Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00942136 | GSK1349572 Proton Pump Inhibitor Drug Interaction and Supratherapeutic Dose Study | PHASE1 | COMPLETED | 24 | — | — | Jul 1, 2009 | Sep 1, 2009 | Oct 9, 2009 | 1 | United States |
| NCT00883935 | GSK1349572 Drug Interaction Study With Atazanavir/Ritonavir and Atazanavir | PHASE1 | COMPLETED | 24 | — | — | Apr 1, 2009 | Jun 1, 2009 | Jun 22, 2009 | 1 | United States |
| NCT00858455 | A Study to Evaluate the Effect of Antacid and Multivitamin and Mineral Tablet on the Study Drug GSK1349572 | PHASE1 | COMPLETED | 16 | — | — | Jan 1, 2009 | Mar 1, 2009 | Jun 5, 2009 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Cohort 1, Sequence 1 | EXPERIMENTAL | 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. |
| Cohort 2 | EXPERIMENTAL | 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. |
| Cohort 1, Sequence 2 | EXPERIMENTAL | 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. |
| Sequence 2 | EXPERIMENTAL | In the first treatment period, all subjects will receive GSK1349572 30mg q24h for 5 days (treatment A). In period two, subjects will receive GSK1349572 30mg q24h in combination with ATV 400mg q24h (treatment C) for 14 days. There will be no washout between treatment periods. Day 1 of Period 2 will be the day after Day 5 of Period 1. Subjects will have a screening visit within 30 days prior to the first dose of study drug, two treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. |
| Sequence 1 | EXPERIMENTAL | In the first treatment period, all subjects will receive GSK1349572 30mg q24h for 5 days (treatment A). In period two, subjects will receive GSK1349572 30mg q24h in combination with ATV/RTV 300/100mg q24h (treatment B) for 14 days. There will be no washout between treatment periods. Day 1 of Period 2 will be the day after Day 5 of Period 1. Subjects will have a screening visit within 30 days prior to the first dose of study drug, two treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. |
| Healthy Volunteers | EXPERIMENTAL | 4 period cross over |
| Name | Type | Description |
|---|---|---|
| GSK1349572 | DRUG | 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. |
| Placebo | DRUG | Placebo Suspension as a single dose. |
| Omeprazole | DRUG | 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. |
| Atazanavir 300 mg | DRUG | Atazanavir 300 mg once per day for 14 days in Period 2 |
| Atazanavir 400 mg | DRUG | Atazanavir 400 mg once a day for 14 days in Period 2 |
| Ritonavir | DRUG | Ritonavir 100 mg once a day for 14 days in Period 2 |
| GSK1349572 and MaaloxAdvanced Maximum Strength | DRUG | A single dose of GSK1349572 co-administered with a single dose of 20 mL of Maalox Advanced Maximum Strength |
| GSK1349572 and Maalox Advanced Maximum Strength | DRUG | A single dose of GSK1349572 administered 2 hours prior to administration of a single dose of 20 mL of Maalox Advanced Maximum Strength |
| GSK1349572 and One A Day | DRUG | A single dose of GSK1349572 50 mg co-administered with a single dose of a One A Day Maximum multivitamin |
Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. * Male or female between 18 and 65 years of age, inclusive. * A female subject is eligible ...