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Also known as JNJ-47910382 (suspension)
JNJ-47910382 · 1 trial · 1 indication
Adverse Events (AEs) with onset during the treatment phase and AEs that have worsened since baseline will be analysed.
PK characteristics of JNJ-47910382 are determined based on plasma levels at one time point (Day3, 4 and 5), at 2 time points (Day2) and at 11 time points (Day1). Standard PK parameters such as Cmax (maximal concentration), Tmax (time point at moment maximal concentration is reached), AUClast (Area Under the Curve from time point of drug administration up to the last time point with a measurable concentration post dosing) etc. will be determined.
| Arm | Type | Description |
|---|---|---|
| Panel 1: Caucasian | EXPERIMENTAL | 10, 75 and 300 mg JNJ-47910382 or placebo |
| Panel 2: Caucasian | EXPERIMENTAL | 30, 150, 600 mg JNJ-47910382 or placebo |
| Panel 3: Japanese | EXPERIMENTAL | Session VIII and X: Doses of JNJ-47910382 or placebo to be determined |
| Panel 4: Japanese | EXPERIMENTAL | Session IX: Dose of JNJ-47910382 or placebo to be determined |
| Name | Type | Description |
|---|---|---|
| JNJ-47910382 | DRUG | Type = exact number, unit = mg, number = 10, 75, 300, form = suspension, route = oral use. |
| Placebo | DRUG | Type = exact number, unit = mg, number = equivalent of 10, 75, 300, form = suspension, route = oral use. |
Inclusion Criteria: * Caucasian subjects between 18 and 45 years of age, inclusive. * Japanese subjects between 20 and 45 years of age, inclusive. * MALE Japanese subjects who has resided outside of Japan for no more than 5 years and whose parents and maternal and paternal grandparents are Japanese...
JNJ-47910382 is an investigational small molecule developed by Johnson & Johnson for hepatitis C virus infection. It is a Phase 1 candidate that has been studied in a single completed clinical trial in healthy participants. The compound is also referred to as JNJ-47910382 (suspension).
JNJ-47910382 is being developed for the treatment of hepatitis C virus infection. The only clinical trial conducted to date evaluated the drug in healthy adult participants rather than in patients with hepatitis C, so its use in the target indication remains under investigation.
JNJ-47910382 is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 1 study of the compound conducted in Germany.
JNJ-47910382 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved for any indication.
JNJ-47910382 has been evaluated in one completed Phase 1 trial, NCT01482611, titled a study in healthy participants investigating the safety, tolerability and plasma pharmacokinetics of single oral doses of JNJ-47910382. The trial enrolled 35 participants in Germany and was randomized, double-blind, and controlled.
Yes, JNJ-47910382 (suspension) is an alternative name for JNJ-47910382. The suspension refers to the oral formulation used in the Phase 1 study of the compound.