The Safety, Tolerability and Pharmacokinetic Study of Litapiprant Tablets in Healthy Male and Female Subjects
23. juli 2020 oppdatert av: 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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
60
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Beijing
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Beijing, Beijing, Kina, 100038
- Beijing Shijitan Hospital
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 45 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: 25mg single doses
Intervention Drug: 25mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
|
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
|
|
Placebo komparator: 50mg single doses
Intervention Drug: 50mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
|
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
|
|
Placebo komparator: 100mg single doses
Intervention Drug: 100mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
|
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
|
|
Placebo komparator: 200mg single doses
Intervention Drug: 200mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
|
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
|
|
Placebo komparator: 400mg single doses
Intervention Drug: 400mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
|
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
|
|
Placebo komparator: 600mg single doses
Intervention Drug: 600mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
|
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
|
|
Placebo komparator: 800mg single doses
Intervention Drug: 800mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily
|
Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Adverse events
Tidsramme: Baseline to day 8~10
|
To assess the safety and tolerability after a single dose of Litapiprant Tablets
|
Baseline to day 8~10
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
AUC0-∞
Tidsramme: 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
Tidsramme: 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
|
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Cmax
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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Vz/F
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Xinghe Wang, MD, Beijing Shijitan Hospital, Capital Medical University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
25. oktober 2018
Primær fullføring (Faktiske)
30. januar 2019
Studiet fullført (Faktiske)
30. januar 2019
Datoer for studieregistrering
Først innsendt
2. september 2018
Først innsendt som oppfylte QC-kriteriene
6. september 2018
Først lagt ut (Faktiske)
10. september 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. juli 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. juli 2020
Sist bekreftet
1. november 2018
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- HEC46877-P-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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Bhavya Bhavya, MDHar ikke rekruttert ennå