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Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Randomisation Number; Investigational Product; Treatment Confirmation

- 6/17/20 - 1 form, 4 itemgroups, 7 items, 1 language
Itemgroups: Administrative, Randomisation Number, Investigational Product, Treatment Confirmation
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Eligibility Question

- 9/17/21 - 1 form, 4 itemgroups, 26 items, 1 language
Itemgroups: Administrative, Eligibility Question, Inclusion Criteria, Exclusion Criteria
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Study Conclusion; Pregnancy Information; Investigator Comment Log, Investigator's Signature

- 6/23/20 - 1 form, 5 itemgroups, 13 items, 1 language
Itemgroups: Administrative, Study Conclusion, Pregnancy Information, Investigator Comment Log, Investigator's Signature
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Concomitant Medication

- 6/19/20 - 1 form, 3 itemgroups, 14 items, 1 language
Itemgroups: Administrative, Concomitant Medications, Concomitant Medications
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Pharmacogenetic Research

- 6/19/20 - 1 form, 4 itemgroups, 10 items, 1 language
Itemgroups: Consent for Pharmacogenetic Research, Blood Sample Collection, Withdrawal of Consent, Blood Sample Destruction
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Status of Treatment Blind

- 6/18/20 - 1 form, 2 itemgroups, 6 items, 1 language
Itemgroups: Administrative, Status of Treatment Blind
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Pharmacokinetics - Blood

- 6/18/20 - 1 form, 9 itemgroups, 33 items, 1 language
Itemgroups: Administrative, Pharmacokinetics - Blood (Session 1), Pharmacokinetics - Blood (Session 1), Pharmacokinetics - Blood (Session 2), Pharmacokinetics - Blood (Session 2), Pharmacokinetics - Blood (Session 3) , Pharmacokinetics - Blood (Session 3), Pharmacokinetics - Blood (Session 4), Pharmacokinetics - Blood (Session 4)
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Continuous Holter ECG

- 6/17/20 - 1 form, 4 itemgroups, 17 items, 1 language
Itemgroups: Administrative, Predose Continuous 24 hour Holter ECG (Day 1), Continuous 24 hour Holter ECG (Day 3), Continuous 48 hour Holter ECG (Day 5)
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Electronically Transferred Laboratory Data

- 6/17/20 - 1 form, 8 itemgroups, 15 items, 1 language
Itemgroups: Administrative, Electronically Transferred Laboratory Data - (Blood) Clinical Chemistry (Screening, Day -1, Day 1-5, Follow-up), Electronically Transferred Laboratory Data - (Blood) Haematology (Screening, Day -1, Day 1-5, Follow-up), Electronically Transferred Laboratory Data - (Urine) Urinalysis (Screening, Day -1, Day 1-5, Follow-up), Electronically Transferred Laboratory Data - (Blood) LFT's only (Day 4), Electronically Transferred Laboratory Data - (Blood) Clinical Chemistry (Unscheduled Assessments) , Electronically Transferred Laboratory Data - (Blood) Haematology (Unscheduled Assessments), Electronically Transferred Laboratory Data - (Urine) Urinalysis (Unscheduled Assessments)
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Urine Pregnancy Test; Serology

- 6/15/20 - 1 form, 3 itemgroups, 7 items, 1 language
Itemgroups: Administrative, Urine Pregnancy Test (Complete for Female Subjects Only) (Screening, Day-1, Follow-up), Serology
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - 12-Lead ECG

- 6/15/20 - 1 form, 4 itemgroups, 30 items, 1 language
Itemgroups: Administrative, 12-Lead ECG (Screening and Follow-up), 12-Lead ECG (Day 3 and 5), 12-Lead ECG (Unscheduled)
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Vital Signs

- 6/12/20 - 1 form, 5 itemgroups, 25 items, 1 language
Itemgroups: Administrative, Vital Signs (Screening), Vital Signs (Day 1-4), Vital Signs (Day 5), Vital Signs (Unscheduled Assessments)
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

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