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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03010059
• Date of registration: 03/01/2017
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: 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
• Scientific 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
• Date of first enrolment: February 6, 2017
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03010059
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (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:

- 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



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

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: JNJ-64041575 (oral suspension formulation)

Drug: JNJ-64041575 (oral tablet formulation )

Primary Outcome(s)

Area Under Plasma Concentration Curve from time zero to the last quantifiable (AUC [0-last]) of ALS-008112 (JNJ-63549109) [Time Frame: Up to Day 8]

Maximum Observed Plasma Concentration (Cmax) of ALS-008112 (JNJ-63549109) [Time Frame: Up to Day 8]

Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ALS-008112 (JNJ-63549109) [Time Frame: Up to Day 8]

Secondary Outcome(s)

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) [Time Frame: Day 1]

Area Under Plasma Concentration Curve from time zero to the last quantifiable (AUC [0-last]) of ALS-008144 (JNJ-64167896) [Time Frame: Up to Day 8]

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) [Time Frame: Day 1]

Number of Participants With Adverse Events as a Measure of Safety and Tolerability [Time Frame: Screening (28 days ) to Follow up Phase (10 to 14 days after last dose)]

Apparent Terminal Elimination Half-life (t1/2term) of ALS-008112 (JNJ-63549109) [Time Frame: Up to Day 8]

Apparent Terminal Elimination Half-life (t1/2term) of ALS-008144 (JNJ-64167896) [Time Frame: Up to Day 8]

Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ALS-008144 (JNJ-64167896) [Time Frame: Up to Day 8]

Apparent Terminal Elimination Rate Constant (lambda z) of ALS-008144 (JNJ-64167896) [Time Frame: Up to Day 8]

Time to Reach Maximum Concentration (Tmax) ALS-008112 (JNJ-63549109) [Time Frame: Up to Day 8]

Apparent Terminal Elimination Rate Constant (lambda z) of ALS-008112 (JNJ-63549109) [Time Frame: Up to Day 8]

Maximum Observed Plasma Concentration (Cmax) of ALS-008144 (JNJ-64167896) [Time Frame: Up to Day 8]

Time to Reach Maximum Concentration (Tmax) of ALS-008144 (JNJ-64167896) [Time Frame: Up to Day 8]

Secondary ID(s)

CR108251

64041575RSV1005

2016-004018-86

Source(s) of Monetary Support

Please refer to primary and secondary sponsors