Study to Assess the Relative Bioavailability of Orally Administered JNJ-42756493 Tablet Versus JNJ-42756493 Capsule in Healthy Participants

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02231489
• Date of registration: 01/09/2014
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: Study to Assess the Relative Bioavailability of Orally Administered JNJ-42756493 Tablet Versus JNJ-42756493 Capsule in Healthy Participants
• Scientific title: A Single-Dose, Open Label, Randomized, Two-Way Crossover Pharmacokinetic Study to Assess the Relative Bioavailability of Orally Administered JNJ-42756493 Following Intake of Tablet Versus Capsule in Healthy Subjects
• Date of first enrolment: September 2014
• Target sample size: 12
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02231489
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Belgium

Contacts

• Name: Janssen Research & Development, LLC Clinical Trials
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants who have received a thorough explanation of the optional pharmacogenomic
research component of the study and was offered an opportunity to participate by
signing the separate pharmacogenomic informed consent document

- Female participants must be postmenopausal (no spontaneous menses for at least 2
years, or surgically sterile and must have a negative serum beta human chorionic
gonadotropin (hCG) pregnancy test at screening

- Male participants must agree to use an adequate contraception method as deemed
appropriate by the investigator (for example, vasectomy, double-barrier, partner
using effective contraception) and to not donate sperm during the study and for 3
months after receiving the last dose of study drug

- Participant must have body mass index (BMI) (weight [kilogram {kg}]/height^2 [m^2])
between 18 and 30 kg/m^2 (inclusive), and body weight not less than 50 kg

- Participants must be non-smoker for at least 6 months before entering the study

Exclusion Criteria:

- Participants with a history of or current clinically significant medical illness
including (but not limited to) cardiac arrhythmias or other cardiac disease,
hematologic disease, coagulation disorders (including any abnormal bleeding or blood
dyscrasias), lipid abnormalities, significant pulmonary disease, including
bronchospastic respiratory disease, diabetes mellitus, renal or hepatic
insufficiency, thyroid disease, neurologic or psychiatric disease, metabolic bone
disease, infection, or any other illness that the investigator considers should
exclude the participant or that could interfere with the interpretation of the study
results

- Participants with history or current evidence of ophthalmic disorder, such as central
serous retinopathy or retinal vein occlusion, active wet age related macular
degeneration, diabetic retinopathy with macular edema, uncontrolled glaucoma, corneal
pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion,
inflammation or ulceration

- Participants with the use of any prescription or nonprescription medication
(including vitamins and herbal supplements), except for paracetamol and hormonal
replacement therapy within 14 days before the first dose of the study drug is
scheduled

- Participants with positive test for drugs of abuse, such as cannabinoids, alcohol,
opiates, cocaine, amphetamines, benzodiazepines, hallucinogens or barbiturates at
screening and on Day-1 of the first treatment period

- Participants with clinically significant abnormal values for hematology, clinical
chemistry or urinalysis at screening or at admission to the study center as deemed
appropriate by the investigator. Retesting of abnormal lab values that may lead to
exclusion will be allowed once



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: JNJ-42756493 Tablet

Drug: JNJ-61818549

Drug: JNJ-42756493 Capsule

Primary Outcome(s)

Absolute Bioavailability (F[abs]) of JNJ-42756493 [Time Frame: Pre-dose;15,30,60,120,130,140,150 and 165 minutes (min),3,4,6,8,12,24,32,48,72,96,120, 144 hours (hrs) post-dose on Day 1 in Treatment Period 1; pre-dose;, 0.25,0.5,1,2,3,4,6,8,12,24,32,48,72,96,120,144 post-dose on Day 1 in Treatment Period 2]

Relative Bioavailability (F[rel]) of JNJ-42756493 [Time Frame: Pre-dose;15,30,60,120,130,140,150 and 165 minutes (min),3,4,6,8,12,24,32,48,72,96,120, 144 hours (hrs) post-dose on Day 1 in Treatment Period 1; pre-dose;, 0.25,0.5,1,2,3,4,6,8,12,24,32,48,72,96,120,144 post-dose on Day 1 in Treatment Period 2]

Secondary Outcome(s)

Maximum Plasma Concentration (Cmax) of JNJ-42756493 [Time Frame: Pre-dose;15,30,60,120,130,140,150 and 165 minutes (min),3,4,6,8,12,24,32,48,72,96,120, 144 hours (hrs) post-dose on Day 1 in Treatment Period 1; pre-dose;, 0.25,0.5,1,2,3,4,6,8,12,24,32,48,72,96,120,144 post-dose on Day 1 in Treatment Period 2]

Time to Reach Maximum Concentration (tmax) [Time Frame: Pre-dose;15,30,60,120,130,140,150 and 165 minutes (min),3,4,6,8,12,24,32,48,72,96,120, 144 hours (hrs) post-dose on Day 1 in Treatment Period 1; pre-dose;, 0.25,0.5,1,2,3,4,6,8,12,24,32,48,72,96,120,144 post-dose on Day 1 in Treatment Period 2]

Elimination Half-Life (t [1/2] Lambda) [Time Frame: Pre-dose;15,30,60,120,130,140,150 and 165 minutes (min),3,4,6,8,12,24,32,48,72,96,120, 144 hours (hrs) post-dose on Day 1 in Treatment Period 1; pre-dose;, 0.25,0.5,1,2,3,4,6,8,12,24,32,48,72,96,120,144 post-dose on Day 1 in Treatment Period 2]

Secondary ID(s)

CR105269

2014-002635-33

42756493EDI1003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors