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Drug combination/ 26489112

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Drug combination/ 26489112 · 1 trial · 1 indication

Phase 1 1
NCT01147887A Pharmacokinetic and Drug Interaction Study of JNJ-26489112 in Healthy VolunteersHealthy
COMPLETED20 Analytics
PHASE1COMPLETED
A Pharmacokinetic and Drug Interaction Study of JNJ-26489112 in Healthy Volunteers
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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
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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.
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Eligibility Criteria

Age Range18 Years to 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
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Frequently asked questions about Drug combination/ 26489112

What is JNJ-26489112 used for?

JNJ-26489112 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in early clinical development. The only completed trial assessed its pharmacokinetics and drug interactions in healthy adults, indicating it is being evaluated for safety and how the body processes it.

Who makes JNJ-26489112?

JNJ-26489112 is being developed by Johnson & Johnson, traded on the New York Stock Exchange under the ticker JNJ. The company sponsored a Phase 1 study of the drug in healthy volunteers, which has been completed.

What phase is JNJ-26489112 in?

JNJ-26489112 is in Phase 1 clinical development. The single trial, NCT01147887, was a Phase 1 study that has been completed. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is JNJ-26489112 in?

JNJ-26489112 has one completed clinical trial, NCT01147887, titled "A Pharmacokinetic and Drug Interaction Study of JNJ-26489112 in Healthy Volunteers." This Phase 1 study enrolled 20 healthy adults in Belgium and was not randomized, double-blind, or controlled.

Is JNJ-26489112 FDA approved?

JNJ-26489112 is not FDA approved. It is an investigational drug that has only been studied in a completed Phase 1 trial in healthy volunteers. No efficacy trials in patients have been conducted, and the drug remains in early clinical development.