Food Effect Study With BMS-955176
13. april 2017 opdateret af: ViiV Healthcare
An Open-Label, Randomized, Crossover Adaptive Design Study to Assess the Effect of Food on the Pharmacokinetics of BMS-955176 Administered as a Micronized Crystalline Tablet in Healthy Subjects
The purpose of this study is to assess the impact of a light meal, a standard meal, and a high fat meal on the PK of BMS-955176 MC tablet at a dose of 180 mg, relative to fasted conditions.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Primary Purpose
Other: This study will assess the impact of a light meal, a standard meal, and a high fat meal on the pharmacokinetics (PK) of BMS-955176 micronized crystalline (MC) tablet at a dose of 180 mg relative to fasted conditions.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
12
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Nottinghamshire
-
Ruddington Fields, Nottinghamshire, Det Forenede Kongerige, NG11 6JS
- GSK Investigational Site
-
-
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
Alle
Beskrivelse
Inclusion Criteria:
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead ECG measurements, and clinical laboratory test results
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = Weight (kg)/[Height (m)]2
- Men and women, ages 18 to 50 years, inclusive
- Women must not be of childbearing potential, must not be breastfeeding
Exclusion Criteria:
- Any significant acute or chronic medical illness
- History of cardiac disease or clinically significant cardiac arrhythmias
- Current or recent (within 3 months of study drug administration) gastrointestinal disease
- Any major surgery within 4 weeks of study drug administration
- Any gastrointestinal surgery (including cholecystectomy) that could impact upon the absorption of study drug
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm 1 (ABDC): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
|
Single dose by mouth for each treatment specified
|
|
Eksperimentel: Arm 2 (BCAD): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
|
Single dose by mouth for each treatment specified
|
|
Eksperimentel: Arm 3 (CDBA): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
|
Single dose by mouth for each treatment specified
|
|
Eksperimentel: Arm 4 (DACB): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
|
Single dose by mouth for each treatment specified
|
|
Eksperimentel: Arm 5 (EFHG): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
|
Single dose by mouth for each treatment specified
|
|
Eksperimentel: Arm 6 (FGEH): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
|
Single dose by mouth for each treatment specified
|
|
Eksperimentel: Arm 7 (GHFE): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
|
Single dose by mouth for each treatment specified
|
|
Eksperimentel: Arm 8 (HEGF): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
|
Single dose by mouth for each treatment specified
|
|
Eksperimentel: Arm 9 (IJK): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
|
Single dose by mouth for each treatment specified
|
|
Eksperimentel: Arm 10 (JKI): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
|
Single dose by mouth for each treatment specified
|
|
Eksperimentel: Arm 11 (KIJ): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
|
Single dose by mouth for each treatment specified
|
|
Eksperimentel: Arm 12 (IKJ): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
|
Single dose by mouth for each treatment specified
|
|
Eksperimentel: Arm 13 (JIK): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
|
Single dose by mouth for each treatment specified
|
|
Eksperimentel: Arm 14 (KJI): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
|
Single dose by mouth for each treatment specified
|
|
Eksperimentel: Arm 15 (LMN): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
|
Single dose by mouth for each treatment specified
|
|
Eksperimentel: Arm 16 (OPQ): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
|
Single dose by mouth for each treatment specified
|
|
Eksperimentel: Arm 17 (PQO): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
|
Single dose by mouth for each treatment specified
|
|
Eksperimentel: Arm 18 (QOP): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
|
Single dose by mouth for each treatment specified
|
|
Eksperimentel: Arm 19 (OQP): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
|
Single dose by mouth for each treatment specified
|
|
Eksperimentel: Arm 20 (POQ): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
|
Single dose by mouth for each treatment specified
|
|
Eksperimentel: Arm 21 (QPO): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
|
Single dose by mouth for each treatment specified
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Maximum observed plasma concentration (Cmax) for BMS-955176
Tidsramme: Up to Day 4 of Period 4
|
Up to Day 4 of Period 4
|
|
Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] for BMS-955176
Tidsramme: Up to Day 4 of Period 4
|
Up to Day 4 of Period 4
|
|
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-955176
Tidsramme: Up to Day 4 of Period 4
|
Up to Day 4 of Period 4
|
|
Plasma concentration at 24 hours post-dose (C24) for BMS-955176
Tidsramme: Up to Day 4 of Period 4
|
Up to Day 4 of Period 4
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Safety and tolerability
Tidsramme: Up to 30 days post discontinuation of dosing
|
Safety and tolerability measured by incidence of AEs, serious AEs (SAEs), AEs leading to discontinuation and death, marked abnormalities in clinical laboratory tests, viral sign measurements, ECGs, and physical examination Adverse Events (AEs), Electrocardiogram (ECG)
|
Up to 30 days post discontinuation of dosing
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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)
23. oktober 2014
Primær færdiggørelse (Faktiske)
15. august 2016
Studieafslutning (Faktiske)
15. august 2016
Datoer for studieregistrering
Først indsendt
10. oktober 2014
Først indsendt, der opfyldte QC-kriterier
23. oktober 2014
Først opslået (Skøn)
24. oktober 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. april 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. april 2017
Sidst verificeret
1. april 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Blodbårne infektioner
- Overførbare sygdomme
- Seksuelt overførte sygdomme, virale
- Seksuelt overførte sygdomme
- Lentivirus infektioner
- Retroviridae infektioner
- Immunologiske mangelsyndromer
- Sygdomme i immunsystemet
- Langsomme virussygdomme
- HIV-infektioner
- Erhvervet immundefektsyndrom
- Anti-infektionsmidler
- Antivirale midler
- Anti-HIV-midler
- Anti-retrovirale midler
- BMS-955176
Andre undersøgelses-id-numre
- 206221
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