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JNJ-47910382

Phase 1

Healthy Participants | Small molecule | Other |Johnson & Johnson|Last Updated: Jul 24, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-47910382 · 2 trials · 2 indications

Phase 1 2
NCT01662661A Study to Compare the Bioavailability of JNJ-47910382 Formulated as a Tablet and as Suspension in Healthy ParticipantsHealthy Participants
COMPLETED14 Analytics
NCT01482611A Study in Healthy Participants Investigating the Safety, Tolerability and Plasma Pharmacokinetics (PK) of Single Oral Doses of JNJ-47910382Hepatitis C Virus Infection
COMPLETED35 Analytics
PHASE1COMPLETED
A Study to Compare the Bioavailability of JNJ-47910382 Formulated as a Tablet and as Suspension in Healthy Participants
Healthy Participants
NCT0166266114
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PHASE1COMPLETED
A Study in Healthy Participants Investigating the Safety, Tolerability and Plasma Pharmacokinetics (PK) of Single Oral Doses of JNJ-47910382
Hepatitis C Virus Infection
NCT0148261135
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Study Endpoints

Primary Endpoints

Maximum plasma concentration (Cmax)
Day 1 (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0 hours), Day 2 (24, 36 hours), Day 3 (48 hours), and Day 4 (72 hours)
Time to reach the maximum plasma concentration (Tmax)
Day 1 (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0 hours), Day 2 (24, 36 hours), Day 3 (48 hours), and Day 4 (72 hours)
Area under the plasma concentration-time curve (AUC)
Day 1 (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0 hours), Day 2 (24, 36 hours), Day 3 (48 hours), and Day 4 (72 hours)
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

Number of participants with adverse events
Up to 58 days
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
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm ABEXPERIMENTALTreatment A: 200 mg dose of JNJ-47910382 formulated as a suspension followed by Treatment B: 200 mg JNJ-47910382 formulated as an uncoated tablet, administered on Day 1.
Arm BAEXPERIMENTALTreatment B: 200 mg JNJ-47910382 formulated as an uncoated tablet followed by Treatment A: 200 mg dose of JNJ-47910382 formulated as a suspension, administered on Day 1.
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-47910382 (suspension)DRUGType=exact number, unit=mg, number=200, form=suspension, route=oral. JNJ-47910382 administered on Day 1.
JNJ-47910382 (tablet)DRUGType=exact number, unit=mg, number=200, form=tablet, route=oral. JNJ-47910382 administered on Day 1.
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 to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Must be healthy on the basis of physical examination, medical history, vital signs and the results of blood biochemistry, hematology and coagulation tests and a urinalysis performed (at screening) * Must have a triplicate 12-lead electrocardiogram consistent with normal cardia...

Countries:BelgiumGermany
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Frequently asked questions about JNJ-47910382

What is JNJ-47910382 used for?

JNJ-47910382 is an investigational small molecule being studied for Hepatitis C Virus Infection and in healthy participants. It is being developed by Johnson & Johnson and is currently in Phase 1 clinical development. The drug is not approved and remains under investigation for safety, tolerability, and pharmacokinetics.

Who makes JNJ-47910382?

JNJ-47910382 is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company is conducting Phase 1 clinical trials to evaluate the drug's safety, tolerability, and pharmacokinetics in healthy participants and those with Hepatitis C Virus Infection.

What phase is JNJ-47910382 in?

JNJ-47910382 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one with 35 participants and another with 14 participants. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is JNJ-47910382 in?

JNJ-47910382 has been studied in two completed Phase 1 trials. NCT01482611 evaluated single oral doses in 35 healthy participants in Germany, and NCT01662661 compared tablet and suspension formulations in 14 healthy participants in Belgium. Both trials focused on safety, tolerability, and pharmacokinetics.

Is JNJ-47910382 the same as another drug?

JNJ-47910382 is the primary name for this investigational small molecule. No alternative names have been reported in the clinical trial data. It is being studied by Johnson & Johnson for Hepatitis C Virus Infection and in healthy participants.