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

Sunshine Lake Pharma

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Litapiprant Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03663686

HEC46877-P-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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60 participants in 7 patient groups, including a placebo group

25mg single doses

Placebo Comparator group

Description:

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

Treatment:

Drug: Litapiprant Tablet

50mg single doses

Placebo Comparator group

Description:

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

Treatment:

Drug: Litapiprant Tablet

100mg single doses

Placebo Comparator group

Description:

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

Treatment:

Drug: Litapiprant Tablet

200mg single doses

Placebo Comparator group

Description:

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

Treatment:

Drug: Litapiprant Tablet

400mg single doses

Placebo Comparator group

Description:

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

Treatment:

Drug: Litapiprant Tablet

600mg single doses

Placebo Comparator group

Description:

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

Treatment:

Drug: Litapiprant Tablet

800mg single doses

Placebo Comparator group

Description:

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

Treatment:

Drug: Litapiprant Tablet