A Study to Assess the Relative Bioavailability of JNJ-42756493 Tablets

• Register: ClinicalTrials.gov
• Last refreshed on: 17 November 2015
• Main ID: NCT02466815
• Date of registration: 05/06/2015
• Prospective Registration: No
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study to Assess the Relative Bioavailability of JNJ-42756493 Tablets
• Scientific title: Open-Label, Randomized, 3-Way Crossover Design to Assess the Relative Bioavailability of JNJ-42756493 Tablets
• Date of first enrolment: June 2015
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02466815
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
• Phase: Phase 1

Countries of recruitment

Belgium

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants should be willing to adhere to the prohibitions and restrictions
specified in this protocol

- Woman must be either: postmenopausal (greater than (>) 45 years of age with
amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and
a serum follicle stimulating hormone (follicle stimulating hormone [FSH]) >40
international unit per litre [IU/L]); surgically sterile

- Woman must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy
test at screening and a negative urine pregnancy test on Day -1 of each treatment
period

- Woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted
reproduction during the study and for 3 months after receiving the last dose of study
drug.

- Man who is sexually active with a woman of childbearing potential and has not had a
vasectomy, must agree to use a highly effective method of contraception as deemed
appropriate by the investigator and to not donate sperm during the study and for 3
months after receiving the last dose of study drug

Exclusion Criteria:

- Participants with 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, hepatic or renal
insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any
other illness that the investigator considers should exclude the subject 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 clinically significant abnormal values for hematology, clinical
chemistry, or urinalysis at screening or at Day -1 of Period 1 as deemed appropriate
by the investigator

- Participants with clinically significant abnormal physical examination, vital signs,
or 12-lead electrocardiogram (ECG) at screening or at Day -1 of Period 1 as deemed
appropriate by the investigator

- Participants with 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 until
completion of the study



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

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: JNJ-42756493 Current Clinical Formulation (G-018)

Drug: JNJ-42756493 Prototype Formulation I (G-025)

Drug: JNJ-42756493 Prototype Formulation II (G-025)

Primary Outcome(s)

Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Observed Quantifiable Concentration (Clast) (AUC[0-last]) of JNJ-42756493 [Time Frame: Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7]

Maximum Observed Plasma Concentration (Cmax) of JNJ-42756493 [Time Frame: Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7]

Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[0-24]) of JNJ-42756493 [Time Frame: Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7]

Area Under the Plasma Concentration-time Curve From Time 0 to Infinite Time AUC (infinity) of JNJ-42756493 [Time Frame: Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7]

Secondary Outcome(s)

Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [Time Frame: Screening up to end of study (up to 3 months)]

Secondary ID(s)

2015-001583-19

42756493EDI1004

CR107460

Source(s) of Monetary Support

Please refer to primary and secondary sponsors