- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03897413
Effect of Food and Calcium on Pharmacokinetics of a Single Dose of S-888711 in Healthy Adult Volunteers
March 29, 2019 updated by: Shionogi
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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San Antonio, Texas, United States, 78209
- Healthcare Discoveries, LLC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
- A history of allergic symptoms including food allergy, but excluding inactive pollen allergy.
- A history of abuse of alcohol and/or drugs.
- Positive urine screen for drug abuse.
- A history of gastrointestinal surgery making subject ineligible as judged by the investigator.
- 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.
- Positive laboratory results for hepatitis A IgM antibody, hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus at Screening.
- Donation of >400 mL of blood within 12 weeks or >200 mL of blood within 4 weeks prior to Screening.
- Prior administration of S-888711.
- Use of other investigational products within 30 days or 6 half-lives (whichever was longer) prior to the first dose of study medication.
- Judged ineligible for this study by the investigator for any other reason.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
Administered orally as three 0.25 mg tablets
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.
|
Administered orally as three 0.25 mg tablets
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.
|
Administered orally as three 0.25 mg tablets
Calcium carbonate 4000 mg chewable tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
|
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
|
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
|
Predose and 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours after dosing
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants with Treatment-emergent Adverse Events
Time Frame: up to 40 days
|
up to 40 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 6, 2009
Primary Completion (ACTUAL)
December 23, 2009
Study Completion (ACTUAL)
December 23, 2009
Study Registration Dates
First Submitted
March 29, 2019
First Submitted That Met QC Criteria
March 29, 2019
First Posted (ACTUAL)
April 1, 2019
Study Record Updates
Last Update Posted (ACTUAL)
April 1, 2019
Last Update Submitted That Met QC Criteria
March 29, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0924M0618
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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