The Safety, Tolerability and Pharmacokinetic Study of Litapiprant Tablets in Healthy Male and Female Subjects
Phase 1
Completed
- Conditions
- Asthma
- Interventions
- Drug: Litapiprant Tablet
- Registration Number
- NCT03663686
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description 25mg single doses Litapiprant Tablet Intervention Drug: 25mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily 400mg single doses Litapiprant Tablet Intervention Drug: 400mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily 800mg single doses Litapiprant Tablet Intervention Drug: 800mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily 50mg single doses Litapiprant Tablet Intervention Drug: 50mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily 200mg single doses Litapiprant Tablet Intervention Drug: 200mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily 600mg single doses Litapiprant Tablet Intervention Drug: 600mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily 100mg single doses Litapiprant Tablet Intervention Drug: 100mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
- Primary Outcome Measures
Name Time Method Adverse events Baseline to day 8~10 To assess the safety and tolerability after a single dose of Litapiprant Tablets
- Secondary Outcome Measures
Name Time Method AUC0-∞ 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
tmax 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
AUC0-t 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 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
Vz/F 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
t½ 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
Trial Locations
- Locations (1)
Beijing shijitan hospital
🇨🇳Beijing, Beijing, China