- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00424034
A Study of GSK1325760A in Healthy Japanese Subjects
18. januar 2017 oppdatert av: GlaxoSmithKline
Phase I Study of Ambrisentan - Single Dose Study in Healthy Japanese Male Subjects
To investigate the safety, tolerability, pharmacokinetics and the effect of food on pharmacokinetics after single oral administrations of GSK1325760A
Studieoversikt
Detaljert beskrivelse
Phase1 study of GSK1325760A
- A double blind, single center, randomised, placebo-controlled, partially crossover, single dose study to investigate the safety, tolerability, pharmacokinetics and to assess the effect of food on pharmacokinetics of ascending oral doses of GSK1325760A in healthy Japanese male subject -
Studietype
Intervensjonell
Registrering (Faktiske)
32
Fase
- Fase 1
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
20 år til 64 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- They are considered as healthy by the investigator at screening. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, clinical laboratory tests, vital sign, 12-lead ECG, immunology tests and urinary drug screening tests.
- They are Japanese males.
- Aged 20 to 64 years, inclusive.
- They have a body mass index (weight/height2) at screening in the range of 18.5 and <25.0 kg/m2 inclusive. Standard weight is in the range of 55-85 kg inclusive.
- Blood pressure and pulse rate at screening within the normal range (systolic 90-140 mmHg, diastolic 40-90 mmHg, pulse rate 40-90bpm).
- They have the following clinical laboratory test
- Biochemistry (AST(GOT), ALT(GPT), ALP, LDH and gamma-GTP : within normal range at screening.
- Haematology (RBC, Hb and Ht) below upper limit normal range at screening.
- Normal ECG at screening (QTc value of <440msec).
- They give their consent to be able to abstain from sexual intercourse or use condom for contraception from at screening until post-study screen.
- They are capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- They are non-smokers (at least 6 months).
- They are able to attend all visits and complete the study.
Exclusion Criteria:
- The subject has any clinically relevant abnormality on medical examination, vital sign, clinical laboratory test or medical history at screening in the medical opinion of the investigator or the subject has a medical history that is not considered as eligible for inclusion in this study by the investigator.
- The subject has an allergy for any drug or idiosyncrasy. This excludes a pollen allergy without current symptoms.
- The subject has participated in a clinical study or post-marketing study with an investigational or a non-investigational product or device during the previous 4 months of the first dosing.
- The subject is concurrently participating in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational product or device.
- The subject is positive for syphilis, HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody.
- The subject is positive for urine drugs of abuse test.
- The subject has donated a unit of blood (>400mL) within the previous 4 months or (>200mL) within the previous 1 month of screening.
- The subject is currently taking regular (or a course of) medication (including prescribed drug, over-the-counter medication and herbal preparations). Medication nor permitted during the study must be discontinued 14 days prior to dosing.
- The subject has a history or current conditions of drug abuse or alcoholism according to ICD10.
- The subject has a history of regular alcohol consumption exceeding 7 drinks/week (1 drink = 350mL of beer) within 6 months of the first dosing.
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: Parallell tildeling
- Masking: Dobbelt
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Adverse events Change in Clinical laboratory test Vital sign 12-lead ECG Plasma concentration Urine concentration
Tidsramme: on 5 or 6 days after dosing
|
on 5 or 6 days after dosing
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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
1. januar 2007
Primær fullføring (Faktiske)
1. februar 2007
Studiet fullført (Faktiske)
1. februar 2007
Datoer for studieregistrering
Først innsendt
16. januar 2007
Først innsendt som oppfylte QC-kriteriene
17. januar 2007
Først lagt ut (Anslag)
18. januar 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
19. januar 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. januar 2017
Sist bekreftet
1. januar 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AMB107623
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .