Study to Evaluate the Safety, Pharmacokinetics and Tolerability of BMS-708163
18. november 2011 opdateret af: Bristol-Myers Squibb
Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-708163 in Healthy Male Subjects and a Comparison to Elderly Male and Female Subjects
The primary objective is to assess the safety and tolerability of a single oral dose of BMS-708163 in healthy young male subjects and in elderly male and female subjects.
Studieoversigt
Status
Status
Afsluttet
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
- Medicin: BMS-708163 (Gamma-Secretase Inhibitor)
- Medicin: BMS-708163 (Gamma-Secretase Inhibitor)
- Medicin: BMS-708163 (Gamma-Secretase Inhibitor)
- Medicin: BMS-708163 (Gamma-Secretase Inhibitor)
- Medicin: BMS-708163 (Gamma-Secretase Inhibitor)
- Medicin: BMS-708163 (Gamma-Secretase Inhibitor)
- Medicin: BMS-708163 (Gamma-Secretase Inhibitor)
- Medicin: BMS-708163 (Gamma-Secretase Inhibitor)
- Medicin: BMS-708163 (Gamma-Secretase Inhibitor)
- Medicin: BMS-708163 (Gamma-Secretase Inhibitor)
- Medicin: Placebo matching BMS-708163
- Medicin: Placebo matching BMS-708163
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
116
Fase
Fase
- Fase 1
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
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Panels 1- 8 and Panels 14-15: healthy male subjects between the ages of 18 to 45
- Panels 9 and 10: healthy elderly males and females ages 60 and greater
- Panel 11: healthy males between the ages of 46-59
- Panel 12: males and/or females either healthy or with mild cognitive impairment (MCI) between the ages of 60 and 74
- Panel 13: males and/or females, healthy or with Alzheimer's disease (AD) or MCI that were 75 years of age or greater
- Acceptable medical history, physical examinations, vital signs, electrocardiograms, hemoccult stool tests, and clinical laboratory evaluations
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Antal våben
14
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Panel 1: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
Eksperimentel: Panel 2: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
Eksperimentel: Panel 3: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
Eksperimentel: Panel 4: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
Eksperimentel: Panel 5: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years). In Period 2: Subjects will receive BMS-708163 or placebo as a capsule formulation. In Period 3: Subjects will receive BMS-708163 or placebo as a capsule formulation within 5 minutes of consuming a standard high-fat breakfast on Day 1 |
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
Eksperimentel: Panel 6: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
Eksperimentel: Panel 7: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
Eksperimentel: Panel 8: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
Eksperimentel: Panel 9: BMS-708163 or Placebo
Healthy, elderly male subjects (age: 60 years and greater)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
Eksperimentel: Panel 10: BMS-708163 or Placebo
Healthy, elderly female subjects (age: 60 years and greater)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
Eksperimentel: Panel 11: BMS-708163 or Placebo
Healthy male subjects (age: between 46 to 59 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
Eksperimentel: Panel 12: BMS-708163 or Placebo
Healthy male and/or female subjects or subjects with MCI (age: between 60-74 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
Eksperimentel: Panel 13: BMS-708163 or Placebo
Healthy male and/or female subjects or with AD or MCI (age: 75 years or greater)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
Eksperimentel: Panel 15: BMS-708163 or Placebo
Healthy young male subjects
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Safety and tolerability of Single doses of BMS-708163 in the range of 0.3 to 800 mg in the healthy subjects
Tidsramme: Within 28 days of dosing
|
Based on adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
|
Within 28 days of dosing
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Effects of BMS-708163 on cortisol and QT interval corrected for heart rate
Tidsramme: Within 28 days of dosing
|
Within 28 days of dosing
|
|
Effect of BMS-708163 on thyroid stimulating hormone (TSH), free triiodothyronine (T3), free thyroxine (T4), and lymphocyte subsets
Tidsramme: Within 28 days of dosing
|
Within 28 days of dosing
|
|
Bioavailability of BMS-708163 from a capsule formulation relative to a solution formulation
Tidsramme: Within 28 days of dosing
|
Within 28 days of dosing
|
|
Effect of food on the PK of BMS-708163 administered as a capsule formulation
Tidsramme: Within 28 days of dosing
|
Within 28 days of dosing
|
|
Maximum observed plasma concentration (Cmax) of BMS-708163
Tidsramme: Within 28 days of dosing
|
Within 28 days of dosing
|
|
Time of maximum observed plasma concentration (Tmax) of BMS-708163
Tidsramme: Within 28 days of dosing
|
Within 28 days of dosing
|
|
Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-708163
Tidsramme: Within 28 days of dosing
|
Within 28 days of dosing
|
|
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-708163
Tidsramme: Within 28 days of dosing
|
Within 28 days of dosing
|
|
Plasma half-life (T-HALF) of BMS-708163
Tidsramme: Within 28 days of dosing
|
Within 28 days of dosing
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
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.
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
Studiestart
1. juni 2007
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
1. marts 2009
Studieafslutning (Faktiske)
Studieafslutning
1. marts 2009
Datoer for studieregistrering
Først indsendt
Først indsendt
7. oktober 2011
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
17. oktober 2011
Først opslået (Skøn)
Først opslået
18. oktober 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering sendt
21. november 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. november 2011
Sidst verificeret
Sidst verificeret
1. november 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- CN156-001
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 .