A Phase 1 interventional study of Formulation 2 and Formulation 1 in Healthy, sponsored by Janssen Research & Development, LLC. Completed at 1 site in Belgium. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-26.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the relative bioavailability (the extent to which a drug or other substance becomes available to the body) of JNJ-54781532 formulation 2 (test) compared with JNJ-54781532 formulation 1 (reference) in healthy participants under fed conditions at a single dose of 150 milligram (mg).
This is a randomized (study medication assigned to participants by chance), open-label (all people know the identity of the intervention), 2-treatment, 2-period, 2-sequence crossover (participants may receive different interventions sequentially during the trial), and single-center study of JNJ-54781532. The duration of study will be approximately of 5 weeks per participant. The study consists of 3 parts: Screening (that is, 21 days before study commences on Day 1); Open-label Treatment (consists of 2 single-dose treatments, either JNJ-54781532 formulation 1 [reference] or JNJ-54781532 formulation 2 [test]), in subsequent 2-treatment periods, each separated with washout period of 7 days); and End-of-Study (done upon completion of the 72-hour pharmacokinetic sampling on Day 4 of Period 2, or at the time of early withdrawal). All the eligible participants will be randomly assigned to 1 of the 2 treatment sequences to ensure that they receive both of the following treatments, one in each period. Followed by an overnight fast of at least 10 hours participants will be administered with study treatment 30 minutes after high-fat, high-calorie breakfast. Participants will not be allowed to have food until 4 hours of drug administration. Blood samples will be collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment. Relative bioavailability of two formulations of JNJ-54781532 (test and reference) will be evaluated primarily. Participants' safety will be monitored throughout the study.
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Exclusion Criteria:
Single-dose of JNJ-54781532 formulation 2 will be administered as 150 milligram (mg) oral tablet in first treatment period; followed by JNJ-54781532 formulation 1 as 150 mg orally (5\*30 mg tablet=150 mg) in second treatment period. A washout period of at least 7 days will be maintained between each treatment period.
Drug: Formulation 2 · Drug: Formulation 1
Single-dose of JNJ-54781532 formulation 1 will be administered as 150 mg oral tablet (5\*30 mg tablet=150 mg) in first treatment period; followed by JNJ-54781532 formulation 2 as 150 mg oral tablet in second treatment period. A washout period of at least 7 days will be maintained between each treatment period.
Drug: Formulation 2 · Drug: Formulation 1
Single-dose of JNJ-54781532 formulation 2 will be administered as 150 milligram (mg) oral tablet in one of the treatment periods.
Also known as: JNJ-54781532 Test
Single-dose of JNJ-54781532 formulation 1 will be administered as 150 milligram (mg) oral tablet (5\*30 mg tablet=150 mg) in one of the treatment periods.
Also known as: JNJ-54781532 Reference
Maximum Plasma Concentration (Cmax) of JNJ-54781532
The Cmax is the maximum observed plasma concentration.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1
Time to Reach Maximum Concentration (tmax) of JNJ-54781532
The tmax is time to reach the maximum observed plasma concentration.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of JNJ-54781532
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-54781532
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1
Relative Bioavailability of JNJ-54781532
Bioavailability means the extent to which the active ingredient of a drug dosage form becomes available at the site of drug action or in a biological medium believed to reflect accessibility to a site of action. Relative bioavailability of single-dose of two formulations of JNJ-54781532 will be compared in healthy participants under fed conditions.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1
Time to last quantifiable plasma concentration (tlast) of JNJ-54781532
The tlast is the time to last observed quantifiable plasma concentration.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1
Area Under the Plasma Concentration Percentage (%) Extrapolation of JNJ-54781532
The percentage of AUC (0-infinity) that is due to extrapolation from Tlast to infinity (AUC%Extrapolation) is calculated by using the formula AUC_%extrapolation = 100\*(AUC \[0-infinity\] minus (AUC \[0-last\])/(AUC (0-infinity).
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1
Elimination Half-Life (t [1/2] Lambda) of JNJ-54781532
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).
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1
Rate Constant (Lambda[z])
Lambda(z) is first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1
Adjusted Coefficient of Determination (R^2 adj)
The coefficient of determination adjusted for the number of points used in the estimation of Lambda(z).
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1
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