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

NCT ID: NCT03663686

Last Updated: 2020-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-25
• Study Completion Date: 2019-01-30

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

25mg single doses

Intervention Drug: 25mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily

Group Type: PLACEBO_COMPARATOR

Litapiprant Tablet

Intervention Type: DRUG

Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells

50mg single doses

Intervention Drug: 50mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily

Group Type: PLACEBO_COMPARATOR

Litapiprant Tablet

Intervention Type: DRUG

Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells

100mg single doses

Intervention Drug: 100mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily

Group Type: PLACEBO_COMPARATOR

Litapiprant Tablet

Intervention Type: DRUG

Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells

200mg single doses

Intervention Drug: 200mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily

Group Type: PLACEBO_COMPARATOR

Litapiprant Tablet

Intervention Type: DRUG

Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells

400mg single doses

Intervention Drug: 400mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily

Group Type: PLACEBO_COMPARATOR

Litapiprant Tablet

Intervention Type: DRUG

Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells

600mg single doses

Intervention Drug: 600mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily

Group Type: PLACEBO_COMPARATOR

Litapiprant Tablet

Intervention Type: DRUG

Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells

800mg single doses

Intervention Drug: 800mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily

Group Type: PLACEBO_COMPARATOR

Litapiprant Tablet

Intervention Type: DRUG

Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells

Interventions

Litapiprant Tablet

Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells

Intervention Type: DRUG

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunshine Lake Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xinghe Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Shijitan Hospital, Capital Medical University

Locations

Beijing shijitan hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

HEC46877-P-01

Identifier Type: -

Identifier Source: org_study_id