019
Actual Study Start Date  ICMJE November 6, 2009
Actual Primary Completion Date December 23, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
  • Maximum Observed Plasma Concentration of S-888711 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Predose and 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours after dosing ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
Number of Participants with Treatment-emergent Adverse Events [ Time Frame: up to 40 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Food and Calcium on Pharmacokinetics of a Single Dose of S-888711 in Healthy Adult Volunteers
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteer
Intervention  ICMJE
  • Drug: S-888711
    Administered orally as three 0.25 mg tablets
  • Dietary Supplement: Calcium Antacid
    Calcium carbonate 4000 mg chewable tablets
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Drug: S-888711
    • Dietary Supplement: Calcium Antacid
  • Experimental: 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.
    Interventions:
    • Drug: S-888711
    • Dietary Supplement: Calcium Antacid
  • Experimental: 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.
    Interventions:
    • Drug: S-888711
    • Dietary Supplement: Calcium Antacid
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2019)
15
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 23, 2009
Actual Primary Completion Date December 23, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03897413
Other Study ID Numbers  ICMJE 0924M0618
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shionogi Inc. ( Shionogi )
Study Sponsor  ICMJE Shionogi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line Shionogi
PRS Account Shionogi Inc.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP