Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT01467518
Status:
COMPLETED
Last Update Posted:
2012-04-09
First Post:
2011-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Methadone-Dolutegravir (DTG - GSK1349572) Drug Interaction Study.
Sponsor:
ViiV Healthcare
Organization:
Study Overview
Official Title:
A Phase 1, Open-Label, 2-Period Drug Interaction Study to Assess Steady State Plasma Methadone Enantiomer Pharmacokinetics Following Co-Administration of Methadone QD With Dolutegravir (GSK1349572) 50 mg Twice Daily in Opiate-Dependent, HIV Seronegative Adult Subjects.
Status:
COMPLETED
Status Verified Date:
2012-03
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:
Dolutegravir (DTG, GSK1349572) is an integrase inhibitor that is currently in Phase 3 clinical development for the treatment of HIV infection. As HIV-infected subjects may also be receiving methadone for opioid dependence, an evaluation of the potential interaction between DTG and methadone is warranted. The primary objective of this study is to determine whether concomitant administration of DTG can affect the pharmacokinetics (PK) of methadone. As a secondary endpoint, the PK of DTG will be compared to historical data. This study will be open-label with subjects receiving DTG and stable doses of methadone. The study will be conducted at one center in Canada in adult male and female subjects.
Detailed Description:
The study is an open label methadone- doltegravir (DTG, GSK1349572) drug interaction study consist of 2 periods. Subjects must be opiate-dependent and are HIV sero-negative and are on stable dose of methadone 14 days prior to pre-screening. After meeting all eligible criterions, subjects will remain on their individual methadone dose for 3 days in period 1. In period 2, subjects will continue on their individual stable dose of methadone and will receive 50 mg DTG every 12 hours for 5 days. Pharmacokinetics will be collected on Day 3 of period 1 and Day 5 of period 2. Safety measurements will be routine chemistry, haematology and urinalysis. Pharmacodynamic parameters for pupillometry and opioid symptom questionnaire will be collected at the same timepoints as for the pharmacokinetics. Subjects will be discharged after the last PK sample has been collected. A follow-up visit will occur 7-14 days after the last dose of study drug. This study will be conducted at one centre in Canada.
Study Oversight
Has Oversight DMC:
False
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?: