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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01366547 | Relative Bioavailability Study of Two New Dolutegravir/Abacavir/Lamivudine Fixed Dose Combination Tablets | PHASE1 | COMPLETED | 18 | — | — | Jun 1, 2011 | Jul 1, 2011 | Aug 8, 2011 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Single Arm | EXPERIMENTAL | Subjects will be randomized in a three-way crossover design to receive a single dose of each of two different tablet formulations of dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg or dolutegravir 50 mg plus EPZICOM (abacavir 600mg/lamivudine 300 mg). There will be a screening visit within 30 days prior to first dose and a follow-up visit 7-14 days after the last dose. |
| Name | Type | Description |
|---|---|---|
| Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg | DRUG | Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg is an experimental fixed dose combination tablet of an experimental integrase inhibitor (dolutegravir) and two FDA approved nucleoside reverse transcriptase inhibitors (abacavir and lamivudine) |
| Dolutegravir 50 mg | DRUG | Dolutegravir is an experimental drug in the integrase inhibitor class that is being studied for the treatment of HIV infection. |
| abacavir 600 mg/lamivudine 300 mg | DRUG | This is an FDA approved fixed dose combination tablet of two nucleoside reverse transcriptase inhibitors |
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, at the time of signing the infor...