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GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Laboratory Collections 2, Dosing Details 2-3 - GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Laboratory Collections 2, Dosing Details

- 29.07.17 - 1 Formular, 3 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: clinical chemistry and hematology, pharmacokinetics, dosing details
Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Treatment Period 2 Laboratory Collections 2, Dosing Details 2-3

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dosing Details 1, Vital Signs 1, 12-Lead ECG Monitoring 1 - GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dosing Details, Vital Signs, 12-Lead ECG Monitoring

- 28.07.17 - 1 Formular, 3 Itemgruppen, 19 Datenelemente, 1 Sprache
Itemgruppen: dosing details, vital signs, 12-lead ecg monitoring
Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Treatment Period 2 Dosing Details 1, Vital Signs 1, 12-Lead ECG Monitoring 1

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Laboratory Collections 1

- 28.07.17 - 1 Formular, 5 Itemgruppen, 15 Datenelemente, 1 Sprache
Itemgruppen: urinanalysis, urine drug screening, alcohol breath test, urine cotinine test, serum b-HCG pregnancy test
Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Treatment Period 2 Laboratory Collections 1

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 1 Laboratory Collections 2

- 28.07.17 - 1 Formular, 3 Itemgruppen, 12 Datenelemente, 1 Sprache
Itemgruppen: clinical chemistry and hematology, pharmacokinetics, urine collection
Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Treatment Period 1 Laboratory Collections 2

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 1 Dosing Details, Vital Signs, 12-Lead ECG Monitoring - GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Dosing Details, Vital Signs, 12-Lead ECG Monitoring

- 28.07.17 - 1 Formular, 3 Itemgruppen, 22 Datenelemente, 1 Sprache
Itemgruppen: dosing details, vital signs, 12-lead ecg monitoring
Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Treatment Period 1 Dosing Details, Vital Signs, 12-Lead ECG Monitoring

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 1 Laboratory Collections 1 - GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 1 Laboratory Collections

- 26.07.17 - 1 Formular, 5 Itemgruppen, 15 Datenelemente, 1 Sprache
Itemgruppen: urinanalysis, urine drug screening, alcohol breath test, urine cotinine test, serum b-HCG pregnancy test
Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Treatment Period 1 Laboratory Collections 1

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Serious Adverse Event (SAE), Investigator's Statement

- 26.07.17 - 1 Formular, 2 Itemgruppen, 32 Datenelemente, 1 Sprache
Itemgruppen: Serious Adverse Event, investigators checklist
Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Serious Adverse Event, Investigator's Statement

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Laboratory Collections

- 23.07.17 - 1 Formular, 7 Itemgruppen, 20 Datenelemente, 1 Sprache
Itemgruppen: clinical chemistry and hematology, urinanalysis, urine drug screening, hiv, hepatitis b, hepatitis c, alcohol breath test, urine cotinine test, Serum b-HCG Pregnancy Test
Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Laboratory Collections

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Demography, Medical History and Physical Examination

- 22.07.17 - 1 Formular, 5 Itemgruppen, 32 Datenelemente, 1 Sprache
Itemgruppen: Demography, medical history, physical examination, vital signs, 12-lead ecg
Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation parts: Demography, Medical History and Physical Examination

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Eligibility Checklist

- 17.07.17 - 1 Formular, 2 Itemgruppen, 29 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Eligibility Checklist

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