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Succinate Salt Version of GSK961081 for Healthy Volunteers

28. september 2021 opdateret af: Theravance Biopharma

A Randomised, Double-blind, Dose Escalating Study in Healthy Volunteers to Assess the Safety, Tolerability, Extra Pulmonary Pharmacodynamics and Pharmacokinetics of Single Doses of GSK961081 (Succinate Salt)

Salt Bridging study for GSK961081

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

18

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 50 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • Healthy adult males or female aged between 18 and 50 years.
  • Body mass index within the range 19-29.9 kilograms/metre2
  • Forced Expiratory Volume in 1 second (FEV1) >80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio > 0.7
  • Subjects are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of < 10 pack years.

Exclusion criteria:

  • Who have a past or present disease, which as judged by the Investigator and medical monitor may affect the outcome of the study or the safety of the subject
  • History of respiratory disease
  • Significant abnormal 12 lead ECG, QTc(B) and QTc(F) value at screening >450msec on an individual ECG or a PR interval outside the range 120-210 msec
  • Supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
  • Subject has donated a unit of blood within the 56 days or intends to donate within 56 days after completing the study
  • Subject is currently taking regular (or course of) medication whether prescribed or not (with the exception of contraceptives, including vitamins and herbal remedies such as St John's Wort.
  • Subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 3 months
  • Infected with the Hepatitis B, Hepatitis C, or HIV virus
  • Subject has a history of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sequence 1
In session 1, subjects will receive 300 microgram GSK961081 succinate followed by placebo in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and 1500 micrograms of GSK961081 edisylate in session 4.
Medicin: GSK961081
GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams. GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms. The dose of GSK961081 edisylate is 1500 micrograms.
Medicin: GSK961081 matching placebo
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
Eksperimentel: Sequence 2
In session 1, subjects will receive 300 microgram GSK961081 succinate followed by 1500 micrograms of GSK961081 edisylate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and placebo in session 4.
Medicin: GSK961081
GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams. GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms. The dose of GSK961081 edisylate is 1500 micrograms.
Medicin: GSK961081 matching placebo
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
Eksperimentel: Sequence 3
In session 1, subjects will receive 300 microgram GSK961081 succinate followed by placebo in session 2. The subjects will receive 1500 micrograms of GSK961081edisylate in session 3 and an additional dose of GSK961081 succinate in session 4.
Medicin: GSK961081
GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams. GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms. The dose of GSK961081 edisylate is 1500 micrograms.
Medicin: GSK961081 matching placebo
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
Eksperimentel: Sequence 4
In session 1, subjects will receive 300 microgram GSK961081 succinate followed by 1500 micrograms of GSK961081 edisylate in session 2. The subjects will receive placebo in session 3 and an additional dose of GSK961081 succinate in session 4.
Medicin: GSK961081
GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams. GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms. The dose of GSK961081 edisylate is 1500 micrograms.
Medicin: GSK961081 matching placebo
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
Eksperimentel: Sequence 5
In session 1, subjects will receive 1500 micrograms of GSK961081 edisylate followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and placebo in session 4.
Medicin: GSK961081
GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams. GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms. The dose of GSK961081 edisylate is 1500 micrograms.
Medicin: GSK961081 matching placebo
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
Eksperimentel: Sequence 6
In session 1, subjects will receive placebo followed by 900 micrograms of GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and 1500 micrograms of GSK961081 edisylate in session 4.
Medicin: GSK961081
GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams. GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms. The dose of GSK961081 edisylate is 1500 micrograms.
Medicin: GSK961081 matching placebo
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
Eksperimentel: Sequence 7
In session 1, subjects will receive 1500 micrograms of GSK961081 edisylate followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive placebo in session 3 and an additional dose of GSK961081 succinate in session 4.
Medicin: GSK961081
GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams. GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms. The dose of GSK961081 edisylate is 1500 micrograms.
Medicin: GSK961081 matching placebo
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
Eksperimentel: Sequence 8
In session 1, subjects will receive placebo followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 edisylate in session 3 and an additional dose of GSK961081 succinate in session 4.
Medicin: GSK961081
GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams. GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms. The dose of GSK961081 edisylate is 1500 micrograms.
Medicin: GSK961081 matching placebo
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
FEV1 at intervals
Tidsramme: during the 10 week study
during the 10 week study
Cardiac monitoring at intervals
Tidsramme: during the 10 week study
during the 10 week study

Sekundære resultatmål

Resultatmål
Tidsramme
Plasma concentrations of GSK961081 at intervals
Tidsramme: during the 10 week study
during the 10 week study
PK parameters at intervals
Tidsramme: during the 10week study
during the 10week study

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Theravance Biopharma

Samarbejdspartnere

GlaxoSmithKline

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. november 2007

Primær færdiggørelse (Faktiske)

8. januar 2008

Studieafslutning (Faktiske)

8. januar 2008

Datoer for studieregistrering

Først indsendt

26. oktober 2007

Først indsendt, der opfyldte QC-kriterier

26. oktober 2007

Først opslået (Skøn)

29. oktober 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. oktober 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. september 2021

Sidst verificeret

1. september 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MAB108115

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Studiedata/dokumenter

  1. Individuelt deltagerdatasæt
    Informations-id: MAB108115
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Studieprotokol
    Informations-id: MAB108115
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Klinisk undersøgelsesrapport
    Informations-id: MAB108115
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistisk analyseplan
    Informations-id: MAB108115
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Datasætspecifikation
    Informations-id: MAB108115
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Annoteret sagsbetænkningsformular
    Informations-id: MAB108115
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Formular til informeret samtykke
    Informations-id: MAB108115
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med GSK961081

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Lebanon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner