Clinical trial NCT03010059: A Study to Assess the Relative Bioavailability of JNJ64041575 Administered as 2 Different New Concept Formulations (Oral Suspension and Tablet) Compared to Their Respective Current Formulations, and to Assess the Effect of Food on the Pharmacokinetics of the 2 New Concept Formulations
Official title: An Open-label, Randomized, 3-way Crossover Study in Healthy Adult Subjects to Assess the Relative Bioavailability of a Single Dose of JNJ-64041575 Administered as 2 Different New Concept Formulations (Oral Suspension and Tablet) Compared to Their Respective Current Formulations, and to Assess the Effect of Food on the Pharmacokinetics of the 2 New Concept Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-01-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the rate and extent of absorption of JNJ-64041575 by measuring ALS-008112 plasma concentrations following administration of a single oral dose of JNJ-64041575 given as 2 new concept formulations (oral suspension and tablet) compared to their respective current formulations under fasted conditions and to assess the effect of food on the pharmacokinetics of the 2 new concept formulations under fed condition in healthy adult participants.


Eligibility criteria: Inclusion Criteria:

* Participant must have a body mass index (BMI; weight in kg divided by the square of height in meters) between 18.0 and 30.0 kilogram per square meter kg/m\^2, extremes included, and a body weight not less than 50.0 kg, extremes included
* Participant must have a normal 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function at screening, including: a) normal sinus rhythm (heart rate between 45 and 100 beats per minute \[bpm\], extremes included); b) QT corrected according to Fridericia's formula (QTcF) interval less than or equal to (\<=)430 milliseconds (ms) for male participants and \<=450 ms for female participants; c) QRS interval \<=110 ms; d) PR interval \<=200 ms; e) ECG morphology consistent with healthy cardiac conduction and function. Any evidence of heart block, or of left or right bundle branch block is exclusionary
* Participants must have normal values for alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (less than or equal (\<=)1.0×upper limit of laboratory normal range \[ULN\])
* Contraceptive use by female participants should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies. Before randomization, a woman must be either: a) Not of childbearing potential defined as: 1) Postmenopausal: A postmenopausal state is defined as greater than (\>)45 years and no menses for 12 consecutive months without an alternative medical cause and a serum follicle stimulating hormone (FSH) level in the postmenopausal range (\>40 International units per liter \[IU/L\] or milli-international units per milliliter \[mIU/mL\]), OR; 2) Permanently sterile: Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures (without reversal operation), and bilateral oophorectomy b) Of childbearing potential and, if heterosexually active, 1) Practicing a highly effective method of contraception (failure rate of less than (\<)1percent (%) per year when used consistently and correctly) 2) Agrees to remain on a highly effective method throughout the study and for at least 44 days after the last dose of study drug
* A female participant, except if postmenopausal, must have a negative serum beta human chorionic gonadotropin (beta- hCG) pregnancy test at screening, and a negative urine pregnancy test on Day 1 in each treatment period
* Participant must be able to taste and smell normally, to their own opinion. Participants who have an impaired sense of taste and/or smell due to any conditions such as allergic rhinitis, common cold, or sinusitis are not eligible to take part in the study

Exclusion Criteria:

* Participant has a mouth pathology including, but not limited to, pain, ulcer, edema, mucosal erosion, gingivitis and/or (dental) abscesses, or receives treatment for oral pathologies (eg, antifungals or antibiotics) or oral treatment for any disease
* Participant with a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs
* Participant is hepatitis B surface antigen (HBsAg) positive or hepatitis C virus (HCV) antibody positive with HCV RNA positive, or has another clinically active liver disease at screening
* Participant has a history of human immunodeficiency virus type 1 (HIV-1) or HIV 2 antibody positive, or tests positive for HIV-1 or -2 at screening
* Participant has previously been dosed with JNJ-64041575 in more than 3 single-dose studies with JNJ-64041575 or has previously been dosed with JNJ-64041575 in a multiple-dose study with JNJ-64041575
* Participants with 1 or more of the following laboratory abnormalities at screening as defined by the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table a) Serum creatinine grade 1 or greater (greater \[\>\]1.0\* upper limit of laboratory normal range \[ULN\]) b) Hemoglobin grade 1 or greater (\<=10.5 gram per decilitre \[g/dL\]) c) Platelet count grade 1 or greater (\<=99.999/millimeter \[mm\]\^3) d) Reticulocyte count (absolute) below the lower limit of laboratory normal range (LLN) e) Absolute neutrophil count grade 1 or greater (\<=1,500/mm\^3) f) Total bilirubin grade 1 or greater (\>1.0\*ULN) g) Any other toxicity grade 2 or above, except for grade 2 elevations of low density lipoprotein (LDL) cholesterol and/or cholesterol

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of ALS-008112 (JNJ-63549109)
timeFrame: Up to Day 8
measure: Area Under Plasma Concentration Curve from time zero to the last quantifiable (AUC [0-last]) of ALS-008112 (JNJ-63549109)
timeFrame: Up to Day 8
measure: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ALS-008112 (JNJ-63549109)
timeFrame: Up to Day 8
Secondary outcomes:
measure: Time to Reach Maximum Concentration (Tmax) ALS-008112 (JNJ-63549109)
timeFrame: Up to Day 8
measure: Apparent Terminal Elimination Rate Constant (lambda z) of ALS-008112 (JNJ-63549109)
timeFrame: Up to Day 8
measure: Apparent Terminal Elimination Half-life (t1/2term) of ALS-008112 (JNJ-63549109)
timeFrame: Up to Day 8
measure: Maximum Observed Plasma Concentration (Cmax) of ALS-008144 (JNJ-64167896)
timeFrame: Up to Day 8
measure: Time to Reach Maximum Concentration (Tmax) of ALS-008144 (JNJ-64167896)
timeFrame: Up to Day 8
measure: Area Under Plasma Concentration Curve from time zero to the last quantifiable (AUC [0-last]) of ALS-008144 (JNJ-64167896)
timeFrame: Up to Day 8
measure: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ALS-008144 (JNJ-64167896)
timeFrame: Up to Day 8
measure: Apparent Terminal Elimination Rate Constant (lambda z) of ALS-008144 (JNJ-64167896)
timeFrame: Up to Day 8
measure: Apparent Terminal Elimination Half-life (t1/2term) of ALS-008144 (JNJ-64167896)
timeFrame: Up to Day 8
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Screening (28 days ) to Follow up Phase (10 to 14 days after last dose)
measure: Taste of JNJ-64041575 following administration of different oral suspension formulations under fed and fasted conditions in healthy adult participants in Panel 1 (taste questionnaire)
timeFrame: Day 1
measure: Taste and Swallowability of JNJ-64041575 following administration of different oral tablet formulations under fed and fasted conditions in healthy adult participants in Panel 2 (taste and swallowability questionnaire)
timeFrame: Day 1
Other outcomes:
Locations:
city: Merksem
country: Belgium
facility: Clinical Pharmacology Unit
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: