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Drug combination/ 26489112

Phase 1

Undisclosed | Small molecule | Other |Johnson & Johnson|Trials Updated: Apr 8, 2014

Drug combination/ 26489112 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2010

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Drug combination/ 26489112 clinical trials

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?

JNJ-26489112 is an investigational small molecule drug candidate developed by Johnson & Johnson. It has been studied in a Phase 1 pharmacokinetic and drug interaction trial in healthy adult volunteers. The specific therapeutic indication for JNJ-26489112 has not been publicly disclosed, and it remains in early clinical development.

Who is developing JNJ-26489112?

JNJ-26489112 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 1 pharmacokinetic and drug interaction study of JNJ-26489112 conducted in healthy volunteers in Belgium.

What phase is JNJ-26489112 in?

JNJ-26489112 is in Phase 1 clinical development. It has completed one Phase 1 trial, a pharmacokinetic and drug interaction study in healthy volunteers. No later-phase trials of JNJ-26489112 have been registered, and the compound is not approved for any indication.

What clinical trials is JNJ-26489112 in?

JNJ-26489112 has been evaluated in one registered clinical trial, NCT01147887, titled A Pharmacokinetic and Drug Interaction Study of JNJ-26489112 in Healthy Volunteers. That Phase 1 trial enrolled 20 healthy adult participants in Belgium and is completed. No active trials of JNJ-26489112 are currently listed.

What was the design of the JNJ-26489112 Phase 1 trial?

The Phase 1 trial of JNJ-26489112, NCT01147887, was an uncontrolled pharmacokinetic and drug interaction study conducted in healthy volunteers. It enrolled 20 participants of all sexes, aged 18 years and older, in Belgium. The study was not randomized and not double blinded, and it is now completed.