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GSK1349572 and MaaloxAdvanced Maximum Strength · 3 trials · 1 indication
| 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 ...
GSK1349572 is an investigational small molecule being developed for the treatment of Human Immunodeficiency Virus (HIV) infection, including HIV-1. It has been studied in healthy volunteers and in patients with HIV, including those with tuberculosis or herpesviridae co-infections.
GSK1349572 is being developed by GSK plc, which trades under the ticker GSK. The company has conducted clinical trials of this drug in the United States and multiple other countries.
GSK1349572 has been studied in Phase 1 and Phase 3 clinical trials. The Phase 3 trial compared GSK1349572 50mg once daily to raltegravir 400mg twice daily in patients with HIV-1 infection.
GSK1349572 has been studied in several completed trials, including NCT01068925, a drug interaction study with tipranavir/ritonavir in healthy volunteers, and NCT01227824, a Phase 3 trial comparing it to raltegravir. Other trials include NCT01231542 and NCT01332565.
Yes, GSK1349572 is also known as dolutegravir, sometimes abbreviated as DTG. One clinical trial, NCT01332565, explicitly refers to GSK1349572 as dolutegravir in its title.