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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01288755 | TMC278-TiDP6-C153 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC278 and Raltegravir | PHASE1 | COMPLETED | 24 | — | — | Feb 1, 2011 | May 1, 2011 | Jun 27, 2011 | - | — |
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | TMC278 One 25 mg tablet once daily for 11 days (TrtA and C) |
| 002 | EXPERIMENTAL | Raltegravir One 400 mg tablet twice daily for 4 days (Trt B) and for 11 days (TrtC) |
| Name | Type | Description |
|---|---|---|
| TMC278 | DRUG | One 25 mg tablet, once daily, for 11 days (TrtA and C) |
| Raltegravir | DRUG | One 400 mg tablet, twice daily, for 4 days (Trt B) and for 11 days (TrtC) |
Inclusion Criteria: * Healthy, based on physical examination, medical history, vital signs, ECG, blood biochemistry, hematology and urinalysis * Body Mass Index of 18 to 30.0 kg/m2 * Non-smoking for at least 3 months prior to screening * Women must be postmenopausal for at least 2 years, or be surg...