Clinical trial NCT00942136: GSK1349572 Proton Pump Inhibitor Drug Interaction and Supratherapeutic Dose Study
Official title: The Official Study Title Exceeds the 300 Character Limit for This Field. See Detailed Study Description Section for Official Study Title.
Conditions: Healthy Volunteer
Summary: GSK1349572 is an integrase inhibitor that is currently being evaluated for the treatment of HIV infection. The primary objective of this study is to determine whether the addition of a proton pump inhibitor, omeprazole, to GSK1349572 impacts the blood levels of GSK1349572. It will also evaluate if a high fat meal impacts the blood levels of GSK1349572. In addition, the safety, tolerability, and pharmacokinetics of single supratherapeutic (high) dose of GSK1349572 will be evaluated.
Interventions:
description: GSK1349572 250 mg suspension as a single dose. GSK1349572 is an investigational (not approved by the FDA) medication for the treatment of HIV in the class of integrase inhibitors.
name: GSK1349572
type: Drug
description: GSK1349572 50 mg tablets as a single dose on three separate occasions. GSK1349572 is an investigational (not approved by the FDA) medication for the treatment of HIV in the class of integrase inhibitors.
name: GSK1349572
type: Drug
description: Placebo Suspension as a single dose.
name: Placebo
type: Drug
description: Omeprazole 40 mg once a day for 5 days. Omeprazole is approved by the FDA currently to reduce stomach acid, treat stomach ulcers, and gastroesophageal reflux disease.
name: Omeprazole
other_name: PRILOSEC. PRILOSEC is a registered trademark of AstraZeneca, LP.
type: Drug
Study arms:
design_group_description: Subjects in Cohort 1, Sequence 1 will receive a single dose of GSK134972 50 mg after a fast of 10 hours in Period 1. Following a 7 day washout, they will receive a single dose of GSK134972 50 mg after a high fat meal in Period 2. After the last PK sample is collected in Period 2, they will receive a single daily dose of omeprazole 40 mg for 5 days. On Day 5 they will receive a single dose of GSK134972 50 mg 2 hours after the omeprazole dose. Subjects will have a screening visit 30 days prior to the first dose and a follow-up visit 7-14 days after the last dose of medication.
design_group_title: Cohort 1, Sequence 1
design_group_type: Experimental
design_group_description: Subjects will receive a single dose of either GSK1349572 250 mg or placebo as a suspension. Subjects will have a screening visit within 30 days prior to the dose of study medication and a follow up visit 7-14 days after the dose of study medication.
design_group_title: Cohort 2
design_group_type: Experimental
design_group_description: Subjects in Cohort 1, Sequence 2 will receive a single dose of GSK134972 50 mg after a a high fat meal in Period 1. Following a 7 day washout, they will receive a single dose of GSK134972 50 mg after fast of 10 hours in Period 2. After the last PK sample is collected in Period 2, they will receive a single daily dose of omeprazole 40 mg for 5 days. On Day 5 they will receive a single dose of GSK134972 50 mg 2 hours after the omeprazole dose. Subjects will have a screening visit 30 days prior to the first dose and a follow-up visit 7-14 days after the last dose of medication.
design_group_title: Cohort 1, Sequence 2
design_group_type: Experimental
Sponsor: GSK Plc
Collaborators: Shionogi, Inc.
Drug name mappings:
name: 多替拉韦钠
lang: CN
name: Dolutegravir Sodium
lang: EN
name: ドルテグラビルナトリウム
lang: JP
name: 奥美拉唑
lang: CN
name: Omeprazole
lang: EN
name: オメプラゾール
lang: JP