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Darapladib Evaluation Case Report Form GSK LPL107988 - Investigational Product

- 15-09-19 - 12 Formulär, 4 Item-grupper, 10 Dataelement, 1 Språk
Item-grupper: Administrative documentation, Randomisation Number, Investigational Product Exposure, Treatment Confirmation
Two-Part Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of Repeat Oral Dosesof the Enteric-Coated Free Base Formulation of Darapladib (SB-480848) ina Dose Rising Fashion and to Evaluate the Safety, Tolerability and Pharmacokinetics of Darapladib when Co-administered with Ketoconazole in Healthy Adult Subjects. There are 4 parts to this study: Screening, Part A, Part B, and Follow-Up. Part A contains 2 Sessions per day for day 1-10, Part B contains 1 Session per day for day 1-14. Each itemgroup contains information when it should be filled out. The itemgroups of the non-serious and serious adverse event forms contain additional information on the definition of a serious/non-serious adverse event.

Study Conclusion

5 Item-grupper 23 Dataelement

Laboratory Results

4 Item-grupper 7 Dataelement

Eligibility Criteria

4 Item-grupper 23 Dataelement

Concomitant Medication

3 Item-grupper 13 Dataelement

Non-serious adverse events

3 Item-grupper 12 Dataelement

ECG

5 Item-grupper 19 Dataelement

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Screen - Date of Visit; Demography, 12-Lead ECG; Vital Signs; Subject Identification; Electronically Transferred Lab Data

- 14-08-19 - 1 Formulär, 8 Item-grupper, 34 Dataelement, 1 Språk
Item-grupper: Inform Screening, Subject number, Date of Visit/ Assessment, Demography, 12-Lead ECG, Vital Signs, Subject identification, Electronically Transferred Lab Data
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Liver Event - Liver Events; Investigational Product; Pharmacokinetics; Medical Conditions; Alcohol Intake; Liver Imaging; Liver Biopsy

- 08-05-19 - 1 Formulär, 13 Item-grupper, 104 Dataelement, 1 Språk
Item-grupper: Date of Visit, Liver Event Assessment, Liver Events, Investigational Product (Liver) - during treatment period, Investigational Product (Liver) - after treatment period , Pharmacokinetics (Liver PK), Medical Conditions (Liver), Drug related liver disease conditions, Other liver disease conditions, Other medical conditions, Alcohol intake, Liver imaging, Liver Biopsy
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Pharmacogenetics - Pharmacogenetic Research Consent; Pharmacogenetics Research Withdrawal of Consent

- 06-05-19 - 1 Formulär, 2 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: Pharmacogenetic Research Consent, Withdrawal of consent for PGx (DNA) sample destruction
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Logs/ Repeats - Logs and Repeats; Non- Serious Adverse Events; Serious Adverse Events; Concomitant Medication; Electronically Transferred Lab Data; Vital Signs; 12-Lead ECG; ECG Abnormalities; Repeat- Pharmacokinetics Blood - GW856553

- 01-05-19 - 1 Formulär, 16 Item-grupper, 137 Dataelement, 1 Språk
Item-grupper: Logs ad Repeats, Logs and Repeats - Adverse event/ Concomitant Medication/ Repeat Assessment Check Questions, Non-serious Adverse Event (AE), Serious Adverse Events (SAE), Serious Adverse Event - Concomitant Medication, Serious Adverse Event - Medical Conditions/ Risk Factors, Serious Adverse Events - Relevant diagnostic results, Serious Adverse Events - Investigational Products, Serious Adverse Events - General narrative comments, Serious Adverse Events - Non clinical, Concomitant Medication, Electronically Transferred Lab Data, Vital signs, 12-Lead ECG, ECG Abnormalities, Repeat Pharmacokinetics Blood - GW856553
Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosi

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Period 1 - Randomisation Number; 12-Lead ECG; Vital Signs; Pharmacokinetics Blood GW856553; Electronically Transferred Lab Data; Investigational Product

- 23-04-19 - 1 Formulär, 17 Item-grupper, 106 Dataelement, 1 Språk
Item-grupper: Randomisation Number, 12 Lead ECG - Dosing Date and Time, 12-Lead ECG - Pre-dose-measurement 1 (of 3) at least 5 minutes apart, 12-Lead ECG - Pre-dose-measurement 2 (of 3) at least 5 minutes apart , 12-Lead ECG - Pre-dose-measurement 3 (of 3) at least 5 minutes apart , 12-Lead ECG - 30 mins, 12-Lead ECG - 1 hr, 12-Lead ECG - 24 hr , Vital Signs, Vital Signs - Pre dose, Vital Signs - 30 mins, Vital Signs - 24 hrs, Pharmacokinetics Blood - GW856553, Electronically Transferred Lab Data - Pre dose, Electronically Transferred Lab Data - 24 hrs (Day 2), Electronically Transferred Lab Data - 72 hrs (Day 4) , Investigational Product
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Period 2 - 12-Lead ECG; Vital Signs; Pharmacokinetics Blood GW856553; Electronically Transferred Lab Data; Investigational Product

- 23-04-19 - 1 Formulär, 8 Item-grupper, 50 Dataelement, 1 Språk
Item-grupper: Administrative Data, 12-Lead ECG, Vital Signs, Pharmacokinetics Blood - GW856553, Electronically Transferred Lab Data - Pre dose, Electronically Transferred Lab Data - 24 hrs (Day 2), Electronically Transferred Lab Data - 72 hrs (Day 4) , Investigational Product
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Period 3 - 12-Lead ECG; Vital Signs; Pharmacokinetics Blood GW856553; Electronically Transferred Lab Data; Investigational Product

- 23-04-19 - 1 Formulär, 8 Item-grupper, 50 Dataelement, 1 Språk
Item-grupper: Administrative Data, 12-Lead ECG, Vital Signs, Pharmacokinetics Blood - GW856553, Electronically Transferred Lab Data - Pre dose, Electronically Transferred Lab Data - 24 hrs (Day 2), Electronically Transferred Lab Data - 72 hrs (Day 4) , Investigational Product
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Period 4 - 12-Lead ECG; Vital Signs; Pharmacokinetics Blood GW856553; Electronically Transferred Lab Data; Investigational Product

- 23-04-19 - 1 Formulär, 8 Item-grupper, 50 Dataelement, 1 Språk
Item-grupper: Administrative Data, 12-Lead ECG, Vital Signs, Pharmacokinetics Blood - GW856553, Electronically Transferred Lab Data - Pre dose, Electronically Transferred Lab Data - 24 hrs (Day 2), Electronically Transferred Lab Data - 72 hrs (Day 4) , Investigational Product
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543 - Follow-up - Electronically Transferred Lab Data; 12-Lead ECG; Vital Signs; Study Conclusion; Pregnancy Information

- 23-04-19 - 1 Formulär, 9 Item-grupper, 40 Dataelement, 1 Språk
Item-grupper: Administrative Data, Electronically Transferred Lab Data - Pre dose, Electronically Transferred Lab Data - 24 hrs (Day 2), Electronically Transferred Lab Data - 72 hrs (Day 4) , 12-Lead ECG, Vital Signs, Study Conclusion, Pregnancy Information (F), Pregnancy Information (M)
Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

Estimation of Dose Proportionality of Darapladib - 107038 - PGx-Pharmacogenetic Research Withdrawal of Consent

- 13-11-18 - 1 Formulär, 1 Item-grupp, 4 Dataelement, 1 Språk
Item-grupp: PGx-Pharmacogenetic Research Withdrawal of Consent
Study ID: 107038 Clinical Study ID: LPL107038 Study Title: Study to Estimate the Dose Proportionality of the Enteric-Coated Freebase Formulation of SB-480848 Patient Level Data:  Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: Tyrisa ,US Study Indication: Atherosclerosis

Estimation of Dose Proportionality of Darapladib - 107038 - PGx-Pharmacogenetic Research Consent

- 13-11-18 - 1 Formulär, 1 Item-grupp, 6 Dataelement, 1 Språk
Item-grupp: PGx-Pharmacogenetic Research Consent Question
Study ID: 107038 Clinical Study ID: LPL107038 Study Title: Study to Estimate the Dose Proportionality of the Enteric-Coated Freebase Formulation of SB-480848 Patient Level Data:  Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: Tyrisa ,US Study Indication: Atherosclerosis

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