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The Safety, Tolerability and Pharmacokinetic Study of Litapiprant Tablets in Healthy Male and Female Subjects

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: NCT03663686
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Sunshine Lake Pharma Co., Ltd.

Tracking Information
First Submitted Date  ICMJE September 2, 2018
First Posted Date  ICMJE September 10, 2018
Last Update Posted Date July 27, 2020
Actual Study Start Date  ICMJE October 25, 2018
Actual Primary Completion Date January 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
Adverse events [ Time Frame: Baseline to day 8~10 ]
To assess the safety and tolerability after a single dose of Litapiprant Tablets
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
  • AUC0-∞ [ Time Frame: Prior to dosing(0 hour)and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing ]
    area under the concentration versus time curve (AUC) from time zero to infinity
  • AUC0-t [ Time Frame: Prior to dosing(0 hour)and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing ]
    AUC from time zero to the time of the last quantifiable concentration time zero to the time of the last quantifiable concentration
  • Cmax [ Time Frame: Prior to dosing(0 hour)and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing ]
    maximum observed plasma concentration
  • tmax [ Time Frame: Prior to dosing(0 hour)and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing ]
    time of the maximum observed plasma concentration
  • t½ [ Time Frame: Prior to dosing(0 hour)and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing ]
    apparent terminal elimination half-life
  • Vz/F [ Time Frame: Prior to dosing(0 hour)and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing ]
    apparent volume of distribution
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 The Safety, Tolerability and Pharmacokinetic Study of Litapiprant Tablets in Healthy Male and Female Subjects
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Single-center Study to Assess the Safety, Tolerability and Pharmacokinetic of Litapiprant Tablets in Healthy Subjects
Brief Summary The Safety, Tolerability and Pharmacokinetic Study of Asthma Treatment Drug Litapiprant Tablets in Healthy Male and Female subjects.
Detailed Description This was a Randomized,Double-blind, Placebo-controlled, Single Ascending Dose, Single-center Study to Assess the Safety, Tolerability and Pharmacokinetic of Litapiprant Tablets in Healthy Male and Female subjects. A total of 60 healthy subjects were divided into 7 groups. Group 1 consist of 4 subjects, 3 subjects will receive Litapiprant Tablets and 1 subject will receive placebo.Group 2,3,5,6 consist of 8 subjects respectively, in each group, 6 subjects will receive Litapiprant Tablets and 2 subjects will receive placebo.Group 4,7 consist of 12 subjects respectively, in each group, 10 subjects will receive Litapiprant Tablets and 2 subjects will receive placebo.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE Drug: Litapiprant Tablet
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
Study Arms  ICMJE
  • Placebo Comparator: 25mg single doses
    Intervention Drug: 25mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
    Intervention: Drug: Litapiprant Tablet
  • Placebo Comparator: 50mg single doses
    Intervention Drug: 50mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
    Intervention: Drug: Litapiprant Tablet
  • Placebo Comparator: 100mg single doses
    Intervention Drug: 100mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
    Intervention: Drug: Litapiprant Tablet
  • Placebo Comparator: 200mg single doses
    Intervention Drug: 200mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
    Intervention: Drug: Litapiprant Tablet
  • Placebo Comparator: 400mg single doses
    Intervention Drug: 400mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
    Intervention: Drug: Litapiprant Tablet
  • Placebo Comparator: 600mg single doses
    Intervention Drug: 600mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
    Intervention: Drug: Litapiprant Tablet
  • Placebo Comparator: 800mg single doses
    Intervention Drug: 800mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
    Intervention: Drug: Litapiprant Tablet
Publications * Not Provided

*   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: September 6, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 30, 2019
Actual Primary Completion Date January 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, overall healthy subjects,female VS male 1:1 ratio;
  • Between 18 and 45 years of age, inclusive, similar ages;
  • Body weight should be≥50 kg; Body Mass Index (BMI) is between 19.0 and 28.0 kg/m2, inclusive;
  • Able to comprehend and sign the ICF voluntarily prior to initiate the study;
  • Able to communicate well with the investigator and complete the study according to the protocol.

Exclusion Criteria:

  • Pregnant or nursing female, or plan for pregnancy within 6 months;
  • A clinically significant abnormal finding on the physical exam, medical history, electrocardiogram (ECG), or clinical laboratory results at screening;
  • Has a positive test for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, or HIV antibody . A clinically significant abnormal finding on HBV-DNA test ;
  • Sitting systolic blood pressure (SBP) <90mmHg or >140mmHg, and/or sitting diastolic blood pressure (DBP) <60mmHg or >90mmHg at screening;
  • With the history of using any drug which will inhibit or induce liver metabolize drug and/or will infect gastric acid within 1 month before randomization;
  • Receipt of any medication including over the counter preparations and vitamins within 14 days of the first study day;
  • History of cardiovascular, immune system, Severe digestive system, Circulatory system, respiratory system, urinary system , nervous system,tumor diseases;
  • Suffering from blood diseases such as coagulopathy;
  • Patients with a history of mental illness or active mental illness;
  • Have undergone major surgery within 6 months before enrollment;
  • A history of gastrointestinal, liver ,kidney diseases likely to influence drug absorption within 6 months before enrollment;
  • Drug or alcohol abuse;
  • History of drug abuse and drug use within 1 year prior to the study;
  • Habitual consumption of grapefruit juice, tea, coffee and/or caffeinated beverages, which cannot be withdrawn during the trial;
  • The average daily smoking volume is >5 within 3 months prior to the study;
  • A history of hypersensitivity and/or idiosyncrasy to any of the test compounds or related drugs or excipients employed in this study;
  • Participation in a clinical study within 3 months of the first dose of study drug;
  • Donation of blood within 3 months of the first dose of study drug or have a plan to donate blood;
  • Cannot be tolerant to oral drugs;
  • Poor peripheral venous access conditions;
  • The investigator believes that it should not be included;
  • Additional exclusion criteria apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03663686
Other Study ID Numbers  ICMJE HEC46877-P-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sunshine Lake Pharma Co., Ltd.
Study Sponsor  ICMJE Sunshine Lake Pharma Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xinghe Wang, MD Beijing Shijitan Hospital
PRS Account Sunshine Lake Pharma Co., Ltd.
Verification Date November 2018

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