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JNJ-47910382

Phase 1

Hepatitis C Virus Infection | Small molecule | Infectious Disease |Johnson & Johnson|Last Updated: Feb 20, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01482611A Study in Healthy Participants Investigating the Safety, Tolerability and Plasma Pharmacokinetics (PK) of Single Oral Doses of JNJ-47910382PHASE1 COMPLETED 35 — — Nov 1, 2011Apr 1, 2012Feb 20, 20131 Germany
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Study Endpoints
Primary Endpoints
Percentage of participants with adverse events as a measure of safety and tolerability of JNJ-47910382 for each dose tested.
As of Day1 till and including 30-35 days after last drug intake

Adverse Events (AEs) with onset during the treatment phase and AEs that have worsened since baseline will be analysed.

PK parameters after increasing single oral doses of JNJ-47910382, from 10 mg up to the maximum tolerated dose or up to 600 mg or up to the dose that yields a plasma level that approaches the predefined maximum mean exposure of JNJ-47910382.
Measured on Day1 till and including Day5 (i.e. predose, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h post dose) in each session.

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.

Change from baseline values for clinical laboratory parameters for each dose group.
On Day1, 2 and 4 during treatment, on Day of drop-out (i.e. from day of dosing in first session till 96h postdosing in last session) and on both Follow up visits (i.e. 10-14 days after last drug intake and 30-35 days after last drug intake).
Change from baseline values for ECG for each dose group.
On Day-1, 1, 2, 3 and 4 during treatment and on Day of drop-out (i.e. from day of dosing in first session till 96h postdosing in last session)..
Change from baseline values for vital signs for each dose group.
On Day1, 2, 3 and 4 during treatment and on Day of drop-out (i.e. from day of dosing in first session till 96h postdosing in last session) and on both Follow up visits (i.e. 10-14 days after last drug intake and 30-35 days after last drug intake).
Change from baseline values for physical examination for each dose group.
On Day-1, 4, Day of drop-out (i.e. from day of dosing in first session till 96h postdosing in last session) and on both Follow up visits (i.e. 10-14 days after last drug intake and 30-35 days after last drug intake).
Change from baseline values for cardia telemetry for each dose group.
Day1 (12 hours post-dose)
Secondary Endpoints
Sequencing of genes that may affect safety, tolerability or PK of JNJ-47910382.
Per participant, once during the conduct of the study, preferentially on Day-2 of one of the sessions.
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Panel 1: CaucasianEXPERIMENTAL10, 75 and 300 mg JNJ-47910382 or placebo
Panel 2: CaucasianEXPERIMENTAL30, 150, 600 mg JNJ-47910382 or placebo
Panel 3: JapaneseEXPERIMENTALSession VIII and X: Doses of JNJ-47910382 or placebo to be determined
Panel 4: JapaneseEXPERIMENTALSession IX: Dose of JNJ-47910382 or placebo to be determined
Interventions
NameTypeDescription
JNJ-47910382DRUGType = exact number, unit = mg, number = 10, 75, 300, form = suspension, route = oral use.
PlaceboDRUGType = exact number, unit = mg, number = equivalent of 10, 75, 300, form = suspension, route = oral use.
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:Germany
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