A Study to Assess the Relative Oral Bioavailability of JNJ-63623872 Administered as Oral Concept Formulations Compared to the Current Tablet Formulation

NCT02659735 | Completed Phase 1

• 3 other identifiers: CR10810963623872FLZ10062015-002299-26
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the rate and extent of absorption of JNJ-63623872 following administration of a single dose as three different concept formulations with that following administration of the current formulation, under both fed and fasted conditions, in healthy adult participants.

Conditions

Influenza A Virus

Keywords

Influenza A virus; JNJ-63623872; Healthy

Outcome Measures

Primary Outcomes (6)

• Maximum Observed Plasma Concentration (Cmax)

  The Cmax is the maximum observed plasma concentration.

  Day 1

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

  Day 1

• Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])

  The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.

  Day 1

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])

  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.

  Day 1

• Elimination Rate Constant (Lambda[z])

  Lambda(z) is first-order elimination 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.

  Day 1

• Elimination Half-Life (t1/2)

  The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).

  Day 1

Secondary Outcomes (3)

• Number of Participants With Adverse Events

  Baseline up to 10 to 14 days after last study drug administration

• Taste Questionnaire Assessment

  Day 1

• Swallowability Assessment

  Day 1

Study Arms (10)

Panel 1: Treatment ADBC

EXPERIMENTAL

Participants will receive Treatment A (600 milligram \[mg\] JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fed conditions) in Period 1; followed by Treatment D (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #3 \[test 3\] under fed conditions) in Period 2; followed by Treatment B (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1 \[test 1\] under fed conditions) in Period 3; followed by Treatment C (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #2 \[test 2\] under fed conditions) in Period 4. A washout period of 7 days will be maintained between each treatment period.

Drug: JNJ-63623872 300 milligram (mg); Drug: JNJ-63623872 600 mg

Panel 1: Treatment BACD

EXPERIMENTAL

Participants will receive Treatment B (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1 \[test 1\] under fed conditions) in Period 1; followed by Treatment A (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fed conditions) in Period 2; followed by Treatment C (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #2 \[test 2\] under fed conditions) in Period 3; followed by Treatment D (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #3 \[test 3\] under fed conditions) in Period 4. A washout period of 7 days will be maintained between each treatment period.

Drug: JNJ-63623872 300 milligram (mg); Drug: JNJ-63623872 600 mg

Panel I: Treatment CBDA

EXPERIMENTAL

Participants will receive Treatment C (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #2 \[test 2\] under fed conditions) in Period 1; followed by Treatment B (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1 \[test 1\] under fed conditions) in Period 2; followed by Treatment D (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #3 \[test 3\] under fed conditions) in Period 3; followed by Treatment A (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fed conditions) in Period 4. A washout period of 7 days will be maintained between each treatment period.

Drug: JNJ-63623872 300 milligram (mg); Drug: JNJ-63623872 600 mg

Panel I: Treatment DCAB

EXPERIMENTAL

Participants will receive Treatment D (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #3 \[test 3\] under fed conditions) in Period 1; followed by Treatment C (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #2 \[test 2\] under fed conditions) in Period 2; followed by Treatment A (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fed conditions) in Period 3; followed by Treatment B (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1 \[test 1\] under fed conditions) in Period 4. A washout period of 7 days will be maintained between each treatment period.

Drug: JNJ-63623872 300 milligram (mg); Drug: JNJ-63623872 600 mg

Panel 2: Treatment EFG

EXPERIMENTAL

Participants will receive Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fasted conditions) in Period 1; followed by Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 4\] under fasted conditions) in Period 2; followed by Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 5\] under fed conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period.

Drug: JNJ-63623872 300 milligram (mg); Drug: JNJ-63623872 600 mg

Panel 2: Treatment FGE

EXPERIMENTAL

Participants will receive Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 4\] under fasted conditions) in Period 1; followed by Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 5\] under fed conditions) in Period 2; followed by Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fasted conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period.

Drug: JNJ-63623872 300 milligram (mg); Drug: JNJ-63623872 600 mg

Panel 2: Treatment GEF

EXPERIMENTAL

Participants will receive Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 5\] under fed conditions) in Period 1; followed by Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fasted conditions) in Period 2; followed by Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 4\] under fasted conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period.

Drug: JNJ-63623872 300 milligram (mg); Drug: JNJ-63623872 600 mg

Panel 2: Treatment GFE

EXPERIMENTAL

Participants will receive Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 5\] under fed conditions) in Period 1; followed by Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 4\] under fasted conditions) in Period 2; followed by Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fasted conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period.

Drug: JNJ-63623872 300 milligram (mg); Drug: JNJ-63623872 600 mg

Panel 2: Treatment FEG

EXPERIMENTAL

Participants will receive Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 4\] under fasted conditions) in Period 1; followed by Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fasted conditions) in Period 2; followed by Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 5\] under fed conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period.

Drug: JNJ-63623872 300 milligram (mg); Drug: JNJ-63623872 600 mg

Panel 2: Treatment EGF

EXPERIMENTAL

Participants will receive Treatment E (600 mg JNJ-63623872 formulated as the 300 mg oral tablet \[reference\] under fasted conditions) in Period 1; followed by Treatment G (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 5\] under fed conditions) in Period 2; followed by Treatment F (600 mg JNJ-63623872 formulated as the 600 mg oral concept formulation #1, #2 or #3 \[test 4\] under fasted conditions) in Period 3. A washout period of 7 days will be maintained between each treatment period.

Drug: JNJ-63623872 300 milligram (mg); Drug: JNJ-63623872 600 mg

Interventions

JNJ-63623872 300 milligram (mg) DRUG

Participants will receive 600 milligram (mg) JNJ-63623872 formulated as the 300 mg oral tablet on Day 1.

Panel 1: Treatment ADBC; Panel 1: Treatment BACD; Panel 2: Treatment EFG; Panel 2: Treatment EGF; Panel 2: Treatment FEG; Panel 2: Treatment FGE; Panel 2: Treatment GEF; Panel 2: Treatment GFE; Panel I: Treatment CBDA; Panel I: Treatment DCAB

JNJ-63623872 600 mg DRUG

Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #1 on Day 1.

Panel 1: Treatment ADBC; Panel 1: Treatment BACD; Panel 2: Treatment EFG; Panel 2: Treatment EGF; Panel 2: Treatment FEG; Panel 2: Treatment FGE; Panel 2: Treatment GEF; Panel 2: Treatment GFE; Panel I: Treatment CBDA; Panel I: Treatment DCAB

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A female participants must be either: a) Not of childbearing potential: 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 (FSH) level \>40 international Unit/Liter (IU/L); OR b) Permanently sterilized (example, bilateral tubal occlusion \[which includes tubal ligation procedures as consistent with local regulations\], hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or otherwise incapable of becoming pregnant; OR c) If of childbearing potential and heterosexually active, be practicing an effective method of contraception before entry and agree to continue to use two effective methods of contraception throughout the study and for at least 90 days after receiving 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 on Day -1
• Participants must have a Body Mass Index (BMI) between 18.0 and 30.0 kilogram per meter\^2 (kg/m\^2) (extremes included)
• Participants must have a blood pressure (after the participant is supine for at least 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at Screening
• Participants must be non-smokers for at least 3 months prior to Screening

You may not qualify if:

• Participant has a history of 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 participant or that could interfere with the interpretation of the study results
• Participant with a past history of heart arrhythmias (extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
• Participant with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
• 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 has taken any disallowed therapies before the planned first intake of study drug

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Antwerp, Belgium

Location

MeSH Terms

Interventions

pimodivir

Study Officials

• Janssen Research & Development, LLC Clinical Trials

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: January 20, 2016
• Study Start: December 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

BE (1)