JNJ-40929837 is being developed for the treatment of asthma. MedDRA version: 12.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: JNJ-40929837-AEO - Tablet - 50 mg
Product Code: JNJ-40929837
Pharmaceutical Form: Tablet
INN or Proposed INN: N/A
CAS Number: 1191044-47-9
Current Sponsor code: JNJ-40929837
Concentratio
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Potential subjects must satisfy all of the following criteria to be enrolled in the study: 1.Are between 18 and 55 years of age, inclusive 2.With the exception of atopic disease (such as allergic rhinitis and atopic dermatitis), are healthy on the basis of: a.physical examination, medical history, vital signs, and 12 lead ECG performed at screening b.clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the subject's source documents and initialed by the investigator 3.Have mild atopic asthma requiring no other treatment besides occasional short acting beta2 agonists (see exclusion criterion 76.d.) 4.Have an FEV1 at Screening Visit 1 at least 75% of the predicted value 5.Have a history of asthma symptoms during exposure to indoor or outdoor allergens and a positive skin prick test done at the study site to Der p1, mixed grass pollen, or cat dander 6.Have allergen induced early asthmatic response (EAR) of at least a 20% reduction in FEV1 and late asthmatic response (LAR) of at least a 15% reduction in FEV1 during bronchial allergen challenge (BAC) performed at screening 7.Women must Be one of the following prior to entry: a)postmenopausal (not experiencing a menstrual period for a minimum of two years), confirmed by a documented serum follicle stimulating hormone (FSH) level >40 IU/L b)surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), supported with clinical documentation c)abstinent (at the discretion of the investigator/per local regulations) d)be practicing a highly effective method of birth control, if sexually active, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (eg, condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel), or male partner sterilization, consistent with local regulations regarding use of birth control methods for subjects participating in clinical trials, for the duration of their participation in the study. Note: hormonal contraceptives must have been used consistently for 3 months prior to screening 8.Male subjects must consent to utilize a medically acceptable method of contraception throughout the study and not donate sperm during the study. Medically acceptable methods of contraception that may be used by the subject and/or the partner include abstinence, diaphragm with vaginal spermicide, IUD, condom and partner using vaginal spermicide, surgical sterilization (6 months post surgery), post-menopausal partner (not experiencing a menstrual period for a minimum of two years) and hormonal contraceptives (which must be used consistently for 3 months prior to screening) such as oral contraceptives, hormonal patches, progestin implants or injections, and etonogestrel/ ethinyl estradiol vaginal rings (NuvaRing). 9.Female subjects must have a negative serum pregnancy test at screening 10.Have a negative alcohol test at screening 11.Be willing/able to adhere to the prohibitions and restrictions specified in this protocol 12.Have a negative urine drug test at screening 1
Exclusion criteria
Exclusion criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: 1.Have a significant medical condition aside from asthma and other atopic diseases (such as allergic rhinitis and atopic dermatitis) 2.Have a recent myocardial infarction (450 msec (men) or >460 msec (women) at screening, a history of risk factors for torsades de pointe (eg, heart failure, hypokalemia, family history of Long QT Syndrome), or are currently using medications that prolong the QT/QTc interval or that inhibit P glycoprotein 11.Have used tobacco products of any kind currently or within the 6 months prior to screening or have a smoking history >10 pack years 12.Consumption of poppy seed containing foods within 3 days of screeningstudy visit 1 13.Have a positive anti HCV or evidence of HBV infection (positive HBsAg and/or HBcAb test) at screening 14.Have known allergies, hypersensitivity, or intolerance to JNJ 40929837, montelukast, or their excipients (refer to Section 14.1, Physical Description of Study Drug[s]) 15.Have received an investigational drug (including vaccines) or used an investigational medical device within 30 days before screening or are currently enrolled in an investigational study 16.Have donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months before the first administration of study drug or intention to donate blood or blood products during the study or within 90 days after the completion of the study 17.Are pregnant, nursing, or planning pregnancy within one year after screening 18.Have any condition that, in the opinion of the investigator, would compromise the well being of the subject or the study or prevent the subject from meeting or performing study requirements, including inability to understand the procedures and the implications of challenge testing 19.Are known to have a current substance abuse (drug, alcohol, or nicotine) problem 20.Have difficulty swallowing t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the allergen-induced late asthmatic response (LAR), as measured by maximal percent fall in FEV1, in subjects with stable mild atopic asthma after treatment with JNJ 40929837 compared to placebo.;Secondary Objective: •To compare the effects of JNJ 40929837 and placebo on allergen induced EAR, as measured by maximal percent fall in FEV1 •To compare the effects of JNJ 40929837 and placebo on allergen induced EAR and LAR, as measured by area under the FEV1/time curves •To evaluate the safety of JNJ 40929837 •To characterize the pharmacokinetic and pharmacodynamic relationship of JNJ 40929837 and sputum LTB4 (Sputum Substudy) ;Primary end point(s): •Maximal percent fall in FEV1 between 3 to 10 hours post allergen challenge from pre allergen challenge | — |
Countries
Germany, United Kingdom
Outcome results
None listed