Antwerp, Belgium
NCT Number: NCT02231489
Study to Assess the Relative Bioavailability of Orally Administered JNJ-42756493 Tablet Versus JNJ-42756493 Capsule in Healthy Participants
The purpose of this study is to evaluate the relative bioavailability of JNJ-42756493 oral dose of capsule (reference) versus tablet (test) in healthy participants.
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Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
About this study
This is a Phase 1, randomized (study drug assigned by chance), open-label (all people know the identity of the intervention), 2 way crossover (method used to switch participants from one study group change to treatment group), single-dose study in healthy participants. The study will consist of 3 phases: Screening Phase (Day -21 to Day -2), Treatment Phase (consists of 2 single-dose treatment period, either JNJ-42756493 capsule or JNJ-42756493 tablet) and Follow-up Phase (12-14 days after last dose). All the eligible participants will be randomly assigned to 1 of the 2 treatment sequences to ensure that they receive both of the treatments, 1 in each period. Each treatment regimen will be separated by a washout period of at least 15 days. Blood samples will be collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment. Relative bioavailability of two dosage form of JNJ-42756493 (test and reference) will be evaluated primarily. Participants' safety will be monitored throughout the study.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
JNJ-42756493 Tablet
DrugParticipants will receive 10 mg of JNJ-42756493 tablet as single oral dose on Day 1 of each treatment period.
JNJ-42756493 Capsule
DrugParticipants will receive 10 mg of JNJ-42756493 capsule as single oral dose on Day 1 of each treatment period.
JNJ-61818549
DrugParticipants will JNJ-61818549, 100 microgram (mcg) intravenous infusion over 5 minutes, after 2 hours of administration of JNJ-42756493 tablet/capsule on Day 1 Treatment Period 1.
Primary outcomes
-
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
The F (abs) is the percentage of the orally administered dose that is systemically available. It is calculated as (AUC [0-infinity] for test)/(AUC [0-infinity] for reference [ref])*(D for ref/D for test )*100, where the reference treatment is an intravenous administration, AUC (0-infinity) is area under the concentration-time curve from time zero to extrapolated infinite time, and D is the dose of orally administered drug.
-
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
The F (rel) is the percentage of the orally administered dose that is systemically available. It is calculated as (AUC [0-infinity] for test)/(AUC [0-infinity] for reference [ref])*(D for test/D for ref )*100, where the reference treatment is an intravenous administration, AUC (0-infinity) is area under the concentration-time curve from time zero to extrapolated infinite time, and D is the dose of orally administered drug.
Secondary outcomes
-
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
The Cmax is the maximum plasma concentration.
-
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
Time to reach the maximum plasma JNJ4-2756493 concentration.
-
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
Elimination half-life (t [1/2] Lambda) is associated with the terminal slope (lambda [z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
Sponsors and collaborators
Lead sponsor
Janssen Research & Development, LLC
Industry
Registry information
Official study 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
Important dates
- Study start
- 2014
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Sep 4, 2014
- Registry last updated
- Dec 3, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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