If you entered a web address please check it was correct.
\nYou can also try Search Page to find the study you are looking for.
"}}},"trialDetailsJson":{"title":"Details Page","returnSearch":"Back to search results","description":"Study Description","identifier":"ViiV Study ID","clinicalID":"Clinicaltrials.gov Identifier","EudraCtID":"EudraCT Number","resultsAvailable":"Has Results Available Below","docAvailable":"Has Results Document Available","studyOverview":"Study Overview","overviewSection":{"conditionsDisplay":"Medical Conditions","product":"Product","collaborators":"Collaborators","dates":"Date","studyType":"Type","phase":"Phase","gender":"Gender","age":"Age","acceptVolunteers":"Accepts Healthy Volunteers"},"studyDocuments":"Study Documents","noDocuments":"No documents available","studyDocumentsAdditionalText":"If you wish to request for Full Study Report, please contact - ","studyDocumentsAdditionalEmail":"GSKClinicalSupportHD@gsk.com","isReleased":{"firstPart":"This study has Protocol and Result summary on ClinicalTrial.gov. Click","secondPart":"to learn more.","linkText":"here"},"mapLocations":"Locations","centralContact":"Central Contact","centralPhone":"Central Contact Phone","centralEmail":"Central Contact Email","mapSection":{"site":"GSK Investigational Site","condition":"Condition","id":"Study ID","city":"City","state":"State","zip":"Zip","country":"Country"},"studyDesign":"Study Design","designSection":{"purpose":"Primary Purpose","allocation":"Allocation","study_design":"Study Design","study_classification":"Study Classification","masking":"Masking","masked_subject":"Masked Subject","masked_caregiver":"Masked Caregiver","masked_investigator":"Masked Investigator","masked_assessor":"Masked Assessor","primary_outcomes":"Primary Outcomes","secondary_outcomes":"Secondary Outcomes","arms":"Arms","interventions":"Interventions","keyword":"Keyword","inclusionTitle":"Inclusion Criteria","exclusionTitle":"Exclusion Criteria","criteriaText":"Inclusion/Exclusion Criteria","criteria_button":"Click to view inclusion/exclusion criteria","enrollment":"Enrollment","clinicalPublications":"Clinical Publications"},"popoversText":{"studyId":{"childMarkdownRemark":{"html":"A unique number for a study given by ViiV.
"}},"ctGov":{"childMarkdownRemark":{"html":"This number identifies the study on the US clinicaltrials.gov register. Click this link to go to the entry for this study on Clinicaltrials.gov where you will be able to see protocol and results summaries where available.
"}},"eudraCT":{"childMarkdownRemark":{"html":"This number identifies the study on the EU clinicaltrials.eu register. Click this link to go to the entry for this study on clinicaltrials.eu where you will be able to see protocol and results summaries where available.
"}}}},"site":{"siteMetadata":{"siteUrl":"https://www.viiv-studyregister.com"}},"studyDetails":{"nct_number":"NCT02206711","ctis_id":"","HasResults":"false","IpdAccessCriteria":"","IpdDescription":"","IpdInfoTypeAnalyticCode":"","IpdInfoTypeIcf":"","IpdInfoTypeCsr":"","IpdInfoTypeProtocol":"","IpdInfoTypeSap":"","IpdTimeFrame":"","IpdUrl":"","IsFlexibleTrial":false,"IsReleasedToCtGov":"true","MaskingInfo":{"masked_assessor":"false","masked_caregiver":"false","masked_investigator":"false","masked_subject":"false","masking_description":"","no_masking":"true"},"PatientLevelData":"false","SharingIpd":"","acronym":"","allocation":"Non-randomized","arm_groups":[{"arm_group_label":"Single oral dose of [14C] BMS 955176","arm_group_description":"A single 180 mg oral dose of [14C] BMS-955176 containing approximately 80 microcurie of total radioactivity.","arm_type":"Experimental"},{"arm_group_label":"Nasoduodenal (ND) Tube Cohort","arm_group_description":"A single dose of [14C] BMS 955176 on Day 1 with ND placement 1 hour post dose to facilitate continuous bile collection though 8 hours post dose.","arm_type":"Experimental"}],"assignment":"Single Group Assignment","brief_summary":"The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and extent of elimination, safety and tolerability of a single oral dose of [14C] BMS-955176 in healthy male subjects. There is no formal research hypothesis to be statistically tested for this study.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Study of the absorption, metabolism, and route of elimination of a novel class of anti-HIV 1 drugs (BMS-955176) in humans.","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"HIV infections","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 17:25:34","criteria":"Inclusion Criteria: - Healthy Male subjects - Ages 18-50 years - Body weight of at least 110 lbs (50kg) - BMI of 18 to 32 kg/m^2 - non-smoking Exclusion Criteria: - Clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months (eg serial X-ray or CAT scans, barium meals). - gastrointestinal disease including gastrointestinal surgery - constipation or irregular bowel movements","detailed_description":"","display_gender":"Male","display_gender_internal":"GENDER_MALE","display_phase":"Phase 1","display_phase_internal":"PHASE_1","display_status":"Completed","display_status_internal":"RECSTATUS_I_COMPLETED","endpoint":"","enrollment":"21","exclusion":"","gender":"Male","gender_based":"","gender_description":"","healthy_volunteers":"Yes","id":"f1fdf74c-d489-5a13-bf4c-cf624dada67d","internal":{"content":null,"contentDigest":"65aac52108e0b188d6e2e68a4a90239f","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - Healthy Male subjects - Ages 18-50 years - Body weight of at least 110 lbs (50kg) - BMI of 18 to 32 kg/m^2 - non-smoking Exclusion Criteria: - Clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months (eg serial X-ray or CAT scans, barium meals). - gastrointestinal disease including gastrointestinal surgery - constipation or irregular bowel movements","interventions":[{"arm_group_label":"Single oral dose of [14C] BMS 955176","intervention_description":"Single dose of drug on Day 1","intervention_name":"BMS-955176","intervention_type":"Drug"},{"arm_group_label":"Nasoduodenal (ND) Tube Cohort","intervention_description":"Single dose of drug on Day 1","intervention_name":"BMS-955176","intervention_type":"Drug"}],"interventional_subtype":"Other","is_fda_regulated":true,"is_high_value":false,"is_ind_study":true,"keywords":[],"last_follow_up_date":"09/09/2014 00:00:00","links":[],"locations":[{"City":"Madison","Latitude":"43.1438143","CountryDisplay":"United States","Longitude":"-89.3511495","Name":"GSK Investigational Site","StateDisplay":"Wisconsin","PostalCode":"53704","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"}],"masking":"Open Label","maximum_age_raw":"50 Years","maximum_age":"50","minimum_age":"18","minimum_age_raw":"18 Years","modified_date":"10/01/2018 22:45:18","number_of_arms":"2","observational_design":{"biospecimen_description":"","biospecimen_retention":"","number_of_groups":"","observational_study_design":"","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":""},"official_title":"Pharmacokinetics and Metabolism of [14C] BMS-955176 in Healthy Male Subjects","org_study_id":"206291","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Completed - Interventional","oversight_info":{"exported_from_us":"","fda_regulated_device":"","fda_regulated_drug":"","ped_postmarket_surv":"","has_dmc":false,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"Phase 1","primary_compl_date":"09/09/2014 00:00:00","primary_outcomes":[{"outcome_description":"Serial blood samples for PK parameters determined from plasma concentration versus time","outcome_measure":"To asses the PK (AUC, Cmax) of a single oral dose","outcome_time_frame":"Day 1 through Day 13 (predose to 288 hours)","outcome_safety_issue":null},{"outcome_description":"Sample of urinary/fecal/bile will be collected for determining total recovery.","outcome_measure":"To estimate extent of elimination of a single oral dose (% TRA recovery)","outcome_time_frame":"Day 1 through Day 13 (predose to 288 hours)","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[{"id":"AI468-036","id_type":"Other Identifier","id_domain":"Bristol-Myers Squibb"}],"secondary_outcomes":[{"outcome_description":"Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.","outcome_measure":"Safety Assessment","outcome_time_frame":"Day 1 through Day 13","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"None","lead_sponsor":"ViiV Healthcare","collaborators":["GlaxoSmithKline"]},"start_date":"08/08/2014 00:00:00","study_type":"Interventional","therapeutic_area":"Infectious Diseases","citations":[],"is_section_801":false}},"pageContext":{"studyId":"206291"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}