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"}}},"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.
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Maraviroc and CYP3A5-derived metabolite PK will also be compared between African-Americans and Caucasians in subjects carrying two copies of the dysfunctional CYP3A5 alleles (*3, *6, and/or *7).","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"THE EFFECT OF CYP3A5 GENOTYPE ON THE PHARMACOKINETICS OF MARAVIROC","conditions":[{"DisplayValue":"Other","DisplayValue_OneLinkTx":"","InternalValue":"CON_OTHER","LookupValue":"Healthy Subjects","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 17:41:08","criteria":"Inclusion Criteria: - Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs) - Healthy female subjects and/or male subjects of African-American/Black or Caucasian race Exclusion Criteria: - History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males - Treatment with an investigational drug within 30 days - Screening supine blood pressure <90 or >/=140 mm Hg (systolic) or <60 or >/= 90 mm Hg (diastolic), following at least 5 minutes of supine rest - Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. - Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day - Subjects who have a CYP3A4*22 allele and/or have a SLCO1B1 *5 or *15 allele","detailed_description":"This will be an open-label, parallel group, multiple dose study in approximately 48 healthy male or female subjects of African American and Caucasian self-reported race, to assess the effect of CYP3A5 genotype on the PK of MVC and CYP3A5-derived metabolites. Maraviroc and CYP3A5-derived metabolite PK will also be compared between African-Americans and Caucasians in subjects carrying two copies of the dysfunctional CYP3A5 alleles (*3, *6, and/or *7). Dysfunctional genetic variants for CYP3A5, CYP3A4 and SLCO1B1 will be genotyped for subjects who participate in the pre-screening. Subjects who meet the inclusion/exclusion criteria for study participation will be placed into the study cohorts based on race and the number of functional (*1) and dysfunctional CYP3A5 alleles (*3, *6, and *7) CYP3A5 alleles. Cohort 1 (n=12; African-American): No CYP3A5*1 alleles (poor metabolizer). Cohort 2 (n=12; African-American): One CYP3A5*1 allele (intermediate metabolizer). Cohort 3 (n=12; African-American): Two CYP3A5*1 alleles (extensive metabolizer). Cohort 4 (n=12; Caucasian): No CYP3A5*1 alleles (poor metabolizer). Study Treatments: Part 1 Days 1-5: Maraviroc 300 mg BID in fasted state (AM dose only on Day 5). Part 2 (Cohorts 1 and 3 only) Days 1-10: Maraviroc 150 mg QD plus darunavir/cobicistat 800/150 mg QD with food. Pharmacokinetics of MVC, PF-6857639, PF-6857640 and other hydroxylated metabolites with formation mediated by CYP3A5 (if present) will be assessed on Part 1, Day 5 and Part 2, Days 10-11. Blood samples will be collected for a full PK profile. Subjects will be confined to the Clinical Research Unit (CRU) the day prior to dosing on Day 1 (Day 0) and discharged on Part 1, Day 6 and on Part 2, Day 11 (Cohorts 1 and 3 only). 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Treatment with an investigational drug within 30 days - Screening supine blood pressure <90 or >/=140 mm Hg (systolic) or <60 or >/= 90 mm Hg (diastolic), following at least 5 minutes of supine rest - Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. - Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day - Subjects who have a CYP3A4*22 allele and/or have a SLCO1B1 *5 or *15 allele","interventions":[{"arm_group_label":"Cohort 1","intervention_description":"300 mg twice daily x 5 days","intervention_name":"Maraviroc (Part 1)","intervention_type":"Drug"},{"arm_group_label":"Cohort 2","intervention_description":"300 mg twice daily x 5 days","intervention_name":"Maraviroc (Part 1)","intervention_type":"Drug"},{"arm_group_label":"Cohort 3","intervention_description":"300 mg twice daily x 5 days","intervention_name":"Maraviroc (Part 1)","intervention_type":"Drug"},{"arm_group_label":"Cohort 4","intervention_description":"300 mg twice daily x 5 days","intervention_name":"Maraviroc (Part 1)","intervention_type":"Drug"},{"arm_group_label":"Cohort 1","intervention_description":"150 mg once daily x 10 days","intervention_name":"Maraviroc (Part 2)","intervention_type":"Drug"},{"arm_group_label":"Cohort 3","intervention_description":"150 mg once daily x 10 days","intervention_name":"Maraviroc (Part 2)","intervention_type":"Drug"},{"arm_group_label":"Cohort 1","intervention_description":"800/150 mg once daily x 10 days","intervention_name":"Darunavir/cobicistat (Part 2)","intervention_type":"Drug"},{"arm_group_label":"Cohort 3","intervention_description":"800/150 mg once daily x 10 days","intervention_name":"Darunavir/cobicistat (Part 2)","intervention_type":"Drug"}],"interventional_subtype":"Treatment","is_fda_regulated":true,"is_high_value":false,"is_ind_study":true,"keywords":["Maraviroc, CYP3A5, pharmacokinetics, pharmacogenomics"],"last_follow_up_date":"03/26/2016 00:00:00","links":[{"description":"To obtain contact information for a study center near you, click here.","url":"https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4001110&StudyName=A%20Phase%201%2C%20Open-label%2C%20Parallel-group%20Study%20To%20Assess%20The%20Effect%20Of%20Cyp3a5%20Genotype%20On%20The%20Pharmacokinetics%20Of%20Maraviroc%20And%20Cyp3a5-derived%20Metabolites%20With%20And%20Without%20Darunavir%2Fcobicistat%20In%20African-american%20And%20Caucasian%20Healthy%20Volunteers"}],"locations":[{"City":"New Haven","Latitude":"41.3212912","CountryDisplay":"United States","Longitude":"-72.9283391","Name":"Pfizer New Haven Clinical Research Unit","StateDisplay":"CT","PostalCode":"06511","StatusDisplay":"No longer recruiting","StatusDisplayInternal":"LOCSTATUS_NO_LONG_REC","StatusMapped":"Recruitment Complete"}],"masking":"Open Label","maximum_age_raw":"55 Years","maximum_age":"55","minimum_age":"18","minimum_age_raw":"18 Years","modified_date":"10/01/2018 22:57:34","number_of_arms":"4","observational_design":{"biospecimen_description":"","biospecimen_retention":"","number_of_groups":"","observational_study_design":"","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":""},"official_title":"A Phase 1, Open-label, Parallel-group Study To Assess The Effect Of Cyp3a5 Genotype On The Pharmacokinetics Of Maraviroc And Cyp3a5-derived Metabolites With And Without Darunavir/cobicistat In African-american And Caucasian Healthy Volunteers","org_study_id":"A4001110","overall_contact":{"email":null,"last_name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021"},"overall_status":"Completed - 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