Study to Evaluate the Safety, Pharmacokinetics and Tolerability of BMS-708163
18 novembre 2011 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
- Droga: BMS-708163 (Gamma-Secretase Inhibitor)
- Droga: BMS-708163 (Gamma-Secretase Inhibitor)
- Droga: BMS-708163 (Gamma-Secretase Inhibitor)
- Droga: BMS-708163 (Gamma-Secretase Inhibitor)
- Droga: BMS-708163 (Gamma-Secretase Inhibitor)
- Droga: BMS-708163 (Gamma-Secretase Inhibitor)
- Droga: BMS-708163 (Gamma-Secretase Inhibitor)
- Droga: BMS-708163 (Gamma-Secretase Inhibitor)
- Droga: BMS-708163 (Gamma-Secretase Inhibitor)
- Droga: BMS-708163 (Gamma-Secretase Inhibitor)
- Droga: Placebo matching BMS-708163
- Droga: Placebo matching BMS-708163
Tipo di studio
Interventistico
Iscrizione (Effettivo)
116
Fase
- Fase 1
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Safety and tolerability of Single doses of BMS-708163 in the range of 0.3 to 800 mg in the healthy subjects
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Effects of BMS-708163 on cortisol and QT interval corrected for heart rate
Lasso di tempo: 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
Lasso di tempo: Within 28 days of dosing
|
Within 28 days of dosing
|
|
Bioavailability of BMS-708163 from a capsule formulation relative to a solution formulation
Lasso di tempo: Within 28 days of dosing
|
Within 28 days of dosing
|
|
Effect of food on the PK of BMS-708163 administered as a capsule formulation
Lasso di tempo: Within 28 days of dosing
|
Within 28 days of dosing
|
|
Maximum observed plasma concentration (Cmax) of BMS-708163
Lasso di tempo: Within 28 days of dosing
|
Within 28 days of dosing
|
|
Time of maximum observed plasma concentration (Tmax) of BMS-708163
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Within 28 days of dosing
|
Within 28 days of dosing
|
|
Plasma half-life (T-HALF) of BMS-708163
Lasso di tempo: Within 28 days of dosing
|
Within 28 days of dosing
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 giugno 2007
Completamento primario (Effettivo)
1 marzo 2009
Completamento dello studio (Effettivo)
1 marzo 2009
Date di iscrizione allo studio
Primo inviato
7 ottobre 2011
Primo inviato che soddisfa i criteri di controllo qualità
17 ottobre 2011
Primo Inserito (Stima)
18 ottobre 2011
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
21 novembre 2011
Ultimo aggiornamento inviato che soddisfa i criteri QC
18 novembre 2011
Ultimo verificato
1 novembre 2011
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CN156-001
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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