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A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin - Summary Telemetry Abnormalities V12 6-DF

- 10/08/2020 - 1 Formulaire, 1 Groupe Item, 80 Eléments de données, 1 Langue
Groupe Item: Summary Telemetry Abnormalities
The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitis Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin - Summary Telemetry Abnormalities V4 11-DF

- 10/08/2020 - 1 Formulaire, 1 Groupe Item, 80 Eléments de données, 1 Langue
Groupe Item: Summary Telemetry Abnormalities
The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitis Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin - Summary Telemetry Abnormalities V2 21-DF

- 10/08/2020 - 1 Formulaire, 1 Groupe Item, 80 Eléments de données, 1 Langue
Groupe Item: Summary Telemetry Abnormalities
The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitis Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin - Summary Telemetry Abnormalities V10 10-DF

- 10/08/2020 - 1 Formulaire, 1 Groupe Item, 80 Eléments de données, 1 Langue
Groupe Item: Summary Telemetry Abnormalities
The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitis Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin - Summary Telemetry Abnormalities V6 14-DF

- 10/08/2020 - 1 Formulaire, 1 Groupe Item, 80 Eléments de données, 1 Langue
Groupe Item: Summary Telemetry Abnormalities
The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitis Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin - Summary Telemetry Abnormalities V8 12-DF

- 10/08/2020 - 1 Formulaire, 1 Groupe Item, 80 Eléments de données, 1 Langue
Groupe Item: Summary Telemetry Abnormalities
The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitis Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin - Pharmacodynamics - (mOGTT - Blood) V4 8-DF

- 07/06/2020 - 1 Formulaire, 10 Groupes Item, 10 Eléments de données, 1 Langue
Groupes Item: Glucose admin date and time, 10 minutes pre-glucose, Pre-glucose, 10 minutes post, 20 minutes post, 30 minutes post, 60 minutes post, 90 minutes post, 120 minutes post, 180 minutes post
The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitis Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin - Pharmacodynamics - (mOGTT - Blood) V8 9-DF

- 07/06/2020 - 1 Formulaire, 10 Groupes Item, 10 Eléments de données, 1 Langue
Groupes Item: Glucose admin date and time, 10 minutes pre-glucose, Pre-glucose, 10 minutes post, 20 minutes post, 30 minutes post, 60 minutes post, 90 minutes post, 120 minutes post, 180 minutes post
The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitis Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin - Pharmacodynamics - (mOGTT - Blood) V6 11-DF

- 07/06/2020 - 1 Formulaire, 10 Groupes Item, 10 Eléments de données, 1 Langue
Groupes Item: Glucose admin date and time, 10 minutes pre-glucose, Pre-glucose, 10 minutes post, 20 minutes post, 30 minutes post, 60 minutes post, 90 minutes post, 120 minutes post, 180 minutes post
The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitis Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin - Pharmacodynamics - (mOGTT - Blood) V2 15-DF

- 07/06/2020 - 1 Formulaire, 10 Groupes Item, 10 Eléments de données, 1 Langue
Groupes Item: Glucose admin date and time, 10 minutes pre-glucose, Pre-glucose, 10 minutes post, 20 minutes post, 30 minutes post, 60 minutes post, 90 minutes post, 120 minutes post, 180 minutes post
The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitis Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

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