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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663686
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Sunshine Lake Pharma Co., Ltd.

Brief Summary:
The Safety, Tolerability and Pharmacokinetic Study of Asthma Treatment Drug Litapiprant Tablets in Healthy Male and Female subjects.

Condition or disease Intervention/treatment Phase
Asthma Drug: Litapiprant Tablet Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 29, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Placebo Comparator: 25mg single doses
Intervention Drug: 25mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
Drug: Litapiprant Tablet
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells

Placebo Comparator: 50mg single doses
Intervention Drug: 50mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
Drug: Litapiprant Tablet
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells

Placebo Comparator: 100mg single doses
Intervention Drug: 100mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
Drug: Litapiprant Tablet
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells

Placebo Comparator: 200mg single doses
Intervention Drug: 200mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
Drug: Litapiprant Tablet
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells

Placebo Comparator: 400mg single doses
Intervention Drug: 400mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
Drug: Litapiprant Tablet
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells

Placebo Comparator: 600mg single doses
Intervention Drug: 600mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
Drug: Litapiprant Tablet
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells

Placebo Comparator: 800mg single doses
Intervention Drug: 800mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
Drug: Litapiprant Tablet
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells




Primary Outcome Measures :
  1. Adverse events [ Time Frame: Baseline to day 8~10 ]
    To assess the safety and tolerability after a single dose of Litapiprant Tablets


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03663686


Contacts
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Contact: Xinghe Wang, MD 10-63926401 wangxh@bjsjth.cn

Locations
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China, Beijing
Beijing shijitan hospital Recruiting
Beijing, Beijing, China, 100038
Contact: xinghe Wang, M.D         
Sponsors and Collaborators
Sunshine Lake Pharma Co., Ltd.
Investigators
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Principal Investigator: Xinghe Wang, MD Beijing Shijitan Hospital
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Responsible Party: Sunshine Lake Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT03663686    
Other Study ID Numbers: HEC46877-P-01
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No