Ignite Creation Date:
2024-05-05 @ 11:48 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01425099
Status:
COMPLETED
Last Update Posted:
2011-11-06
First Post:
2011-08-18
Brief Title:
Drug Interaction Study Between Dolutegravir and Prednisone
Sponsor:
ViiV Healthcare
Organization:
ViiV Healthcare
Study Overview
Official Title:
An Adaptive Two Part Two Period Single Sequence Drug Interaction Study Between Dolutegravir 50 mg and Prednisone in Adult Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2011-10
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:
Dolutegravir DTG GSK1349572 is an integrase inhibitor that is currently in Phase 3 clinical development for the treatment of human immunodeficiency virus HIV infection DTG is primarily metabolized by UDP-glucuronosyltransferase UGT1A1 with cytochrome P450 CYP3A4 pathway as a minor route Corticosteroids have demonstrated induction effects on UGTs and CYP3A4 Corticosteroids are often used in HIV-infected subjects and have the potential to reduce DTG exposure due to enzyme induction when co-administered The primary objective of this study is to determine whether concomitant prednisone administration can affect the pharmacokinetics PK of DTG
The study is a two part two period open label study Part 1 will evaluate the effect of a high prednisone dose on DTG PK with the potential for an additional Part 2 depending on the results from Part 1 In Part 1 approximately 12 healthy subjects will receive DTG 50mg q24h for 5 days in Period 1 Subjects will then be administered DTG 50mg q24h in combination with prednisone 60mg for 5 days followed by a 5 day taper total duration of 10 days in Period 2 PK data of DTG will be obtained from Part 1 and used to inform decision making on the need for Part 2 If DTG exposure is reduced by more than 50 in Part 1 Part 2 will be carried out where a second cohort of subjects will receive DTG 50mg q24h DTG for 5 days in Period 1 followed by DTG 50mg q24h in combination with prednisone 20mg for 5 days followed by a 5 day taper total duration of 10 days in Period 2 Safety evaluations and serial PK samples for DTG will be collected during each treatment period A follow-up visit will occur 7-14 days after the last dose of study drug All doses of study drugs will be taken following a moderate fat meal This study will be conducted at one center in the United States with healthy adult male and female subjects
The study is a two part two period open label study Part 1 will evaluate the effect of a high prednisone dose on DTG PK with the potential for an additional Part 2 depending on the results from Part 1 In Part 1 approximately 12 healthy subjects will receive DTG 50mg q24h for 5 days in Period 1 Subjects will then be administered DTG 50mg q24h in combination with prednisone 60mg for 5 days followed by a 5 day taper total duration of 10 days in Period 2 PK data of DTG will be obtained from Part 1 and used to inform decision making on the need for Part 2 If DTG exposure is reduced by more than 50 in Part 1 Part 2 will be carried out where a second cohort of subjects will receive DTG 50mg q24h DTG for 5 days in Period 1 followed by DTG 50mg q24h in combination with prednisone 20mg for 5 days followed by a 5 day taper total duration of 10 days in Period 2 Safety evaluations and serial PK samples for DTG will be collected during each treatment period A follow-up visit will occur 7-14 days after the last dose of study drug All doses of study drugs will be taken following a moderate fat meal This study will be conducted at one center in the United States with healthy adult male and female subjects
Detailed Description:
None
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