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

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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 )

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

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: S-888711 Dietary Supplement: Calcium Antacid Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 6, 2009
Actual Primary Completion Date : December 23, 2009
Actual Study Completion Date : December 23, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
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.
Drug: S-888711
Administered orally as three 0.25 mg tablets

Dietary Supplement: Calcium Antacid
Calcium carbonate 4000 mg chewable tablets

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

Dietary Supplement: Calcium Antacid
Calcium carbonate 4000 mg chewable tablets

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

Dietary Supplement: Calcium Antacid
Calcium carbonate 4000 mg chewable tablets




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]

Secondary Outcome Measures :
  1. Number of Participants with Treatment-emergent Adverse Events [ Time Frame: up to 40 days ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897413


Locations
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United States, Texas
Healthcare Discoveries, LLC
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Shionogi
Investigators
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Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line Shionogi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shionogi
ClinicalTrials.gov Identifier: NCT03897413     History of Changes
Other Study ID Numbers: 0924M0618
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Calcium, Dietary
Calcium Carbonate
Antacids
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents