HealthyPhase 1NCT01147887
A Pharmacokinetic and Drug Interaction Study of JNJ-26489112 in Healthy Volunteers
A Phase 1 study testing Drug combination/ 26489112 in people with Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Drug combination/ 26489112
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2010to Aug 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study to Assess the Effect of Multiple-Dose JNJ26489112 on the Cytochrome P450 Enzymes Using a 3-Probe Substrate Drug Combination in Healthy Subjects
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.
Read the detailed description
26489112 is a drug that is being tested to see if it may be useful for a number of indications including major depression. This study will compare the effects of 26489112 administered to healthy volunteers alone or in combination with a mixture of 3 drugs consisting of midazolam (a drug used for reducing anxiety or producing drowsiness or anesthesia before certain medical procedures or surgery), omeprazole (a drug used to treat symptoms of gastroesophageal reflux disease (GERD) or other conditions caused by excess stomach acid), and tolbutamide (a drug used for treating type 2 diabetes mellitus in patients when blood sugar cannot be controlled by diet and exercise alone). Approximately 20 healthy adult volunteers will be enrolled and will be treated with study drug for 22 days. Volunteers will be required to stay overnight at the study center to receive study treatment for 4 nights at the beginning of the study and for 4 nights towards the end of the study. On all other occasions, volunteers will make daily visits to the study center to receive treatment with study drug. Participants will take a combination of 3 drugs (omeprazole 20 mg capsule, tolbutamide 500 mg tablet, and midazolam 2mg/mL liquid) orally (by mouth) or 2 tablets of study drug (2648911) orally with 1 cup of water. Blood samples will be collected from study participants at protocol-specified times during the study to determine the concentration of each of the 4 drugs (26489112, midazolam, omeprazole, and tolbutamide) present in plasma (the colorless fluid portion of blood). In addition, a blood sample will be obtained from all enrolled patients before study drug administration for pharmacogenomics research (research to help identify genetic markers of response, to explain variability in the data, or to address emerging clinical issues). The primary outcome measure is the concentration of midazolam, omeprazole, tolbutamide, and 26489112 in plasma measured by protocol-specified pharmacokinetic parameters at protocol-specified time points on Days 1-4 and Dasy 19-22. Safety will be monitored during the study. Healthy volunteers will receive study drug (26489112) orally (by mouth) in the morning from Day 4 through Day 21.
- Conditions
- Healthy
- Being tested
- Drug combination/ 26489112
- Keywords
- 26489112, Omeprazole, Tolbutamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug combination/ 26489112Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Drug combination/ 26489112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concentration of midazolam, omeprazole, tolbutamide, and 26489112 in plasma measured by protocol-specified pharmacokinetic parameters
Measured: Days 1-4 and Days 19-22
Secondary outcomes (4)
The number of patients with adverse events as a measure of safety.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From screening to the end of the study (Day 22) or at the time of early withdrawal from the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJun 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147887
- Sponsor's protocol ID
- CR017176
- Other IDs
- 26489112MDD1002
- Status last verified
- Apr 2014
- First submitted
- 17 Jun 2010
- Last updated
- 8 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Assess the Effect of Multiple-Dose JNJ26489112 on the Cytochrome P450 Enzymes Using a 3-Probe Substrate Drug Combination in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01147887
- Acronym / sponsor ID
- CR017176
- Conditions
- Healthy
- Keywords
- 26489112, Omeprazole, Tolbutamide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Study completion
- Aug 2010 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
26489112 is a drug that is being tested to see if it may be useful for a number of indications including major depression. This study will compare the effects of 26489112 administered to healthy volunteers alone or in combination with a mixture of 3 drugs consisting of midazolam (a drug used for reducing anxiety or producing drowsiness or anesthesia before certain medical procedures or surgery), omeprazole (a drug used to treat symptoms of gastroesophageal reflux disease (GERD) or other conditions caused by excess stomach acid), and tolbutamide (a drug used for treating type 2 diabetes mellitus in patients when blood sugar cannot be controlled by diet and exercise alone). Approximately 20 healthy adult volunteers will be enrolled and will be treated with study drug for 22 days. Volunteers will be required to stay overnight at the study center to receive study treatment for 4 nights at the beginning of the study and for 4 nights towards the end of the study. On all other occasions, volunteers will make daily visits to the study center to receive treatment with study drug. Participants will take a combination of 3 drugs (omeprazole 20 mg capsule, tolbutamide 500 mg tablet, and midazolam 2mg/mL liquid) orally (by mouth) or 2 tablets of study drug (2648911) orally with 1 cup of water. Blood samples will be collected from study participants at protocol-specified times during the study to determine the concentration of each of the 4 drugs (26489112, midazolam, omeprazole, and tolbutamide) present in plasma (the colorless fluid portion of blood). In addition, a blood sample will be obtained from all enrolled patients before study drug administration for pharmacogenomics research (research to help identify genetic markers of response, to explain variability in the data, or to address emerging clinical issues). The primary outcome measure is the concentration of midazolam, omeprazole, tolbutamide, and 26489112 in plasma measured by protocol-specified pharmacokinetic parameters at protocol-specified time points on Days 1-4 and Dasy 19-22. Safety will be monitored during the study. Healthy volunteers will receive study drug (26489112) orally (by mouth) in the morning from Day 4 through Day 21.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: Drug combination/ 26489112Drug 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug combination/ 26489112On 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 | 001 |
Primary outcome
The concentration of midazolam, omeprazole, tolbutamide, and 26489112 in plasma measured by protocol-specified pharmacokinetic parameters
Time frame: Days 1-4 and Days 19-22
4 secondary outcomes
The number of patients with adverse events as a measure of safety.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From screening to the end of the study (Day 22) or at the time of early withdrawal from the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Drug combination/ 26489112 in people with Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The concentration of midazolam, omeprazole, tolbutamide, and 26489112 in plasma measured by protocol-specified pharmacokinetic parameters (time frame: Days 1-4 and Days 19-22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2014.