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

NCT03663686 | Completed Phase 1

• 1 other identifier: HEC46877-P-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Adverse events

  To assess the safety and tolerability after a single dose of Litapiprant Tablets

  Baseline to day 8~10

Secondary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

Study Arms (7)

25mg single doses

PLACEBO COMPARATOR

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

Drug: Litapiprant Tablet

50mg single doses

PLACEBO COMPARATOR

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

Drug: Litapiprant Tablet

100mg single doses

PLACEBO COMPARATOR

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

Drug: Litapiprant Tablet

200mg single doses

PLACEBO COMPARATOR

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

Drug: Litapiprant Tablet

400mg single doses

PLACEBO COMPARATOR

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

Drug: Litapiprant Tablet

600mg single doses

PLACEBO COMPARATOR

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

Drug: Litapiprant Tablet

800mg single doses

PLACEBO COMPARATOR

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

Drug: Litapiprant Tablet

Interventions

Litapiprant Tablet DRUG

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

100mg single doses; 200mg single doses; 25mg single doses; 400mg single doses; 50mg single doses; 600mg single doses; 800mg single doses

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

Beijing shijitan hospital

Beijing, Beijing Municipality, 100038, China

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Xinghe Wang, MD

  Beijing Shijitan Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2018
• First Posted: September 10, 2018
• Study Start: October 25, 2018
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: July 27, 2020

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)