Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-39439335 · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Japanese Group 1: JNJ-39439335/placebo (Part 1) | EXPERIMENTAL | - |
| Japanese Group 2: JNJ-39439335/placebo (Part 1) | EXPERIMENTAL | - |
| Japanese Group 3: JNJ-39439335/placebo (Part 1) | EXPERIMENTAL | - |
| Caucasian Group 1: JNJ-39439335/placebo (Part 1) | EXPERIMENTAL | - |
| Caucasian Group 2: JNJ-39439335/placebo (Part 1) | EXPERIMENTAL | - |
| Caucasian Group 3: JNJ-39439335/placebo (Part 1) | EXPERIMENTAL | - |
| Japanese Group 1: JNJ-39439335/placebo (Part 2) | EXPERIMENTAL | - |
| Japanese Group 2: JNJ-39439335/placebo (Part 2) | EXPERIMENTAL | - |
| Japanese Group 3: JNJ-39439335/placebo (Part 2) | EXPERIMENTAL | - |
| 001 | EXPERIMENTAL | JNJ-39439335 Part 1:Type=1 unit=mg number=25 form=capsule route=oral use. One capsule (25 mg/day) taken once on Day 1 in 3 treatment periods. or Part 1:Type=2 unit=mg number=12.5 form=capsule route=oral use. Two capsules (25 mg/day) taken once on Day 1 in 3 treatment periods.,JNJ-39439335 Part 2:Type=2 unit=mg number=12.5 form=capsule route=oral use. Two capsules taken (25 mg/day) once on Day 1 in 2 treatment periods. |
| 002 | EXPERIMENTAL | JNJ-39439335 2 x 25 mg tablets once daily for 21 days |
| 003 | OTHER | Naproxen 500 mg capsule every 12 hours for 21 days |
| 004 | PLACEBO_COMPARATOR | Placebo Placebo tablet/capsule every 12 hours for 21 days |
| Name | Type | Description |
|---|---|---|
| JNJ-39439335 10 mg | DRUG | Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg. |
| JNJ-39439335 25 mg | DRUG | Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg. |
| JNJ-39439335 50 mg | DRUG | Multiple (once daily for 21 days) oral doses of JNJ-39439335 50 mg. |
| Placebo | DRUG | Multiple (once daily for 21 days) oral doses of matching placebo. |
| JNJ-39439335 | DRUG | Part 2:Type=2, unit=mg, number=12.5, form=capsule, route=oral use. Two capsules taken (25 mg/day) once on Day 1 in 2 treatment periods. |
| Naproxen | DRUG | 500 mg capsule every 12 hours for 21 days |
Inclusion Criteria: * Japanese or Caucasian participants * Nonsmoker * Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive, and body weight not less than 50 kg * Healthy on the basis of a physical examination, vital signs, hematology, coagulation, serum chemistry (including liver function tests) and...
JNJ-39439335 is an investigational small molecule being studied for osteoarthritis of the knee and in healthy volunteers. It is in Phase 1 clinical development, meaning it has not been approved and is still being tested for safety and tolerability.
JNJ-39439335 is being developed by Johnson & Johnson, traded on the New York Stock Exchange under the ticker JNJ. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and pharmacokinetics.
JNJ-39439335 is in Phase 1 clinical development. All three of its clinical trials have been completed, with a total enrollment of 129 participants. It is an investigational drug and has not received FDA approval.
JNJ-39439335 has completed three Phase 1 trials: NCT01343303 in patients with knee osteoarthritis in South Africa, NCT01454245 in healthy adult males in the United States, and NCT01631487 comparing healthy Japanese and Caucasian males in the United States.
No alternative names for JNJ-39439335 have been disclosed. It is identified solely by its compound number in clinical trial registrations and is being studied as a small molecule for osteoarthritis and healthy volunteer studies.