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| Sponsor: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT01054352 |
Purpose
A single and multiple dose study to assess the safety of JNJ 38224342 compared to placebo in healthy volunteers and in volunteers with seasonal allergies.
| Condition | Intervention | Phase |
|---|---|---|
|
Seasonal Allergic Rhinitis |
Drug: JNJ38224342/placebo Drug: JNJ38224342 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Food Effect, and Pharmacokinetics and Pharmacodynamics of JNJ-38224342 in Healthy Patients and in Healthy Patients With Seasonal Allergic Rhinitis |
| Enrollment: | 182 |
| Study Start Date: | February 2010 |
| Study Completion Date: | March 2011 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 001
JNJ38224342/placebo one of six (6) single ascending doses (25 100 300 600 1250 or 2000 mg) of JNJ 38224342 or matching placebo up to four (4) additional cohorts consisting of healthy male volunteers may be added
|
Drug: JNJ38224342/placebo
one of six (6) single ascending doses (25, 100, 300, 600, 1250 or 2000 mg) of JNJ 38224342 or matching placebo
|
|
Experimental: 002
JNJ38224342/placebo multiple ascending oral doses (100 250 500 750 mg) of JNJ 38224342 or matching placebo administered for 14 consecutive days in healthy male or female volunteers.up to four (4) additional cohorts consisting of healthy male or female volunteers may be added
|
Drug: JNJ38224342/placebo
up to four (4) additional cohorts consisting of healthy male volunteers may be added
|
|
Experimental: 003
JNJ38224342 single oral 100mg dose of JNJ 38224342 as a solution versus a single oral dose of JNJ 38224342 as a capsule formulation with and without food in healthy male volunteers
|
Drug: JNJ38224342
multiple ascending oral doses (100, 250, 500, 750 mg) of JNJ 38224342 or matching placebo, administered for 14 consecutive days in healthy male or female volunteers
|
|
Experimental: 004
JNJ38224342/placebo multiple oral doses of JNJ38224342 or matching placebo administered for up to 14 consecutive days in male and female volunteers number of days dosed and actual dose levels food requirements and regimens will be determined based on the data from Parts 1 2 and 3.
|
Drug: JNJ38224342/placebo
.up to four (4) additional cohorts consisting of healthy male or female volunteers may be added
|
A four-part, single and multiple dose study to investigate the safety of JNJ-38224342 versus placebo in healthy patients and in patients with seasonal allergies. Volunteers (or patients) are randomly assigned to one of four treatment groups or Parts. Part 1 and 2 are randomized (study drug will be assigned by chance) and double-blind (neither the physician nor volunteer knows the identity of the assigned drug). In Part 1 patients receive a single oral dose of either 25, 100, 300, 600, 1250 or 2000 mg of JNJ-38224342 or placebo. In Part 2 patients receive multiple oral doses of either 100, 250, 500 or 700 mg of JNJ-38224342 or placebo administered over 14 days. Part 3 (for male volunteers only) is 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-38224342. Participants will be given a single 100 mg oral dose (either solution or capsule formulation). Part 4 is for patients with seasonal allergies only. The dose of JNJ-38224342 will be determined based on information collected in Parts 1 - 3. Patients that participate in part 4 of the study will also have their nasal passage flushed out with salt water and the contents will be collected. Patients will be asked to remain in the clinic for either 5 days or 18 days depending on what part of the study they are participating in. A physical exam will be performed and a medical history collected. Safety evaluations include adverse event monitoring, blood pressure measurements, ECG and lab work requiring blood and urine samples at various time points throughout the study. Single oral dose of either 25, 100, 300, 600, 1250 or 2000mg of JNJ-38224342 or placebo; Multiple oral dose of either 100, 250, 500 or 700 mg of JNJ-38224342 or placebo administered over 14 days; single oral 100mg dose of JNJ 38224342 as a solution versus capsule with or without food; multiple oral doses of JNJ38224342 or placebo administered for up to 14 days where the number of days dosed, actual dose levels, food requirements will be determined based on the data from Parts 1, 2, and 3
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
| Responsible Party: | Sr. Director, Clinical Research, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT01054352 History of Changes |
| Other Study ID Numbers: | CR016798 |
| Study First Received: | January 21, 2010 |
| Last Updated: | May 19, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Seasonal allergies Allergic rhinitis |
|
Rhinitis, Allergic, Seasonal Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity |
Otorhinolaryngologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Respiratory Tract Infections |