HealthyPhase 1NCT01932320
A Study to Evaluate the Relative Bioavailability, Food Effect and Effect of Ketoconazole on the Rate and Extent of Absorption of Solid Dosage Formulation(s) of JNJ-40411813
A Phase 1 study testing JNJ-40411813: Formulation A, JNJ-40411813: Formulation B and JNJ-40411813: Formulation C 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 compare the rate and extent of absorption of a single dose of two solid dose formulations relative to a nanosuspension formulation of JNJ-40411813 (Part 1); to evaluate the effect of a high-fat/high-calorie breakfast on the rate and extent of absorption of the selected JNJ-40411813… 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-40411813: Formulation A, JNJ-40411813: Formulation B and JNJ-40411813: Formulation C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2010to May 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
- Body mass index (BMI) between 18 and 30 kg/m2 (BMI is calculated as weight [kilogram] divided by square of height [meter])
- Non-smoker (not smoked for 3 months prior to screening)
Who cannot join
- Clinically significant abnormal values for laboratory tests and abnormal physical examination
- History of or current significant unstable medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection
- History of epilepsy or fits or unexplained black-outs and significant history of or current psychiatric or neurological illness
- Serology positive for hepatitis B surface antigen, hepatitis C antibodies or HIV antibodies at screening
- Positive urine screen for drugs of abuse and positive alcohol breath test at screening or start of study medication
- Clinically significant acute illness within 7 days prior to start of study medication
- Use of any prescription medication or over-the-counter medication (not including paracetamol), or herbal medication within 2 weeks of start of study medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Study to Investigate the Relative Bioavailability, Food Effect and Effect of Ketoconazole on the Rate and Extent of Absorption of Solid Dosage Formulation(s) of JNJ-40411813
The purpose of this study is to compare the rate and extent of absorption of a single dose of two solid dose formulations relative to a nanosuspension formulation of JNJ-40411813 (Part 1); to evaluate the effect of a high-fat/high-calorie breakfast on the rate and extent of absorption of the selected JNJ-40411813 solid dose formulation from Part 1 (Part 2); and to explore the influence of a potent inhibitor of CYP3A4, ketoconazole, on the rate and extent of absorption of the selected JNJ-40411813 solid dose formulation from Part 1 (Part 3).
Read the detailed description
This is an open-label (both physician and participants know the identity of the intervention) and single centre study. This study will be conducted in 3 parts (Part 1, Part 2, and Part 3). The study consists of 3 phases including, the screening phase (within 21 days prior to the start of study medication), treatment phase (Part 1: 20 days; Part 2: 12 days; Part 3: 16 days), and the follow-up phase (Part 1 and Part 2: approximately 14 days after the last administration of study medication and Part 3: 14 days after the last administration of ketaconazole). Approximately 36 participants will be enrolled in the study (12 participants in each part). Part 1 is randomized (study medication is assigned by chance) and 3-way cross-over (method used to switch participants from one treatment arm to another in a clinical study) part of the study. Participants in Part 1 will be randomly assigned to 1 of 3 treatment sequences (Period 1, Period 2, and Period 3) to receive single dose of 3 formulations of JNJ-40411813 (Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation) without food. Each period will be separated by a wash out period (no treatment) of at least 1 week. Part 2 is randomized and 2-way cross-over part of the study. Participants in Part 2 will be randomly assigned 1 of 2 treatment sequences (Period 1 and Period 2) to receive single dose of the selected solid dose formulation of JNJ-40411813 from Part 1 without food and with food separated by a wash out period of at least 1 week. Part 3 is single-arm sequential (carried out in a staged approach) part of the study. Participants in Part 3 will receive single dose of the selected solid dose formulation of JNJ-40411813 from Part 1 on two occasions (Day 1 and Day 10) without food along with ketoconazole from Day 6 to Day 14 with food. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, 12-lead electrocardiogram, and clinical laboratory tests which will be monitored throughout the study. The total duration of study participation for a participant will be 8 weeks.
- Conditions
- Healthy
- Being tested
- JNJ-40411813: Formulation A, JNJ-40411813: Formulation B, JNJ-40411813: Formulation C, Ketoconazole
- Keywords
- Healthy, Relative Bioavailability, Food effect, JNJ-40411813, Positive allosteric modulator, Solid Dosage Formulation of JNJ-40411813, Ketoconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-40411813: Formulation ADrug
Participants will receive JNJ-40411813 100 mg hard gelatin capsule orally (by mouth) as a single dose for Part 1 (Period 1, Period 2, and Period 3). If selected this formulation from Part 1, participants will receive this formulation at the dose of 50 mg to 150 mg orally without food and with food in Part 2 (Period 1, Period 2); and at the dose of 50 mg to 150 mg orally without food on Day 1 and Day 10 in Part 3.
JNJ-40411813: Formulation BDrug
Participants will receive JNJ-40411813 100 mg immediate release tablet orally as a single dose for Part 1 (Period 1, Period 2, and Period 3). If selected this formulation from Part 1, participants will receive this formulation at the dose of 50 mg to 150 mg orally without food and with food in Part 2 (Period 1, Period 2); and at the dose of 50 mg to 150 mg orally without food on Day 1 and Day 10 in Part 3.
JNJ-40411813: Formulation CDrug
Participants will receive JNJ-40411813 100 mg nanosuspension orally as a single dose for Part 1 (Period 1, Period 2, and Period 3).
KetoconazoleDrug
Participants will receive ketoconazole 200 mg tablet orally twice daily with food from Day 6 to Day 14 in Part 3.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Participants will receive single dose of all the 3 formulations of JNJ-40411813 (Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet, and Formulation C: Nanosuspension formulation) without food in 3 periods (Period 1, Period 2, and Period 3). The sequences will be based on a computer-generated randomization schedule prepared by the sponsor before the study. Each period will be separated by a wash out period (no treatment) of at least 1 week. Receives: Drug: JNJ-40411813: Formulation A; Drug: JNJ-40411813: Formulation B; Drug: JNJ-40411813: Formulation C |
| Part 2 | Experimental | Participants will receive single dose of the selected solid dose formulation of JNJ-40411813 (Formulation A or Formulation B) from Part 1 without food and with food in 2 periods (Period 1 and Period 2). The sequences will be based on a computer generated randomization schedule prepared by the sponsor before the study. Each period will be separated by a wash out period of at least 1 week. Receives: Drug: JNJ-40411813: Formulation A; Drug: JNJ-40411813: Formulation B |
| Part 3 | Experimental | Participants will receive single dose of the selected solid dose formulation of JNJ-40411813 (Formulation A or Formulation B) from Part 1 on two occasions (Day 1 and Day 10) without food along with ketoconazole from Day 6 to Day 14 with food. Receives: Drug: JNJ-40411813: Formulation A; Drug: JNJ-40411813: Formulation B; Drug: Ketoconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration of JNJ-40411813
This pharmacokinetics parameter will be analyzed for 3 formulations of JNJ-40411813: Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation.
Measured: 1 hour predose to 96 hours postdose (for Part 1 and Part 2 [after each single-dose administration]) and 1 hour predose to 120 hours postdose (for Part 3 [after each single-dose administration])
Time to reach the peak plasma concentration of JNJ-40411813
This pharmacokinetics parameter will be analyzed for 3 formulations of JNJ-40411813: Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation.
Measured: 1 hour predose to 96 hours postdose (for Part 1 and Part 2 [after each single-dose administration]) and 1 hour predose to 120 hours postdose (for Part 3 [after each single-dose administration])
Area under the plasma concentration of JNJ-40411813-time curve from 0 to t hours post dosing
This pharmacokinetics parameter will be analyzed for 3 formulations of JNJ-40411813: Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation.
Measured: 1 hour predose to 96 hours postdose (for Part 1 and Part 2 [after each single-dose administration]) and 1 hour predose to 120 hours postdose (for Part 3 [after each single-dose administration])
Area under the plasma concentration of JNJ-40411813 time curve from 0 to infinity post dosing
This pharmacokinetics parameter will be analyzed for 3 formulations of JNJ-40411813: Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation.
Measured: 1 hour predose to 96 hours postdose (for Part 1 and Part 2 [after each single-dose administration]) and 1 hour predose to 120 hours postdose (for Part 3 [after each single-dose administration])
Elimination rate constant of JNJ-40411813
This pharmacokinetics parameter will be analyzed for 3 formulations of JNJ-40411813: Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation.
Measured: 1 hour predose to 96 hours postdose (for Part 1 and Part 2 [after each single-dose administration]) and 1 hour predose to 120 hours postdose (for Part 3 [after each single-dose administration])
Terminal half-life of JNJ-40411813
This pharmacokinetics parameter will be analyzed for 3 formulations of JNJ-40411813: Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation.
Measured: 1 hour predose to 96 hours postdose (for Part 1 and Part 2 [after each single-dose administration]) and 1 hour predose to 120 hours postdose (for Part 3 [after each single-dose administration])
Relative bioavailability of JNJ-40411813
This pharmacokinetics parameter will be analyzed for 3 formulations of JNJ-40411813: Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation.
Measured: 1 hour predose to 96 hours postdose (for Part 1 and Part 2 [after each single-dose administration]) and 1 hour predose to 120 hours postdose (for Part 3 [after each single-dose administration])
Cumulative amount of JNJ-40411813 excreted in urine
This pharmacokinetics parameter will be analyzed for solid formulation of JNJ-40411813.
Measured: 1 hour predose to 120 hours postdose (for Part 3 [after each single-dose administration])
Renal clearance of JNJ-40411813
This pharmacokinetics parameter will be analyzed for solid formulation of JNJ-40411813.
Measured: 1 hour predose to 120 hours postdose (for Part 3 [after each single-dose administration])
Fraction of JNJ-40411813 excreted in urine until time 't'
This pharmacokinetics parameter will be analyzed for solid formulation of JNJ-40411813.
Measured: 1 hour predose to 120 hours postdose (for Part 3 [after each single-dose administration])
Secondary outcomes (1)
Number of participants with adverse events
Measured: Up to 8 weeks (for 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 posted30 Aug 2013 (estimated)
- Study startFeb 2010
- Primary completionMay 2010
- Study completionMay 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT01932320
- Sponsor's protocol ID
- CR016765
- Other IDs
- 40411813EDI1004, 2009-016638-28, 2009
- Status last verified
- Sep 2013
- First submitted
- 27 Aug 2013
- Last updated
- 9 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Investigate the Relative Bioavailability, Food Effect and Effect of Ketoconazole on the Rate and Extent of Absorption of Solid Dosage Formulation(s) of JNJ-40411813
- ClinicalTrials.gov ID
- NCT01932320
- Acronym / sponsor ID
- CR016765
- Conditions
- Healthy
- Keywords
- Healthy, Relative Bioavailability, Food effect, JNJ-40411813, Positive allosteric modulator, Solid Dosage Formulation of JNJ-40411813, Ketoconazole
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 30 Aug 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 this study is to compare the rate and extent of absorption of a single dose of two solid dose formulations relative to a nanosuspension formulation of JNJ-40411813 (Part 1); to evaluate the effect of a high-fat/high-calorie breakfast on the rate and extent of absorption of the selected JNJ-40411813 solid dose formulation from Part 1 (Part 2); and to explore the influence of a potent inhibitor of CYP3A4, ketoconazole, on the rate and extent of absorption of the selected JNJ-40411813 solid dose formulation from Part 1 (Part 3).
Detailed description
This is an open-label (both physician and participants know the identity of the intervention) and single centre study. This study will be conducted in 3 parts (Part 1, Part 2, and Part 3). The study consists of 3 phases including, the screening phase (within 21 days prior to the start of study medication), treatment phase (Part 1: 20 days; Part 2: 12 days; Part 3: 16 days), and the follow-up phase (Part 1 and Part 2: approximately 14 days after the last administration of study medication and Part 3: 14 days after the last administration of ketaconazole). Approximately 36 participants will be enrolled in the study (12 participants in each part). Part 1 is randomized (study medication is assigned by chance) and 3-way cross-over (method used to switch participants from one treatment arm to another in a clinical study) part of the study. Participants in Part 1 will be randomly assigned to 1 of 3 treatment sequences (Period 1, Period 2, and Period 3) to receive single dose of 3 formulations of JNJ-40411813 (Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation) without food. Each period will be separated by a wash out period (no treatment) of at least 1 week. Part 2 is randomized and 2-way cross-over part of the study. Participants in Part 2 will be randomly assigned 1 of 2 treatment sequences (Period 1 and Period 2) to receive single dose of the selected solid dose formulation of JNJ-40411813 from Part 1 without food and with food separated by a wash out period of at least 1 week. Part 3 is single-arm sequential (carried out in a staged approach) part of the study. Participants in Part 3 will receive single dose of the selected solid dose formulation of JNJ-40411813 from Part 1 on two occasions (Day 1 and Day 10) without food along with ketoconazole from Day 6 to Day 14 with food. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, 12-lead electrocardiogram, and clinical laboratory tests which will be monitored throughout the study. The total duration of study participation for a participant will be 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: JNJ-40411813: Formulation A, Drug: JNJ-40411813: Formulation B, Drug: JNJ-40411813: Formulation CParticipants will receive single dose of all the 3 formulations of JNJ-40411813 (Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet, and Formulation C: Nanosuspension formulation) without food in 3 periods (Period 1, Period 2, and Period 3). The sequences will be based on a computer-generated randomization schedule prepared by the sponsor before the study. Each period will be separated by a wash out period (no treatment) of at least 1 week. |
| Part 2 | Experimental | Drug: JNJ-40411813: Formulation A, Drug: JNJ-40411813: Formulation BParticipants will receive single dose of the selected solid dose formulation of JNJ-40411813 (Formulation A or Formulation B) from Part 1 without food and with food in 2 periods (Period 1 and Period 2). The sequences will be based on a computer generated randomization schedule prepared by the sponsor before the study. Each period will be separated by a wash out period of at least 1 week. |
| Part 3 | Experimental | Drug: JNJ-40411813: Formulation A, Drug: JNJ-40411813: Formulation B, Drug: KetoconazoleParticipants will receive single dose of the selected solid dose formulation of JNJ-40411813 (Formulation A or Formulation B) from Part 1 on two occasions (Day 1 and Day 10) without food along with ketoconazole from Day 6 to Day 14 with food. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
- Body mass index (BMI) between 18 and 30 kg/m2 (BMI is calculated as weight [kilogram] divided by square of height [meter])
- Non-smoker (not smoked for 3 months prior to screening)
Key exclusion criteria (7 listed)
- Clinically significant abnormal values for laboratory tests and abnormal physical examination
- History of or current significant unstable medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection
- History of epilepsy or fits or unexplained black-outs and significant history of or current psychiatric or neurological illness
- Serology positive for hepatitis B surface antigen, hepatitis C antibodies or HIV antibodies at screening
- Positive urine screen for drugs of abuse and positive alcohol breath test at screening or start of study medication
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-40411813: Formulation AParticipants will receive JNJ-40411813 100 mg hard gelatin capsule orally (by mouth) as a single dose for Part 1 (Period 1, Period 2, and Period 3). If selected this formulation from Part 1, participants will receive this formulation at the dose of 50 mg to 150 mg orally without food and with food in Part 2 (Period 1, Period 2); and at the dose of 50 mg to 150 mg orally without food on Day 1 and Day 10 in Part 3. | Drug | Part 1, Part 2, Part 3 |
| JNJ-40411813: Formulation BParticipants will receive JNJ-40411813 100 mg immediate release tablet orally as a single dose for Part 1 (Period 1, Period 2, and Period 3). If selected this formulation from Part 1, participants will receive this formulation at the dose of 50 mg to 150 mg orally without food and with food in Part 2 (Period 1, Period 2); and at the dose of 50 mg to 150 mg orally without food on Day 1 and Day 10 in Part 3. | Drug | Part 1, Part 2, Part 3 |
| JNJ-40411813: Formulation CParticipants will receive JNJ-40411813 100 mg nanosuspension orally as a single dose for Part 1 (Period 1, Period 2, and Period 3). | Drug | Part 1 |
| KetoconazoleParticipants will receive ketoconazole 200 mg tablet orally twice daily with food from Day 6 to Day 14 in Part 3. | Drug | Part 3 |
Primary outcome
Peak plasma concentration of JNJ-40411813
Time frame: 1 hour predose to 96 hours postdose (for Part 1 and Part 2 [after each single-dose administration]) and 1 hour predose to 120 hours postdose (for Part 3 [after each single-dose administration])
This pharmacokinetics parameter will be analyzed for 3 formulations of JNJ-40411813: Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation.
Time to reach the peak plasma concentration of JNJ-40411813
Time frame: 1 hour predose to 96 hours postdose (for Part 1 and Part 2 [after each single-dose administration]) and 1 hour predose to 120 hours postdose (for Part 3 [after each single-dose administration])
This pharmacokinetics parameter will be analyzed for 3 formulations of JNJ-40411813: Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation.
Area under the plasma concentration of JNJ-40411813-time curve from 0 to t hours post dosing
Time frame: 1 hour predose to 96 hours postdose (for Part 1 and Part 2 [after each single-dose administration]) and 1 hour predose to 120 hours postdose (for Part 3 [after each single-dose administration])
This pharmacokinetics parameter will be analyzed for 3 formulations of JNJ-40411813: Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation.
Area under the plasma concentration of JNJ-40411813 time curve from 0 to infinity post dosing
Time frame: 1 hour predose to 96 hours postdose (for Part 1 and Part 2 [after each single-dose administration]) and 1 hour predose to 120 hours postdose (for Part 3 [after each single-dose administration])
This pharmacokinetics parameter will be analyzed for 3 formulations of JNJ-40411813: Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation.
Elimination rate constant of JNJ-40411813
Time frame: 1 hour predose to 96 hours postdose (for Part 1 and Part 2 [after each single-dose administration]) and 1 hour predose to 120 hours postdose (for Part 3 [after each single-dose administration])
This pharmacokinetics parameter will be analyzed for 3 formulations of JNJ-40411813: Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation.
Terminal half-life of JNJ-40411813
Time frame: 1 hour predose to 96 hours postdose (for Part 1 and Part 2 [after each single-dose administration]) and 1 hour predose to 120 hours postdose (for Part 3 [after each single-dose administration])
This pharmacokinetics parameter will be analyzed for 3 formulations of JNJ-40411813: Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation.
Relative bioavailability of JNJ-40411813
Time frame: 1 hour predose to 96 hours postdose (for Part 1 and Part 2 [after each single-dose administration]) and 1 hour predose to 120 hours postdose (for Part 3 [after each single-dose administration])
This pharmacokinetics parameter will be analyzed for 3 formulations of JNJ-40411813: Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation.
Cumulative amount of JNJ-40411813 excreted in urine
Time frame: 1 hour predose to 120 hours postdose (for Part 3 [after each single-dose administration])
This pharmacokinetics parameter will be analyzed for solid formulation of JNJ-40411813.
Renal clearance of JNJ-40411813
Time frame: 1 hour predose to 120 hours postdose (for Part 3 [after each single-dose administration])
This pharmacokinetics parameter will be analyzed for solid formulation of JNJ-40411813.
Fraction of JNJ-40411813 excreted in urine until time 't'
Time frame: 1 hour predose to 120 hours postdose (for Part 3 [after each single-dose administration])
This pharmacokinetics parameter will be analyzed for solid formulation of JNJ-40411813.
1 secondary outcome
Number of participants with adverse events
Time frame: Up to 8 weeks (for 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 9 Sep 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-40411813: Formulation A, JNJ-40411813: Formulation B and JNJ-40411813: Formulation C 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 3 inclusion and 7 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 9 Sep 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?
Peak plasma concentration of JNJ-40411813 (time frame: 1 hour predose to 96 hours postdose (for Part 1 and Part 2 [after each single-dose administration]) and 1 hour predose to 120 hours postdose (for Part 3 [after each single-dose administration])). The study lists 10 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 9 Sep 2013.