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dbGaP phs000931 DMET Genes, Nicotine Metabolism and Prospective Abstinence - pht009405.v1.p1

- 27/11/2024 - 7 Formulários, 1 Grupo de itens, 7 Elementos de dados, 1 Idioma
Grupo de itens: pht009405
Principal Investigator: Andrew W. Bergen, PhD, SRI International, Menlo Park, CA, USA; Oregon Research Institute, Eugene, OR, USA MeSH: Nicotine,Pharmacokinetics,Smoking Cessation,Cigarette Smoking,Smoking Cessation Agents,Bupropion,Tobacco Use Cessation Devices,Lung Neoplasms https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000931 This study (DA033813; PI: Andrew W Bergen; PMID:26132489) includes samples from two laboratory studies of nicotine metabolism. The Pharmacokinetics of Nicotine Metabolism in Twins study (PKTWIN; PI: Gary E Swan; PMID: 15527659) was based on recruitment from a twin registry (PMID: 23084148). The Integrated Research Project on Tobacco Use and Dependence (IRP; PI: Gary E Swan; PMID: 14578134) was based on recruitment from a pedigree-based longitudinal study of risk factors for substance use, the Smoking in Families study (SMOFAM; DA03706; PI: Hy Hops). These two laboratory studies (PKTWIN and IRP/SMOFAM) served as the Stage I dataset to interrogate Drug Metabolizing Enzyme and Transporter genes with a targeted SNP array for association with the Nicotine Metabolite Ratio (NMR, ratio of trans-3'-hydroxycotinine and cotinine), an established biomarker of nicotine metabolism. In addition to the laboratory studies, samples from eight RCTs (PMID: 23249876) with the NMR and smoking-related measures used to test SNPs identified in Stage I (PMID: 26132489). In a third stage, a lung cancer meta-analysis database (PMID: 24880342) was used to assess association of SNPs identified in Stage II with lung cancer. The objectives of the study were to identify novel genes and SNPs contributing to nicotine metabolism (Stage I), and to validate PK SNPs associated with the NMR from individuals participating in a clinical laboratory protocol with the NMR obtained from treatment-seeking smokers, and then to investigate association with prospective smoking cessation (Stage II). This study built upon existing studies of nicotine metabolism and randomized trials of smoking cessation therapies. Enhanced knowledge of the genes influencing nicotine metabolism and prospective abstinence may help personalize smoking cessation treatment and risk assessment for smoking-related diseases. For Stage I, both subject [fixed-dose NMR, covariates (age, BMI, ethnicity, sex, smoking status, and hormone use), and pedigree relationships] and sample (common DMET SNP genotype, genotyping quality control) data are available in this accession. The analysis protocol, quality control summaries, summary genotype, summary phenotype, and analysis results are available for Stage I, II and III samples (PMID: 26132489). Extensive discussion of the prior *CYP2A6* association literature with the NMR, abstinence, smoking heaviness and lung cancer risk is available (PMID: 26132489). The NMR has previously been associated with *CYP2A6* activity, response to smoking cessation treatments, and cigarette consumption. We searched for drug metabolizing enzyme and transporter (DMET) gene variation associated with the NMR and prospective abstinence in 2,946 participants of laboratory studies of nicotine metabolism and of clinical trials of smoking cessation therapies. Stage I was a meta-analysis of the association of 507 common single nucleotide polymorphisms (SNPs) at 173 DMET genes with the NMR in 449 participants of two laboratory studies. Nominally significant associations were identified in ten genes after adjustment for intragenic SNPs; *CYP2A6* and two *CYP2A6* SNPs attained experiment-wide significance adjusted for correlated SNPs (*CYP2A6* PsubACT/sub=4.1E-7, rs4803381 PsubACT/sub=4.5E-5, rs1137115, PsubACT/sub=1.2E-3). Stage II was mega-regression analyses of 10 DMET SNPs with pretreatment NMR and prospective abstinence in up to 2,497 participants from eight trials. rs4803381 and rs1137115 SNPs were associated with pretreatment NMR at genome-wide significance. In *post-hoc* analyses of *CYP2A6* SNPs, we observed nominally significant association with: abstinence in one pharmacotherapy arm; cigarette consumption among all trial participants; and lung cancer in four case:control studies. *CYP2A6* minor alleles were associated with reduced NMR, CPD, and lung cancer risk. We confirmed the major role that *CYP2A6* plays in nicotine metabolism, and made novel findings with respect to genome-wide significance and associations with CPD, abstinence and lung cancer risk. Additional multivariate analyses with patient variables and genetic modeling will improve prediction of nicotine metabolism, disease risk and smoking cessation treatment prognosis.br

pht009401.v1.p1

1 Grupo de itens 7 Elementos de dados

Eligibility

1 Grupo de itens 7 Elementos de dados

pht009400.v1.p1

1 Grupo de itens 2 Elementos de dados

pht009402.v1.p1

1 Grupo de itens 2 Elementos de dados

pht009403.v1.p1

1 Grupo de itens 17 Elementos de dados

pht009404.v1.p1

1 Grupo de itens 11 Elementos de dados

The relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time NCT00945503 - Day 1 - Vital Signs; 12-Lead ECG; Laboratory Results Data (Haematology, Clinical Chemistry) - Pre-Dose and 24h Post-Dose; Urinalysis - Pre-Dose and 24h Post-Dose; Randomisation Number; Investigational Product; Treatment Confirmation; PET Scan (2); fMRI Scan - Post-PET Scan; PET Scan (3); Pharmacokinetics - Blood

- 06/04/2022 - 1 Formulário, 16 Grupos de itens, 158 Elementos de dados, 1 Idioma
Grupos de itens: Administrative, Vital Signs, 12-Lead ECG, Laboratory Results Data (Haematology) - Pre-Dose, Laboratory Results Data (Clinical Chemistry) - Pre-Dose, Urinalysis - Pre-Dose, Randomisation Number, Investigational Product, Treatment Confirmation, PET Scan (2), fMRI Scan - Post-PET Scan, PET Scan (3), Pharmacokinetics - Blood, Laboratory Results Data (Haematology) - 24hrs Post-Dose, Laboratory Result Data (Clinical Chemistry) - 24hrs Post-Dose, Urinalysis - 24hrs Post-Dose
Study ID: 109731 Clinical Study ID: 109731 Study Title: An adaptive PET study in healthy volunteers using 11C GSK931145 to establish the relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00945503 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1018921 Study Indication: Schizophrenia

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - PK Blood Sample

- 26/11/2021 - 1 Formulário, 3 Grupos de itens, 9 Elementos de dados, 1 Idioma
Grupos de itens: Administrative Data, Dosing date and time, PK Blood Sample
Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. Depending on which items, this form has to be filled out at the Cycle 1 week 1, 2, 3 and 4 visits, Cycle 2 week 1, 2, 3 and 4 visits, Cycle 1 and 2 observation visits and unscheduled visits.

Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384 - Repeat Local laboratory, urinalysis, vital signs, ECG and Pharmacokinetics

- 20/09/2021 - 1 Formulário, 8 Grupos de itens, 58 Elementos de dados, 1 Idioma
Grupos de itens: Local Laboratory, Urinalysis | Local, Vital signs, 12 lead ECG, Electrocardiogram abnormal, Drug Kinetics; Blood, 12 lead ECG | Holter Electrocardiography | Summary Report, Holter Electrocardiography | Electrocardiogram abnormal | Summary Report
Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram

NCT00486954_Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer - PK Dosing Date Time

- 20/09/2021 - 1 Formulário, 1 Grupo de itens, 1 Elemento de dados, 1 Idioma
Grupo de itens: PK Dosing
https://clinicaltrials.gov/ct2/show/NCT00486954 Study ID: 104578 Clinical Study ID: EGF104578 Study Title: A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination with weekly Paclitaxel versus weekly Paclitaxel alone in the second line treatment of ErbB2 amplified Advanced Gastric Cancer Patient Level Data: Clinicaltrials.gov Identifier: NCT00486954 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Product Sponsorship Transferred to Novartis Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Gastrointestinal Tract CRF Seiten: 1288-1609

Safety, tolerance and preliminary pharmacokinetics of single ascending intravenous doses of halofantrine [SK&F 102886] in healthy male volunteers. - Administration, demographics, inclusion criteria, exclusion criteria, infusion details, ecg, alcohol/drug screening, baseline/advers events

- 20/09/2021 - 1 Formulário, 14 Grupos de itens, 86 Elementos de dados, 1 Idioma
Grupos de itens: Administration, Demographic Details, Volunteer Inclusion Criteria, Volunteer Exclusion Criteria, Infusion Details, ECG-Arrhythmia, Electrocardiography, Electrocardiography, Alcohol Screening (Blow test), Drug Screening (Urine), Baseline Events, Baseline Events, Adverse Events, Adverse Events
https://www.gsk-clinicalstudyregister.com/study/102886/003?search=study&study_ids=102886#csr Study ID : 102886/003 Clinical Study ID : 102886/003 Study Title :Safety, tolerance and preliminary pharmacokinetics of single ascending intravenous doses of halofantrine [SK&F 102886] in healthy male volunteers. Clinicaltrials.gov Identifier : Sponsor : GlaxoSmithKline Collaborators :N/A Phase :N/A Study Recruitment Status :Completed Generic Name :halofantrine Trade Name :Halfan Study Indication Malaria

Safety, tolerance and preliminary pharmacokinetics of single ascending intravenous doses of halofantrine [SK&F 102886] in healthy male volunteers. - Glucose assay, plasma drug assay, volunteer completion/withdrawal, investigator's statement, concominant medication, missing data form

- 20/09/2021 - 1 Formulário, 13 Grupos de itens, 56 Elementos de dados, 1 Idioma
Grupos de itens: Administration, Glucose Assay, Glucose Assay, Plasma Drug Assay, Plasma Drug Assay, Volunteer Completion/Withdrawal, Investigator's checklist, Investigator's Statement, Concominant Medication, Missing Data, Missing Data, Missing Data, Missing Data
https://www.gsk-clinicalstudyregister.com/study/102886/003?search=study&study_ids=102886#csr Study ID : 102886/003 Clinical Study ID : 102886/003 Study Title :Safety, tolerance and preliminary pharmacokinetics of single ascending intravenous doses of halofantrine [SK&F 102886] in healthy male volunteers. Clinicaltrials.gov Identifier : Sponsor : GlaxoSmithKline Collaborators :N/A Phase :N/A Study Recruitment Status :Completed Generic Name :halofantrine Trade Name :Halfan Study Indication Malaria

Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989 - Eligibility Criteria

- 20/09/2021 - 1 Formulário, 4 Grupos de itens, 33 Elementos de dados, 1 Idioma
Grupos de itens: Administrative Data, Eligibility question, Inclusion Criteria, Exclusion Criteria
Study ID: 111539 Clinical Study ID: 111539 Study Title: A Single-Blind Study of the Safety, Pharmacokinetics and Pharmacodynamics of scalating Repeat Doses of GSK249320 in Patients With Stroke Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00833989 https://clinicaltrials.gov/ct2/show/NCT00833989 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Refanezumab, Placebo Trade Name: N/A Study Indication: Ischaemic Attack, Transient The study consists of 8 visits: Day 1, Week 1 (Day 5), Week 2 (Day 10), Week 4 (Day 30), Week 8 (Day 60), Week 12 (Day 90), Week 16 (Day 112), Follow-up (F/U). All subjects will receive two doses. The first dose within 24-72 hrs after stroke the second dose 9 +/- 1 days after the first one. Each dose will be given as an intravenous infusion over 60 minutes. This document contains the eligibility criteria. It has to be filled in at Day 1.

PART B - Period 1 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 20/09/2021 - 1 Formulário, 18 Grupos de itens, 90 Elementos de dados, 1 Idioma
Grupos de itens: Note, Inclusion Criteria, Exclusion Criteria, Physical examination, Pregnancy test, Alcohol test, Urine drug screening, orthostatic blood pressure / Pulse - Predose, Concomitant medication, Adverse event, Patient diary, Randomization, High fat breakfast, Study Drug Dosing, Orthostatic blood pressure / pulse measurement - post dose, Adverse Event - post dosing, Pharmacokinetic sampling post dosing, Discharge
PART B - Period 1 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Day 1 - Summary Holter; Summary Holter Abnormalities; Electronically Transferred Lab Data; Pharmacokinetics Blood; Urinalysis

- 20/09/2021 - 1 Formulário, 24 Grupos de itens, 323 Elementos de dados, 1 Idioma
Grupos de itens: Date of Visit, Summary Holter, Summary Holter Abnormalities, Electroniclly Transferred Lab Data - Dosing Date and Time, Electronically Transerred Lab Data - Pre-dose, Electronically Transerred Lab Data - 1 Hour, Electronically Transerred Lab Data - 2 Hour , Electronically Transerred Lab Data - 4 Hour, Electronically Transerred Lab Data - 8 Hour , Electronically Transerred Lab Data - 24 Hour, Electronically Transerred Lab Data - 36 Hour , Electronically Transerred Lab Data - 48 Hour, Electronically Transerred Lab Data - 72 Hour , Pharmacokinetics Blood, Pharmacokinetics Blood - Extra Scheduled Samples Entry , Urinalysis - Dosing Date and Time , Urinalysis Dipstick Details - Pre-Dose, Urinalysis Dipstick Details - 2 Hour Post-Dose, Urinalysis Dipstick Details - 4 Hour Post-Dose , Urinalysis Dipstick Details - 8 Hour Post-Dose , Urinalysis Dipstick Details - 24 Hour Post-Dose , Urinalysis Dipstick Details -36 Hour Post-Dose, Urinalysis Dipstick Details -48 Hour Post-Dose , Urinalysis - Local: Microscopy Details
Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

Pharmacokinetics

- 20/09/2021 - 1 Formulário, 1 Grupo de itens, 23 Elementos de dados, 1 Idioma
Grupo de itens: Pharmacokinetics
Record detailed information about the collection of biological samples for analysis of the presence and quantity of the study agent and/or its metabolites. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AD257392-F827-EFBD-E040-BB89AD434E1E

Eligibility Acute Heart Failure DRKS00008447 NCT02151383 - Eligibility Acute Heart Failure NCT02151383

- 17/09/2021 - 1 Formulário, 2 Grupos de itens, 18 Elementos de dados, 1 Idioma
Grupos de itens: Inclusion Criteria, Exclusion Criteria
Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT02151383

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