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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00411190 | Study To Determine The Effects Of Doses Of Relacatib On The Metabolism Of Acetaminophen, Ibuprofen And Atorvastatin | PHASE1 | COMPLETED | 32 | — | — | Oct 19, 2006 | Dec 15, 2006 | Oct 4, 2017 | 2 | Belgium |
| Arm | Type | Description |
|---|---|---|
| Session 1 | EXPERIMENTAL | Subjects will receive 500 mg acetaminophen on Day 1, 400 mg ibuprofen on Day 2, 40 mg atorvastatin on Day 3. |
| Session 2 | EXPERIMENTAL | Subjects will be randomized to receive relacatib 60 mg or 120 mg from Day 1-14. On Day 15 subjects will receive 500 mg acetaminophen, 400 mg ibuprofen on Day 16 and 40 mg atorvastatin on Day 17 with usual dose of relacatib. |
| Name | Type | Description |
|---|---|---|
| Relacatib | DRUG | Subjects will administer 60 or 120 mg tablets in Session 2 |
| Acetaminophen | DRUG | Acetaminophen will be administered orally |
| Ibuprofen | DRUG | Ibuprofen will be administered orally |
| Atorvastatin | DRUG | Atorvastatin will be administered orally |
Inclusion Criteria: * Healthy * Postmenopausal * Body weight \> 50 kg * Body mass index (BMI) between 19 and 30 * The subject is willing and able to give a signed and dated written informed consent prior to admission to the study * The subject is able to understand and comply with protocol requirem...