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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02466815 | A Study to Assess the Relative Bioavailability of JNJ-42756493 Tablets | PHASE1 | COMPLETED | 12 | — | — | Jun 1, 2015 | Aug 1, 2015 | Feb 3, 2025 | 1 | Belgium |
The Cmax is the maximum observed plasma JNJ-42756493 concentration. Relative bioavailability will be calculated by Cmax based on total drug concentrations.
AUC(0-24) is the area under the plasma JNJ-42756493 concentration-time curve from time 0 to 24 hours. Relative bioavailability will be calculated by AUC(0-24) based on total drug concentrations.
AUC(0-last) is the area under the plasma JNJ-42756493 concentration-time curve from time 0 to time of the last observed quantifiable concentration (Clast). Relative bioavailability will be calculated by AUC(0-last) based on total drug concentrations.
AUC (infinity) is the area under the plasma JNJ-42756493 concentration-time curve from time 0 to infinite time, calculated as the sum of AUC(0-last) and Clast/lambda(z), in which lambda(z) is the first-order rate constant associated with the terminal portion of the curve. Relative bioavailability will be calculated by AUC (infinity) based on total drug concentrations.
| Arm | Type | Description |
|---|---|---|
| Treatment A, then Treatment B and then Treatment C | EXPERIMENTAL | Participants will receive treatment A (JNJ-42756493 10 milligram \[mg\] tablet, current clinical formulation \[G-018\] which uses milled active pharmaceutical ingredient \[API\]) in period 1, treatment B (JNJ-42756493 10 mg tablet, Prototype Formulation I \[G-025\] which uses coarser API) in period 2 and then treatment C (JNJ-42756493 10 mg tablet, Prototype Formulation II \[G-025\] which uses coarser API) in period 3. |
| Treatment B, then Treatment C and then Treatment A | EXPERIMENTAL | Participants will receive treatment B in period 1, treatment C in period 2 and then treatment A in period 3. |
| Treatment C, then Treatment A and then Treatment B | EXPERIMENTAL | Participants will receive treatment C in period 1, treatment A in period 2 and then treatment B in period 3. |
| Treatment A, then Treatment C and then Treatment B | EXPERIMENTAL | Participants will receive treatment A in period 1, treatment C in period 2 and then treatment B in period 3. |
| Treatment B, then Treatment A and then Treatment C | EXPERIMENTAL | Participants will receive treatment B in period 1, treatment A in period 2 and then treatment C in period 3. |
| Treatment C, then Treatment B and then Treatment A | EXPERIMENTAL | Participants will receive treatment C in period 1, treatment B in period 2 and then treatment A in period 3. |
| Name | Type | Description |
|---|---|---|
| JNJ-42756493 Current Clinical Formulation (G-018) | DRUG | JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as current clinical formulation (G-018) in treatment A in either period 1, 2 or 3 as per treatment sequence. |
| JNJ-42756493 Prototype Formulation I (G-025) | DRUG | JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation I (G-025) in treatment B in either period 1, 2 or 3 as per treatment sequence. |
| JNJ-42756493 Prototype Formulation II (G-025) | DRUG | JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation II (G-025) in treatment C in either period 1, 2 or 3 as per treatment sequence. |
Inclusion Criteria: * Participants should be willing to adhere to the prohibitions and restrictions specified in this protocol * Woman must be either: postmenopausal (greater than (\>) 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum...