Recent Updates
Recently added Catalysts

Drug combination/ 26489112

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Apr 8, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01147887A Pharmacokinetic and Drug Interaction Study of JNJ-26489112 in Healthy VolunteersPHASE1 COMPLETED 20 — — Jun 1, 2010Aug 1, 2010Apr 8, 20141 Belgium
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
The concentration of midazolam, omeprazole, tolbutamide, and 26489112 in plasma measured by protocol-specified pharmacokinetic parameters
Days 1-4 and Days 19-22
Secondary Endpoints
The number of patients with adverse events as a measure of safety.
From screening to the end of the study (Day 22) or at the time of early withdrawal from the study
Results from clinical laboratory tests including blood glucose levels as a measure of safety.
From screening to the end of the study (Day 22) or at the time of early withdrawal from the study
Findings from ECGs and vital sign measurements as a measure of safety.
From screening to the end of the study (Day 22) or at the time of early withdrawal from the study
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
001EXPERIMENTALDrug combination/ 26489112 On Day 1 and on Day 19 a single oral dose of a drug combination consisting of midazolam (2 mg/mL liquid) tolbutamide (a 500 mg tablet) and omeprazole (a 20 mg capsule) will be taken and on Day 4 through Day 21 a single oral dose of two 26489112 tablets will be taken.
Interventions
NameTypeDescription
Drug combination/ 26489112DRUGOn Day 1 and on Day 19, a single, oral dose of a drug combination consisting of midazolam (2 mg/mL liquid), tolbutamide (a 500 mg tablet), and omeprazole (a 20 mg capsule) will be taken and on Day 4 through Day 21, a single oral dose of two 26489112 tablets will be taken.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * If a woman, must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., intrauterine device, double-barrier method, male partner sterilization) before entr...

Countries:Belgium
Unlock Eligibility Criteria