Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Formulation 2 · 1 trial · 1 indication
The Cmax is the maximum observed plasma concentration.
The tmax is time to reach the maximum observed plasma concentration.
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
| Arm | Type | Description |
|---|---|---|
| Group 1 (Formulation 2 Then Formulation 1) | EXPERIMENTAL | Single-dose of JNJ-54781532 formulation 2 will be administered as 150 milligram (mg) oral tablet in first treatment period; followed by JNJ-54781532 formulation 1 as 150 mg orally (5\*30 mg tablet=150 mg) in second treatment period. A washout period of at least 7 days will be maintained between each treatment period. |
| Group 2 (Formulation 1 Then Formulation 2) | EXPERIMENTAL | Single-dose of JNJ-54781532 formulation 1 will be administered as 150 mg oral tablet (5\*30 mg tablet=150 mg) in first treatment period; followed by JNJ-54781532 formulation 2 as 150 mg oral tablet in second treatment period. A washout period of at least 7 days will be maintained between each treatment period. |
| Name | Type | Description |
|---|---|---|
| Formulation 2 | DRUG | Single-dose of JNJ-54781532 formulation 2 will be administered as 150 milligram (mg) oral tablet in one of the treatment periods. |
| Formulation 1 | DRUG | Single-dose of JNJ-54781532 formulation 1 will be administered as 150 milligram (mg) oral tablet (5\*30 mg tablet=150 mg) in one of the treatment periods. |
Inclusion Criteria: * Female participants must be either: 1) not of childbearing potential: postmenopausal or surgically sterile at screening 2) of child-bearing potential: Must use highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting ...
Formulation 2 is an investigational small molecule being studied in healthy participants and in patients with relapsed or refractory Hodgkin Lymphoma. It is developed by Johnson & Johnson (JNJ) and is currently in Phase 1 clinical development.
Formulation 2 is developed by Johnson & Johnson, traded on the New York Stock Exchange under the ticker JNJ. The company is conducting Phase 1 trials to evaluate the drug in healthy participants and in patients with relapsed or refractory Hodgkin Lymphoma.
Formulation 2 is in Phase 1 clinical development. It is an investigational drug, not yet approved by the FDA. It has received FDA designations including Breakthrough Therapy, Fast Track, and Priority Review.
Formulation 2 has one completed Phase 1 trial, NCT01572519, which studied JNJ-40346527 in 21 patients with relapsed or refractory Hodgkin Lymphoma in France and Germany. Another completed trial, NCT02117505, evaluated the relative bioavailability of two tablet formulations in 20 healthy adults in Belgium.
Formulation 2 is associated with the compound JNJ-40346527, which was studied in the Phase 1 trial NCT01572519 for relapsed or refractory Hodgkin Lymphoma. The drug is also linked to JNJ-54781532, which was evaluated in a bioavailability study in healthy participants.