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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03663686
• Other study ID #: HEC46877-P-01
• Status: Completed
• Phase: Phase 1
• Start date: October 25, 2018
• Est. completion date: January 30, 2019

Study information

• Verified date: November 2018
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Litapiprant Tablet
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells

Locations

Country	Name	City	State
China	Beijing shijitan hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	To assess the safety and tolerability after a single dose of Litapiprant Tablets	Baseline to day 8~10
Secondary	AUC0-8	area under the concentration versus time curve (AUC) from time zero to infinity	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
Secondary	AUC0-t	AUC from time zero to the time of the last quantifiable concentration time zero to the time of the last quantifiable concentration	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
Secondary	Cmax	maximum observed plasma concentration	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
Secondary	tmax	time of the maximum observed plasma concentration	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
Secondary	t½	apparent terminal elimination half-life	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
Secondary	Vz/F	apparent volume of distribution	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