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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - Demography

- 10/6/20 - 1 formulario, 3 itemgroups, 15 items, 1 idioma

Itemgroups: Administrative Data, Demography, Race

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Demography Form has to be filled in at the Screening visit. Centre Number from Cover Sheets is included.

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - Physical Examination

- 10/6/20 - 1 formulario, 2 itemgroups, 31 items, 1 idioma

Itemgroups: Administrative Data, Physical Examination

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Physical Examination Form is used to record the physical examination at screening visit.

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - Medical Conditions

- 10/6/20 - 1 formulario, 2 itemgroups, 4 items, 1 idioma

Itemgroups: Administrative Data, Medical Conditions

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Medical Conditions Form is used to record current and past medical conditions at screening visit.

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - 12-Lead ECG Abnormalities

- 7/6/20 - 1 formulario, 8 itemgroups, 91 items, 1 idioma

Itemgroups: Administrative Data, 12-Lead ECG Abnormalities, Rhythm, P-Wave Morphology, Conduction, Myocardial Infarction, Depolarisation/Repolarisation (QRS-T), ECG, Other abnormalities

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The 12-Lead ECG Abnormalities Form has to be filled in whenever an abnormal ECG curve is recorded durig the study.

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - Eligibility Criteria

- 7/6/20 - 1 formulario, 4 itemgroups, 31 items, 1 idioma

Itemgroups: Administrative Data, Eligibility Question, Inclusion Criteria, Exclusion Criteria

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Eligibility Criteria Form has to be filled in at the screening visit. It determines the eligibility of the subject to participate in the study. Confirm that the subject is eligible to participate in the study and if not, that all the failed criteria have been marked.

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - Pregnancy Notification Form (Subject's Partner)

- 26/5/20 - 1 formulario, 6 itemgroups, 45 items, 1 idioma

Itemgroups: Administrative Data, Mother's relevant medical/family history, Father's Relevant Medical/Family History, Drug Exposures, Subject withdrawal, Reporting Investigator Information

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Pregnancy Notification Form is used to report pregnancy to GSK in specific cases specified by the Protocol. This form should be completed according to the protocol reporting requirements. Complete this form for each subject or subject’s partner who becomes pregnant during the study period. Send a copy of the form to GlaxoSmithKline (GSK will provide separately a list of contact names and information) by mail or fax (fax preferred) within two weeks of learning of the pregnancy. Original pages should remain with the subject’s Case Report Form. Note: This form does not routinely need to be completed for subject’s partner pregnancy unless there is specific instruction to do so stated in the protocol.

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - Serology - HIC, Hepatitis B & C Screen

- 26/5/20 - 1 formulario, 2 itemgroups, 6 items, 1 idioma

Itemgroups: Administrative Data, Serology - HIC, Hepatitis B & C Screen

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Serology - HIC, Hepatitis B & C Screen Form has to be filled in at the Screening Visit.

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - PGx - Pharmacogenetic Research

- 26/5/20 - 1 formulario, 5 itemgroups, 12 items, 1 idioma

Itemgroups: Administrative Data, consent Pharmacogenetic Test, BLOOD SAMPLE COLLECTION, WITHDRAWAL OF CONSENT, BLOOD SAMPLE DESTRUCTION

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Pharmacogenetic Research Form is used to record the state of informed consent for the pharmacogenetic research at the moments when the state changes. See the form sections for more details.

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - Study Conclusion, Pregnancy Information

- 26/5/20 - 1 formulario, 3 itemgroups, 7 items, 1 idioma

Itemgroups: Administrative Data, Study Conclusion, Pregnancy Information

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. This Form has to be filled in at the subject completion or withdrawal from the study.

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - Investigator Comment Log, Investigator's Signature

- 26/5/20 - 1 formulario, 3 itemgroups, 8 items, 1 idioma

Itemgroups: Administrative Data, Investigator Comment Log, Investigator's Signature

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. This Form confirms the accuracy of data by the Investigator and provides further comments. It has to be filled after the Screening and after Subject's participation in the study has ended.

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - Pharmacokinetics – blood; Metabolite profiling – plasma, Urine, Faeces

- 24/5/20 - 1 formulario, 5 itemgroups, 29 items, 1 idioma

Itemgroups: Administrative Data, Pharmacokinetics - Blood, Metabolite Profiling - Plasma, Metabolite Profiling - Urine, Metabolite Profiling - Faeces

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. This form is used to track sample collections during Treatment Period 1 & Treatment Period 2 starting prior with a sample collection prior to the drug administration. Urine and faeces collection can be ended at 168 if more than 90% of the radioactive dose administered was recovered from all matrices by then.

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - Serious Adverse Event (SAE)

- 24/5/20 - 1 formulario, 16 itemgroups, 67 items, 1 idioma

Itemgroups: Administrative Data, Serious Adverse Event, SECTION 1, SECTION 2: Seriousness, SECTION 3 Demography Data, SECTION 4 If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?, SECTION 5 Possible Causes of SAE Other Than Investigational Product(s), SECTION 6 RELEVANT Medical Conditions, SECTION 7 Other RELEVANT Risk Factors, SECTION 8 RELEVANT Concomitant Medications, SECTION 9 Details of Investigational Product(s) - Treatment Period 1, SECTION 9 Details of Investigational Product(s) - Treatment Period 2, SECTION 10 Details of relevant Assessments, SECTION 11 Narrative Remarks, Investigator's name and signature, SECTION 12: Additional/Follow-Up Information

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Serious adverse event (SAE) Form has to be filled in whenever such events occur during the study.

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