Ignite Creation Date:
2024-05-06 @ 7:53 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02625207
Status:
COMPLETED
Last Update Posted:
2017-04-17
First Post:
2015-10-20
Brief Title:
THE EFFECT OF CYP3A5 GENOTYPE ON THE PHARMACOKINETICS OF MARAVIROC
Sponsor:
ViiV Healthcare
Organization:
ViiV Healthcare
Study Overview
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 DarunavirCobicistat In African-american And Caucasian Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor 7
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 andor 7
Dysfunctional genetic variants for CYP3A5 CYP3A4 and SLCO1B1 will be genotyped for subjects who participate in the pre-screening Subjects who meet the inclusionexclusion 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 n12 African-American No CYP3A51 alleles poor metabolizer Cohort 2 n12 African-American One CYP3A51 allele intermediate metabolizer
Cohort 3 n12 African-American Two CYP3A51 alleles extensive metabolizer
Cohort 4 n12 Caucasian No CYP3A51 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 darunavircobicistat 800150 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 Subjects enrolled into Cohorts 1 and 3 may be confined to the CRU without the need to be discharged between Part 1 and Part 2
Dysfunctional genetic variants for CYP3A5 CYP3A4 and SLCO1B1 will be genotyped for subjects who participate in the pre-screening Subjects who meet the inclusionexclusion 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 n12 African-American No CYP3A51 alleles poor metabolizer Cohort 2 n12 African-American One CYP3A51 allele intermediate metabolizer
Cohort 3 n12 African-American Two CYP3A51 alleles extensive metabolizer
Cohort 4 n12 Caucasian No CYP3A51 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 darunavircobicistat 800150 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 Subjects enrolled into Cohorts 1 and 3 may be confined to the CRU without the need to be discharged between Part 1 and Part 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None