Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-42756493 Current Clinical Formulation · 1 trial · 1 indication
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...
JNJ-42756493 Current Clinical Formulation is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is currently in clinical development for research purposes only.
Johnson & Johnson (NYSE: JNJ) is developing JNJ-42756493 Current Clinical Formulation. The company conducted a Phase 1 clinical trial to assess the relative bioavailability of the drug.
JNJ-42756493 Current Clinical Formulation is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials.
JNJ-42756493 Current Clinical Formulation was studied in one completed Phase 1 trial, NCT02466815, titled "A Study to Assess the Relative Bioavailability of JNJ-42756493 Tablets." The trial enrolled 12 healthy participants in Belgium.
JNJ-42756493 Current Clinical Formulation is a specific formulation of the drug JNJ-42756493. The clinical trial NCT02466815 assessed the relative bioavailability of JNJ-42756493 tablets, indicating that this formulation is being evaluated for how the drug is absorbed.