HealthPhase 1NCT01054014
A Single and Multiple Dose Study to Explore the Safety Of JNJ-40346527 In Healthy Volunteers
A Phase 1 study testing JNJ-40346527 in people with Health, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in Belgium.
Trial summary
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and it is removed from the body over time) of single and multiple doses of JNJ-40346527 in 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
- Health
- What is being tested?
- JNJ-40346527
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2010to Jan 2011
- 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
- Must be generally in good health
- Have negative result for HIV,hepatitis B, and hepatitis C
- Non-smoker for at least 6 months
- Females must be of non childbearing potential,i.e., either: surgically sterile (bilateral tubal ligation or removal of ovaries and/or uterus or partial hysterectomy at least 6 months prior to dosing), or naturally postmenopausal for at least 2 years, with negative blood and urine pregnancy tests prior to dosing
- must consent to use a medically acceptable method of contraception throughout the entire study period and for 90 days after the study is completed
Who cannot join
- History of alcohol or drug abuse
- Average consumption of more than 5 cups of caffeinated beverages (tea/coffee/cocoa/cola) per day
- History of any type of significant allergies (eg, anaphylaxis, prominent respiratory and skin symptoms)
- Use of St.John's Wort (hypericin) for 30 days before first dosing
- Use of any type of hormone replacement therapy for 30 days before the first dose
- history of receiving a live virus vaccination within the past month or plans to receive vaccination with a live virus vaccine within 2 weeks following the last dose of medication
- receipt of an experimental drug or medical device within the last month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Food Effect, and Pharmacokinetics of JNJ-40346527 in Healthy Subjects
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and it is removed from the body over time) of single and multiple doses of JNJ-40346527 in healthy volunteers. This study will also investigate the pharmacokinetics of JNJ-40346527 with and without food.
Read the detailed description
JNJ-40346527 is an experimental drug that is being tested to see if it may be useful in treating of rheumatoid arthritis and other inflammatory diseases. This study will compare the effects (both good and bad) of JNJ-40346527 to those of placebo (which looks like the drug being studied but has no active ingredients) in healthy volunteers. This study will be the first study in which JNJ-40346527 is given to humans. This study is being conducted in three parts. Parts 1 and 2 are randomized (study drug will be assigned by chance), double-blind (neither the physician nor volunteer knows the identity of the assigned drug) studies comparing the safety and tolerability of JNJ-40346527 to placebo in 96 healthy volunteers. Part 3 is an open-label (all people involved know the identity of the assigned drug), 2-period crossover (meaning that volunteers will receive both treatments at different times) study of the effects of food on JNJ-40346527 in 8 healthy male volunteers. For Part 1, the participation period is a maximum of 64 days, including a screening visit, a 5-day in-clinic period and three follow-up visits. For Part 2, the participation period is a maximum of 83 days, including a screening visit, an 18-day in-clinic period and two follow-up visits. For Part 3, the participation period is a maximum of 59 days, including a screening visit, two 4-day in-clinic periods separated by a 7 day break, and a follow-up visit. For all three parts of the study, safety evaluations, which will include ECG (a cardiac function test), vital signs and monitoring of side-effects will be performed. Additionally, blood and urine samples will be collected for evaluation. Volunteers will participate in 1 of 3 parts; Part 1: volunteers will receive a single oral (by mouth) dose of JNJ-40346527 (10, 50, 150, 300, 600, or 1000mg) or placebo; Part 2: volunteers will receive oral doses of JNJ-40346527 (50, 150, 300, 500 or 750mg) or placebo once a day for 14 days; Part 3: volunteers will receive two oral doses of 150mg of JNJ-40346527 with and without food, with a 7-day break between doses.
- Conditions
- Health
- Being tested
- JNJ-40346527/Placebo, JNJ-40346527
- Keywords
- CR016795
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-40346527/PlaceboDrug
Single oral dose of JNJ-40346527 (either 10, 50, 150, 300, 600, or 1000mg) or Placebo
JNJ-40346527/PlaceboDrug
JNJ-40346527 once daily oral dose for 14 days (either 50, 150, 300, 500 or 750mg) or Placebo
JNJ-40346527Drug
JNJ-40346527 150mg one dose, either fasting (or with food), then after 7 days off treatment, JNJ-40346527 150mg either with food (or fasting)
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | JNJ-40346527/Placebo Single oral dose of JNJ-40346527 (either 10 50 150 300 600 or 1000mg) or Placebo Receives: Drug: JNJ-40346527/Placebo |
| 002 | Experimental | JNJ-40346527/Placebo JNJ-40346527 once daily oral dose for 14 days (either 50 150 300 500 or 750mg) or Placebo Receives: Drug: JNJ-40346527/Placebo |
| 003 | Experimental | JNJ-40346527 JNJ-40346527 150mg one dose either fasting (or with food) then after 7 days off treatment JNJ-40346527 150mg either with food (or fasting) Receives: Drug: JNJ-40346527 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety, tolerability and pharmacokinetics (PK) of JNJ-40346427 after administration of single and multiple oral ascending doses of JNJ-40346427 in healthy volunteers and the PK of JNJ-4034627 with and without food.
Measured: from time of dosing to follow-up (28-35 days)
Secondary outcomes (1)
To assess the pharmacodynamics (explores what the drug does to the body) of JNJ-40346527.
Measured: Part 1: Days 1 & 2; Part 2: Days 1, 7, 14, and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startJan 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 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
- NCT01054014
- Sponsor's protocol ID
- CR016795
- Status last verified
- Sep 2013
- First submitted
- 21 Jan 2010
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Food Effect, and Pharmacokinetics of JNJ-40346527 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01054014
- Acronym / sponsor ID
- CR016795
- Conditions
- Health
- Keywords
- CR016795
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Study completion
- Jan 2011 (actual)
- First posted
- 22 Jan 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 investigate the safety, tolerability and pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and it is removed from the body over time) of single and multiple doses of JNJ-40346527 in healthy volunteers. This study will also investigate the pharmacokinetics of JNJ-40346527 with and without food.
Detailed description
JNJ-40346527 is an experimental drug that is being tested to see if it may be useful in treating of rheumatoid arthritis and other inflammatory diseases. This study will compare the effects (both good and bad) of JNJ-40346527 to those of placebo (which looks like the drug being studied but has no active ingredients) in healthy volunteers. This study will be the first study in which JNJ-40346527 is given to humans. This study is being conducted in three parts. Parts 1 and 2 are randomized (study drug will be assigned by chance), double-blind (neither the physician nor volunteer knows the identity of the assigned drug) studies comparing the safety and tolerability of JNJ-40346527 to placebo in 96 healthy volunteers. Part 3 is an open-label (all people involved know the identity of the assigned drug), 2-period crossover (meaning that volunteers will receive both treatments at different times) study of the effects of food on JNJ-40346527 in 8 healthy male volunteers. For Part 1, the participation period is a maximum of 64 days, including a screening visit, a 5-day in-clinic period and three follow-up visits. For Part 2, the participation period is a maximum of 83 days, including a screening visit, an 18-day in-clinic period and two follow-up visits. For Part 3, the participation period is a maximum of 59 days, including a screening visit, two 4-day in-clinic periods separated by a 7 day break, and a follow-up visit. For all three parts of the study, safety evaluations, which will include ECG (a cardiac function test), vital signs and monitoring of side-effects will be performed. Additionally, blood and urine samples will be collected for evaluation. Volunteers will participate in 1 of 3 parts; Part 1: volunteers will receive a single oral (by mouth) dose of JNJ-40346527 (10, 50, 150, 300, 600, or 1000mg) or placebo; Part 2: volunteers will receive oral doses of JNJ-40346527 (50, 150, 300, 500 or 750mg) or placebo once a day for 14 days; Part 3: volunteers will receive two oral doses of 150mg of JNJ-40346527 with and without food, with a 7-day break between doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: JNJ-40346527/PlaceboJNJ-40346527/Placebo Single oral dose of JNJ-40346527 (either 10 50 150 300 600 or 1000mg) or Placebo |
| 002 | Experimental | Drug: JNJ-40346527/PlaceboJNJ-40346527/Placebo JNJ-40346527 once daily oral dose for 14 days (either 50 150 300 500 or 750mg) or Placebo |
| 003 | Experimental | Drug: JNJ-40346527JNJ-40346527 JNJ-40346527 150mg one dose either fasting (or with food) then after 7 days off treatment JNJ-40346527 150mg either with food (or fasting) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must be generally in good health
- Have negative result for HIV,hepatitis B, and hepatitis C
- Non-smoker for at least 6 months
- Females must be of non childbearing potential,i.e., either: surgically sterile (bilateral tubal ligation or removal of ovaries and/or uterus or partial hysterectomy at least 6 months prior to dosing), or naturally postmenopausal for at least 2 years, with negative blood and urine pregnancy tests prior to dosing
- must consent to use a medically acceptable method of contraception throughout the entire study period and for 90 days after the study is completed
Key exclusion criteria (7 listed)
- History of alcohol or drug abuse
- Average consumption of more than 5 cups of caffeinated beverages (tea/coffee/cocoa/cola) per day
- History of any type of significant allergies (eg, anaphylaxis, prominent respiratory and skin symptoms)
- Use of St.John's Wort (hypericin) for 30 days before first dosing
- Use of any type of hormone replacement therapy for 30 days before the first dose
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-40346527/PlaceboSingle oral dose of JNJ-40346527 (either 10, 50, 150, 300, 600, or 1000mg) or Placebo | Drug | 001 |
| JNJ-40346527/PlaceboJNJ-40346527 once daily oral dose for 14 days (either 50, 150, 300, 500 or 750mg) or Placebo | Drug | 002 |
| JNJ-40346527JNJ-40346527 150mg one dose, either fasting (or with food), then after 7 days off treatment, JNJ-40346527 150mg either with food (or fasting) | Drug | 003 |
Primary outcome
To assess the safety, tolerability and pharmacokinetics (PK) of JNJ-40346427 after administration of single and multiple oral ascending doses of JNJ-40346427 in healthy volunteers and the PK of JNJ-4034627 with and without food.
Time frame: from time of dosing to follow-up (28-35 days)
1 secondary outcome
To assess the pharmacodynamics (explores what the drug does to the body) of JNJ-40346527.
Time frame: Part 1: Days 1 & 2; Part 2: Days 1, 7, 14, and 15
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 4 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, 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 JNJ-40346527 in people with Health, 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 5 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 4 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?
To assess the safety, tolerability and pharmacokinetics (PK) of JNJ-40346427 after administration of single and multiple oral ascending doses of JNJ-40346427 in healthy volunteers and the PK of JNJ-4034627 with and without food. (time frame: from time of dosing to follow-up (28-35 days)). 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 4 Sep 2013.