Study to Evaluate the Safety, Pharmacokinetics and Tolerability of BMS-708163
18 november 2011 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
- Geneesmiddel: BMS-708163 (Gamma-Secretase Inhibitor)
- Geneesmiddel: BMS-708163 (Gamma-Secretase Inhibitor)
- Geneesmiddel: BMS-708163 (Gamma-Secretase Inhibitor)
- Geneesmiddel: BMS-708163 (Gamma-Secretase Inhibitor)
- Geneesmiddel: BMS-708163 (Gamma-Secretase Inhibitor)
- Geneesmiddel: BMS-708163 (Gamma-Secretase Inhibitor)
- Geneesmiddel: BMS-708163 (Gamma-Secretase Inhibitor)
- Geneesmiddel: BMS-708163 (Gamma-Secretase Inhibitor)
- Geneesmiddel: BMS-708163 (Gamma-Secretase Inhibitor)
- Geneesmiddel: BMS-708163 (Gamma-Secretase Inhibitor)
- Geneesmiddel: Placebo matching BMS-708163
- Geneesmiddel: Placebo matching BMS-708163
Studietype
Ingrijpend
Inschrijving (Werkelijk)
116
Fase
- Fase 1
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Safety and tolerability of Single doses of BMS-708163 in the range of 0.3 to 800 mg in the healthy subjects
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Effects of BMS-708163 on cortisol and QT interval corrected for heart rate
Tijdsspanne: 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
Tijdsspanne: Within 28 days of dosing
|
Within 28 days of dosing
|
|
Bioavailability of BMS-708163 from a capsule formulation relative to a solution formulation
Tijdsspanne: Within 28 days of dosing
|
Within 28 days of dosing
|
|
Effect of food on the PK of BMS-708163 administered as a capsule formulation
Tijdsspanne: Within 28 days of dosing
|
Within 28 days of dosing
|
|
Maximum observed plasma concentration (Cmax) of BMS-708163
Tijdsspanne: Within 28 days of dosing
|
Within 28 days of dosing
|
|
Time of maximum observed plasma concentration (Tmax) of BMS-708163
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Within 28 days of dosing
|
Within 28 days of dosing
|
|
Plasma half-life (T-HALF) of BMS-708163
Tijdsspanne: Within 28 days of dosing
|
Within 28 days of dosing
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juni 2007
Primaire voltooiing (Werkelijk)
1 maart 2009
Studie voltooiing (Werkelijk)
1 maart 2009
Studieregistratiedata
Eerst ingediend
7 oktober 2011
Eerst ingediend dat voldeed aan de QC-criteria
17 oktober 2011
Eerst geplaatst (Schatting)
18 oktober 2011
Updates van studierecords
Laatste update geplaatst (Schatting)
21 november 2011
Laatste update ingediend die voldeed aan QC-criteria
18 november 2011
Laatst geverifieerd
1 november 2011
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CN156-001
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .