HealthyPhase 1NCT01986491
A Study of Solid Formulations of JNJ-39393406 in Healthy Male Participants
A Phase 1 study testing JNJ 39393406 30 mg solid X, JNJ 39393406 30 mg solid Y and JNJ 39393406 120 mg solid X in people with Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in Belgium.
Trial summary
The purpose of the study is to compare the pharmacokinetics (what a medication does to the body), dose-proportionality, safety and tolerability of JNJ 39393406 following single dose oral administration of two solid oral formulations in Part 1; based on the profile in Part 1, one of the formulations assessed will be… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ 39393406 30 mg solid X, JNJ 39393406 30 mg solid Y and JNJ 39393406 120 mg solid X
- 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
- May 2009to Aug 2009
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male participants
- Body mass index (BMI) between 18 and 30 kg/m2 (BMI is calculated as weight [kilogram] divided by square of height [meter])
- Willing to adhere to the prohibitions and restrictions specified in the protocol
- Must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Who cannot join
- Clinically significant abnormal values for clinical chemistry, hematology or urinalysis at screening or admission
- Clinically significant abnormal physical examination, neurological examination, vital signs or 12 lead electrocardiogram at screening
- Significant history of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, bronchospastic respiratory disease, dyspnea, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, infection, or any other illness that the investigator considers clinically significant
- Significant history of or current psychiatric or neurological illness
- Serology positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus antibodies at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single Dose, Relative Bioavailability Study of Solid Formulations in Fed and Fasted Conditions Followed by a Repeated Dose Study of a Selected Solid Formulation of JNJ-39393406 in Healthy Male Subjects
The purpose of the study is to compare the pharmacokinetics (what a medication does to the body), dose-proportionality, safety and tolerability of JNJ 39393406 following single dose oral administration of two solid oral formulations in Part 1; based on the profile in Part 1, one of the formulations assessed will be selected to investigate the pharmacokinetics in fasting condition in Part 2 and after repeated dosing in Part 3.
Read the detailed description
This is an open-label (all people know the identity of the intervention) and single center study that will be conducted in 3 parts (Part 1, Part 2, and Part 3). The study consists of 3 phases including, the screening phase, treatment phase, and the follow-up phase. Part 1 is a four-way cross-over (method used to switch participants from one treatment arm to another in a clinical study) study to compare the pharmacokinetics, dose-proportionality, safety and tolerability of JNJ 39393406 following single dose oral administration of two solid oral formulations (X and Y). Approximately 12 participants will be enrolled in Part 1. Part 2 is two-way cross-over study in a separate group of participants to assess pharmacokinetics in fasting condition and the relative bioavailability (the extent to which a medication or other substance becomes available to the body) of the selected solid formulation from Part 1 compared with a solution formulation. Approximately 8 participants will be enrolled in Part 2. In Part 3, the single and repeated dose pharmacokinetics after administration of the selected formulation from Part 1 will be assessed for 7 consecutive days. The same participants will participate in Parts 2 and 3 of the study. Safety will be evaluated by the assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, physical examination, and neurological examination. The duration of participation in the study for an individual participant will be approximately 8 weeks (including screening and follow up visit).
- Conditions
- Healthy
- Being tested
- JNJ 39393406 30 mg solid X, JNJ 39393406 30 mg solid Y, JNJ 39393406 120 mg solid X, JNJ 39393406 120 mg solid Y, JNJ 39393406 30 mg solution
- Keywords
- Healthy, JNJ-39393406, Relative Bioavailability, Solid Formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ 39393406 30 mg solid XDrug
Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
JNJ 39393406 30 mg solid YDrug
Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
JNJ 39393406 120 mg solid XDrug
Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
JNJ 39393406 120 mg solid YDrug
Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
JNJ 39393406 30 mg solutionDrug
Participants will receive JNJ 39393406 30 mg/mL solution orally (by mouth).
| Study group | Role | What they receive |
|---|---|---|
| Part 1; Period 1 | Experimental | Three participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks. 30 mg of solid X, 120 mg of solid Y, 30 mg of solid Y, and 120 mg of solid X. Receives: Drug: JNJ 39393406 30 mg solid X; Drug: JNJ 39393406 30 mg solid Y; Drug: JNJ 39393406 120 mg solid X; Drug: JNJ 39393406 120 mg solid Y |
| Part 1; Period 2 | Experimental | Three participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks. 30 mg of solid Y, 30 mg of solid X, 120 mg of solid X and 120 mg of solid Y. Receives: Drug: JNJ 39393406 30 mg solid X; Drug: JNJ 39393406 30 mg solid Y; Drug: JNJ 39393406 120 mg solid X; Drug: JNJ 39393406 120 mg solid Y |
| Part 1; Period 3 | Experimental | Three participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 120 mg of solid X, 30 mg of solid Y, 120 mg of solid Y, and 30 mg of solid X. Receives: Drug: JNJ 39393406 30 mg solid X; Drug: JNJ 39393406 30 mg solid Y; Drug: JNJ 39393406 120 mg solid X; Drug: JNJ 39393406 120 mg solid Y |
| Part 1; Period 4 | Experimental | Three participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 120 mg of solid Y, 120 mg of solid X, 30 mg of solid X, and 30 mg of solid Y. Receives: Drug: JNJ 39393406 30 mg solid X; Drug: JNJ 39393406 30 mg solid Y; Drug: JNJ 39393406 120 mg solid X; Drug: JNJ 39393406 120 mg solid Y |
| Part 2; Period 1 | Experimental | Four participants will receive 30 mg of JNJ 39393406 of 2 different formulations (solid formulation selected from Part 1 and solution) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 30 mg of solid formulation, and 30 mg of solution. Receives: Drug: JNJ 39393406 30 mg solid X; Drug: JNJ 39393406 30 mg solid Y; Drug: JNJ 39393406 120 mg solid X; Drug: JNJ 39393406 120 mg solid Y; Drug: JNJ 39393406 30 mg solution |
| Part 2; Period 2 | Experimental | Four participants will receive 30 mg of JNJ 39393406 of 2 different formulations (solid formulation selected from Part 1 and solution) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 30 mg of solution, and 30 mg of solid formulation. Receives: Drug: JNJ 39393406 30 mg solid X; Drug: JNJ 39393406 30 mg solid Y; Drug: JNJ 39393406 120 mg solid X; Drug: JNJ 39393406 120 mg solid Y; Drug: JNJ 39393406 30 mg solution |
| Part 3 | Experimental | Eight participants (same participants from Part 2) will receive JNJ 39393406 (dose will likely be 30 mg, or another multiple of the 30 mg solid dose form selected in Part 1, but not higher than 210 mg) from Days 1 to 7. Receives: Drug: JNJ 39393406 30 mg solid X; Drug: JNJ 39393406 30 mg solid Y |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration of JNJ 39393406
Maximum plasma concentration of JNJ 39393406, determined by visual inspection of the data
Measured: Predose to 96 hrs postdose (Part 1 and Part 2 [after each single-dose administration]); predose to 24 hrs postdose (Day 1); predose to 5 hrs postdose (Days 3 and 5); predose to 96 hrs (Day 8), and end of study (7 to 14 days after the last dose) (Part 3)
Time to reach the maximum plasma concentration of JNJ 39393406
Time to reach the maximum plasma concentration, determined by visual inspection of the data
Measured: Predose to 96 hrs postdose (Part 1 and Part 2 [after each single-dose administration]); predose to 24 hrs postdose (Day 1); predose to 5 hrs postdose (Days 3 and 5); predose to 96 hrs (Day 8), and end of study (7 to 14 days after the last dose) (Part 3)
Area under the plasma concentration-time curve of JNJ-39393406
Measured: Predose to 96 hrs postdose (Part 1 and Part 2 [after each single-dose administration]); predose to 24 hrs postdose (Day 1); predose to 5 hrs postdose (Days 3 and 5); predose to 96 hrs (Day 8), and end of study (7 to 14 days after the last dose) (Part 3
Number of participants with adverse events
Measured: Up to 7 to 14 days after last dose of study medication (Part 1, Part 2, and Part 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startMay 2009
- Primary completionAug 2009
- Study completionAug 2009
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986491
- Sponsor's protocol ID
- CR016264
- Other IDs
- 39393406EDI1003
- Status last verified
- Nov 2013
- First submitted
- 11 Nov 2013
- Last updated
- 18 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single Dose, Relative Bioavailability Study of Solid Formulations in Fed and Fasted Conditions Followed by a Repeated Dose Study of a Selected Solid Formulation of JNJ-39393406 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01986491
- Acronym / sponsor ID
- CR016264
- Conditions
- Healthy
- Keywords
- Healthy, JNJ-39393406, Relative Bioavailability, Solid Formulation
- 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
- May 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 18 Nov 2013 (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 the study is to compare the pharmacokinetics (what a medication does to the body), dose-proportionality, safety and tolerability of JNJ 39393406 following single dose oral administration of two solid oral formulations in Part 1; based on the profile in Part 1, one of the formulations assessed will be selected to investigate the pharmacokinetics in fasting condition in Part 2 and after repeated dosing in Part 3.
Detailed description
This is an open-label (all people know the identity of the intervention) and single center study that will be conducted in 3 parts (Part 1, Part 2, and Part 3). The study consists of 3 phases including, the screening phase, treatment phase, and the follow-up phase. Part 1 is a four-way cross-over (method used to switch participants from one treatment arm to another in a clinical study) study to compare the pharmacokinetics, dose-proportionality, safety and tolerability of JNJ 39393406 following single dose oral administration of two solid oral formulations (X and Y). Approximately 12 participants will be enrolled in Part 1. Part 2 is two-way cross-over study in a separate group of participants to assess pharmacokinetics in fasting condition and the relative bioavailability (the extent to which a medication or other substance becomes available to the body) of the selected solid formulation from Part 1 compared with a solution formulation. Approximately 8 participants will be enrolled in Part 2. In Part 3, the single and repeated dose pharmacokinetics after administration of the selected formulation from Part 1 will be assessed for 7 consecutive days. The same participants will participate in Parts 2 and 3 of the study. Safety will be evaluated by the assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, physical examination, and neurological examination. The duration of participation in the study for an individual participant will be approximately 8 weeks (including screening and follow up visit).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part 1; Period 1 | Experimental | Drug: JNJ 39393406 30 mg solid X, Drug: JNJ 39393406 30 mg solid Y, Drug: JNJ 39393406 120 mg solid X, Drug: JNJ 39393406 120 mg solid YThree participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks. 30 mg of solid X, 120 mg of solid Y, 30 mg of solid Y, and 120 mg of solid X. |
| Part 1; Period 2 | Experimental | Drug: JNJ 39393406 30 mg solid X, Drug: JNJ 39393406 30 mg solid Y, Drug: JNJ 39393406 120 mg solid X, Drug: JNJ 39393406 120 mg solid YThree participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks. 30 mg of solid Y, 30 mg of solid X, 120 mg of solid X and 120 mg of solid Y. |
| Part 1; Period 3 | Experimental | Drug: JNJ 39393406 30 mg solid X, Drug: JNJ 39393406 30 mg solid Y, Drug: JNJ 39393406 120 mg solid X, Drug: JNJ 39393406 120 mg solid YThree participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 120 mg of solid X, 30 mg of solid Y, 120 mg of solid Y, and 30 mg of solid X. |
| Part 1; Period 4 | Experimental | Drug: JNJ 39393406 30 mg solid X, Drug: JNJ 39393406 30 mg solid Y, Drug: JNJ 39393406 120 mg solid X, Drug: JNJ 39393406 120 mg solid YThree participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 120 mg of solid Y, 120 mg of solid X, 30 mg of solid X, and 30 mg of solid Y. |
| Part 2; Period 1 | Experimental | Drug: JNJ 39393406 30 mg solid X, Drug: JNJ 39393406 30 mg solid Y, Drug: JNJ 39393406 120 mg solid X, Drug: JNJ 39393406 120 mg solid Y, Drug: JNJ 39393406 30 mg solutionFour participants will receive 30 mg of JNJ 39393406 of 2 different formulations (solid formulation selected from Part 1 and solution) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 30 mg of solid formulation, and 30 mg of solution. |
| Part 2; Period 2 | Experimental | Drug: JNJ 39393406 30 mg solid X, Drug: JNJ 39393406 30 mg solid Y, Drug: JNJ 39393406 120 mg solid X, Drug: JNJ 39393406 120 mg solid Y, Drug: JNJ 39393406 30 mg solutionFour participants will receive 30 mg of JNJ 39393406 of 2 different formulations (solid formulation selected from Part 1 and solution) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 30 mg of solution, and 30 mg of solid formulation. |
| Part 3 | Experimental | Drug: JNJ 39393406 30 mg solid X, Drug: JNJ 39393406 30 mg solid YEight participants (same participants from Part 2) will receive JNJ 39393406 (dose will likely be 30 mg, or another multiple of the 30 mg solid dose form selected in Part 1, but not higher than 210 mg) from Days 1 to 7. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male participants
- Body mass index (BMI) between 18 and 30 kg/m2 (BMI is calculated as weight [kilogram] divided by square of height [meter])
- Willing to adhere to the prohibitions and restrictions specified in the protocol
- Must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Key exclusion criteria (5 listed)
- Clinically significant abnormal values for clinical chemistry, hematology or urinalysis at screening or admission
- Clinically significant abnormal physical examination, neurological examination, vital signs or 12 lead electrocardiogram at screening
- Significant history of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, bronchospastic respiratory disease, dyspnea, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, infection, or any other illness that the investigator considers clinically significant
- Significant history of or current psychiatric or neurological illness
- Serology positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus antibodies at screening
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 |
|---|---|---|
| JNJ 39393406 30 mg solid XParticipants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth). | Drug | Part 1; Period 1, Part 1; Period 2, Part 1; Period 3, Part 1; Period 4, Part 2; Period 1, Part 2; Period 2, Part 3 |
| JNJ 39393406 30 mg solid YParticipants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth). | Drug | Part 1; Period 1, Part 1; Period 2, Part 1; Period 3, Part 1; Period 4, Part 2; Period 1, Part 2; Period 2, Part 3 |
| JNJ 39393406 120 mg solid XParticipants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth). | Drug | Part 1; Period 1, Part 1; Period 2, Part 1; Period 3, Part 1; Period 4, Part 2; Period 1, Part 2; Period 2 |
| JNJ 39393406 120 mg solid YParticipants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth). | Drug | Part 1; Period 1, Part 1; Period 2, Part 1; Period 3, Part 1; Period 4, Part 2; Period 1, Part 2; Period 2 |
| JNJ 39393406 30 mg solutionParticipants will receive JNJ 39393406 30 mg/mL solution orally (by mouth). | Drug | Part 2; Period 1, Part 2; Period 2 |
Primary outcome
Maximum plasma concentration of JNJ 39393406
Time frame: Predose to 96 hrs postdose (Part 1 and Part 2 [after each single-dose administration]); predose to 24 hrs postdose (Day 1); predose to 5 hrs postdose (Days 3 and 5); predose to 96 hrs (Day 8), and end of study (7 to 14 days after the last dose) (Part 3)
Maximum plasma concentration of JNJ 39393406, determined by visual inspection of the data
Time to reach the maximum plasma concentration of JNJ 39393406
Time frame: Predose to 96 hrs postdose (Part 1 and Part 2 [after each single-dose administration]); predose to 24 hrs postdose (Day 1); predose to 5 hrs postdose (Days 3 and 5); predose to 96 hrs (Day 8), and end of study (7 to 14 days after the last dose) (Part 3)
Time to reach the maximum plasma concentration, determined by visual inspection of the data
Area under the plasma concentration-time curve of JNJ-39393406
Time frame: Predose to 96 hrs postdose (Part 1 and Part 2 [after each single-dose administration]); predose to 24 hrs postdose (Day 1); predose to 5 hrs postdose (Days 3 and 5); predose to 96 hrs (Day 8), and end of study (7 to 14 days after the last dose) (Part 3
Number of participants with adverse events
Time frame: Up to 7 to 14 days after last dose of study medication (Part 1, Part 2, and Part 3)
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 18 Nov 2013.
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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 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 JNJ 39393406 30 mg solid X, JNJ 39393406 30 mg solid Y and JNJ 39393406 120 mg solid X 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 4 inclusion and 5 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 18 Nov 2013. 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?
Maximum plasma concentration of JNJ 39393406 (time frame: Predose to 96 hrs postdose (Part 1 and Part 2 [after each single-dose administration]); predose to 24 hrs postdose (Day 1); predose to 5 hrs postdose (Days 3 and 5); predose to 96 hrs (Day 8), and end of study (7 to 14 days after the last dose) (Part 3)). The study lists 4 primary outcomes in all. 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 18 Nov 2013.