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A Single Dose Study to Investigate the Pharmacokinetics of MK-0941 in Participants With Renal Insufficiency (MK-0941-015-02)

9 febbraio 2015 aggiornato da: Merck Sharp & Dohme LLC

A Single Dose Study to Investigate the Pharmacokinetics of MK-0941 in Subjects With Renal Insufficiency

This study will assess the pharmacokinetics of MK-0941 in participants with varying degrees of renal insufficiency.

Panoramica dello studio

Stato

Terminato

Condizioni

Diabete di tipo 2

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

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

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

Male or nonpregnant female age 18 to 75 years
Female of childbearing potential on appropriate method of contraception
Body mass index (BMI) less than or equal to 40 kg/m2
Participant is in good health
Participant diagnosed with Type 2 Diabetes
Participant agrees to follow smoking restrictions
Willing to follow the study diet restrictions

Exclusion Criteria:

Mental or legal incapacitation
Participant has had kidney removed
History of Type 1 diabetes
History of stroke, chronic seizures or major neurological disorder
History of neoplastic disease
Nursing mother
Consumes greater than 4 glasses of alcoholic beverages per day
Consumes greater than 6 servings of caffeinated beverages per day
Participant has had surgery or donated 1 unit of blood within 1 month of screening
Participant has history of recent eye infection within 2 weeks of study drug administration
Clinically diagnosed with glaucoma or blindness
Has trauma to one or both eyes

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: Trattamento
Assegnazione: Non randomizzato
Modello interventistico: Assegnazione di gruppo singolo
Mascheramento: Nessuno (etichetta aperta)

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Sperimentale: MK-0941 20 mg Mild Renal Insufficiency MK-0941 20 mg administered to participants with mild renal insufficiency and type 2 diabetes.	Droga: MK-0941 20 mg Two 10-mg tablets of MK-0941 administered as a single oral dose.
Sperimentale: MK-0941 20 mg Moderate Renal Insufficiency MK-0941 20 mg administered to participants with moderate renal insufficiency and type 2 diabetes.	Droga: MK-0941 20 mg Two 10-mg tablets of MK-0941 administered as a single oral dose.
Sperimentale: MK-0941 5 mg Severe Renal Insufficiency MK-0941 5 mg administered to participants with severe renal insufficiency and type 2 diabetes.	Droga: MK-0941 5 mg MK-0941 administered as one single 5-mg tablet.
Sperimentale: MK-0941 20 mg Matched Controls MK-0941 20 mg administered to age-, gender-, race-, body mass index (BMI)-, and hemoglobin A1C (HbAIc)-matched control subjects with normal renal function and type 2 diabetes.	Droga: MK-0941 20 mg Two 10-mg tablets of MK-0941 administered as a single oral dose.
Sperimentale: MK-0941 5 mg Matched Controls MK-0941 5 mg administered to age-, gender-, race-, body mass index (BMI)-, and HbAIc-matched control subjects with normal renal function and type 2 diabetes.	Droga: MK-0941 5 mg MK-0941 administered as one single 5-mg tablet.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Plasma Area Under the Curve (AUC [0-infinity]) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls Lasso di tempo: 72 Hours Post-Dose	Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency taking a single oral dose of 20 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour creatinine clearance (CLCR) of > 50 to 80 mL/min/1.73m^2.	72 Hours Post-Dose
Plasma AUC (0-infinity) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among With Moderate Renal Insufficiency vs Matched Controls Lasso di tempo: 72-Hours Post-Dose	Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency taking a single oral dose of 20 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.	72-Hours Post-Dose
Plasma AUC (0-infinity) After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls Lasso di tempo: 72-Hours Post-Dose	Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency taking a single oral dose of 5 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.	72-Hours Post-Dose

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Maximum Plasma Concentration (Cmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls Lasso di tempo: 72-Hours Post-Dose	Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.	72-Hours Post-Dose
Cmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls Lasso di tempo: 72-Hours Post-Dose	Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.	72-Hours Post-Dose
Cmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls Lasso di tempo: 72-Hours Post-Dose	Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.	72-Hours Post-Dose
Time to Maximum Plasma Concentration (Tmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls Lasso di tempo: 72-Hours Post-Dose	Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.	72-Hours Post-Dose
Tmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls Lasso di tempo: 72-Hours Post-Dose	Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.	72-Hours Post-Dose
Tmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls Lasso di tempo: 72-Hours Post-Dose	Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.	72-Hours Post-Dose
Time to Apparent Half Life (T 1/2) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls Lasso di tempo: 72-Hours Post-Dose	T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.	72-Hours Post-Dose
T 1/2 After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls Lasso di tempo: 72-Hours Post-Dose	T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.	72-Hours Post-Dose
T 1/2 After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls Lasso di tempo: 72-Hours Post-Dose	T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.	72-Hours Post-Dose
Amount of MK-0941 Excreted Unchanged in the Urine (Fe) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency Versus Matched Controls Lasso di tempo: 36-Hours Post-Dose	Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.	36-Hours Post-Dose
Fe After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency Versus Matched Controls Lasso di tempo: 36-Hours Post-Dose	Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.	36-Hours Post-Dose
Fe After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency Versus Matched Controls Lasso di tempo: 36-Hours Post-Dose	Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 5 mg of MK-0941 versus controls with normal renal function that received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of < 30 mL/min/1.73m^2.	36-Hours Post-Dose
CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls Lasso di tempo: 36-Hours Post-Dose	CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.	36-Hours Post-Dose
CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls Lasso di tempo: 36-Hours Post-Dose	CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.	36-Hours Post-Dose
CLCR After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls Lasso di tempo: 36-Hours Post-Dose	CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency that received 5 mg of MK-0941 versus controls with normal renal function that received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of < 30 mL/min/1.73m^2.	36-Hours Post-Dose
Plasma Glucose Concentration After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls Lasso di tempo: Up to 12 Hours Post-Dose	The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.	Up to 12 Hours Post-Dose
Plasma Glucose Concentration After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls Lasso di tempo: Up to 12 Hours Post-Dose	The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to < 50 mL/min/1.73m^2.	Up to 12 Hours Post-Dose
Plasma Glucose Concentration After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls Lasso di tempo: Up to 12 Hours Post-Dose	The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of < 30 mL/min/1.73m^2.	Up to 12 Hours Post-Dose

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Merck Sharp & Dohme LLC

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 gennaio 2009

Completamento primario (Effettivo)

1 settembre 2009

Completamento dello studio (Effettivo)

1 settembre 2009

Date di iscrizione allo studio

Primo inviato

26 gennaio 2009

Primo inviato che soddisfa i criteri di controllo qualità

26 gennaio 2009

Primo Inserito (Stima)

28 gennaio 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

26 febbraio 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 febbraio 2015

Ultimo verificato

1 febbraio 2015

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

0941-015
2009_522

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

prodotto fabbricato ed esportato dagli Stati Uniti

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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A Single Dose Study to Investigate the Pharmacokinetics of MK-0941 in Participants With Renal Insufficiency (MK-0941-015-02)

A Single Dose Study to Investigate the Pharmacokinetics of MK-0941 in Subjects With Renal Insufficiency

Panoramica dello studio

Stato

Condizioni

Intervento / Trattamento

Tipo di studio

Iscrizione (Effettivo)

Fase

Criteri di partecipazione

Criteri di ammissibilità

Età idonea allo studio

Accetta volontari sani

Sessi ammissibili allo studio

Descrizione

Piano di studio

Come è strutturato lo studio?

Dettagli di progettazione

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm

Intervento / Trattamento

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Misure di risultato secondarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Collaboratori e investigatori

Sponsor

Studiare le date dei record

Studia le date principali

Inizio studio

Completamento primario (Effettivo)

Completamento dello studio (Effettivo)

Date di iscrizione allo studio

Primo inviato

Primo inviato che soddisfa i criteri di controllo qualità

Primo Inserito (Stima)

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo verificato

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

prodotto fabbricato ed esportato dagli Stati Uniti

Prove cliniche su Diabete di tipo 2

Prove cliniche su MK-0941 20 mg

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Bahrain

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi