A Pharmacokinetic and Drug Interaction Study of JNJ-26489112 in Healthy Volunteers

NCT01147887 | Completed Phase 1

• 2 other identifiers: CR01717626489112MDD1002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of 26489112 on the pharmacokinetics (blood levels) of a combination of 3 drugs administered to healthy volunteers.

Conditions

Healthy

Keywords

26489112; Omeprazole; Tolbutamide

Outcome Measures

Primary Outcomes (1)

• The concentration of midazolam, omeprazole, tolbutamide, and 26489112 in plasma measured by protocol-specified pharmacokinetic parameters

  Days 1-4 and Days 19-22

Secondary Outcomes (4)

• 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

• Findings from physical and neurologic examinations performed 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

Study Arms (1)

001

EXPERIMENTAL

Drug 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.

Drug: Drug combination/ 26489112

Interventions

Drug combination/ 26489112 DRUG

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.

001

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 entry and throughout the study and must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening
• If a man, must agree to use an adequate contraception method as deemed appropriate by the investigator (e.g., vasectomy at least 6 months before study entry, double barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
• Body mass index (BMI
• weight \[kg\]/height \[m\]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
• Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic and results from a 12-lead electrocardiogram (ECG) that are consistent with normal cardiac conduction and function
• Nonsmoker for at least 6 months

You may not qualify if:

• History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease including current suicidal ideation or behavior, infection, known history of G6PD deficiency, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
• Known clinically significant ophthalmologic examination results or known ocular deficits, including retinal disorders
• History of clinically significant allergies, known allergy to the study drug or any of the excipients of the formulation, or known allergy to heparin or history of heparin-induced thrombocytopenia

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

MeSH Terms

Interventions

Drug Combinations

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2010
• First Posted: June 22, 2010
• Study Start: June 1, 2010
• Study Completion: August 1, 2010
• Last Updated: April 8, 2014

Record last verified: 2014-04

Locations

BE (1)