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

23 luglio 2020 aggiornato da: Sunshine Lake Pharma Co., Ltd.

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

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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

60

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
    • Beijing
      • Beijing, Beijing, Cina, 100038
        • Beijing Shijitan Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 45 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: 25mg single doses
Intervention Drug: 25mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
Droga: Litapiprant Tablet
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
Comparatore placebo: 50mg single doses
Intervention Drug: 50mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
Droga: Litapiprant Tablet
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
Comparatore placebo: 100mg single doses
Intervention Drug: 100mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
Droga: Litapiprant Tablet
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
Comparatore placebo: 200mg single doses
Intervention Drug: 200mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
Droga: Litapiprant Tablet
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
Comparatore placebo: 400mg single doses
Intervention Drug: 400mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
Droga: Litapiprant Tablet
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
Comparatore placebo: 600mg single doses
Intervention Drug: 600mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
Droga: Litapiprant Tablet
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
Comparatore placebo: 800mg single doses
Intervention Drug: 800mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
Droga: Litapiprant Tablet
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adverse events
Lasso di tempo: Baseline to day 8~10
To assess the safety and tolerability after a single dose of Litapiprant Tablets
Baseline to day 8~10

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
AUC0-∞
Lasso di tempo: 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
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
AUC0-t
Lasso di tempo: 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
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
Cmax
Lasso di tempo: 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
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
tmax
Lasso di tempo: 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
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
t½
Lasso di tempo: 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
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
Vz/F
Lasso di tempo: 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
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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sunshine Lake Pharma Co., Ltd.

Investigatori

  • Investigatore principale: Xinghe Wang, MD, Beijing Shijitan Hospital, Capital Medical University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

25 ottobre 2018

Completamento primario (Effettivo)

30 gennaio 2019

Completamento dello studio (Effettivo)

30 gennaio 2019

Date di iscrizione allo studio

Primo inviato

2 settembre 2018

Primo inviato che soddisfa i criteri di controllo qualità

6 settembre 2018

Primo Inserito (Effettivo)

10 settembre 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 luglio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 luglio 2020

Ultimo verificato

1 novembre 2018

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • HEC46877-P-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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