Clinical trial NCT03663686: The Safety, Tolerability and Pharmacokinetic Study of Litapiprant Tablets in Healthy Male and Female Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-09-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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;
* Additional exclusion criteria apply.

Primary outcomes:
measure: Adverse events
timeFrame: Baseline to day 8~10
Secondary outcomes:
measure: AUC0-∞
timeFrame: 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
measure: AUC0-t
timeFrame: 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
measure: Cmax
timeFrame: 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
measure: tmax
timeFrame: 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
measure: t½
timeFrame: 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
measure: Vz/F
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing shijitan hospital
state: Beijing
Study officials:
affiliation: Beijing Shijitan Hospital, Capital Medical University
name: Xinghe Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: