A Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-63623872 in Healthy Japanese Adult Participants

NCT02418559 | Completed Phase 1

• 3 other identifiers: CR1067622015-000247-1663623872FLZ1008
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of JNJ-63623872 following oral administration of single ascending dose of JNJ-63623872 in healthy Japanese adult participants.

Conditions

Healthy

Keywords

Healthy; JNJ-63623872; Japanese Adult Participants

Outcome Measures

Primary Outcomes (10)

• Maximum Plasma Concentration (Cmax) of JNJ-63623872

  The Cmax is the maximum observed plasma concentration of JNJ-63623872.

  Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post-dose

• Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-63623872

  The Tmax is the time to reach the maximum observed plasma concentration of JNJ-63623872.

  Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post-dose

• Time of Last Measurable Plasma Concentration (Tlast) of JNJ-63623872

  Time of last measurable (non-below quantification limit \[non-BQL\]) plasma concentration.

  Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post-dose

• Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Observed Quantifiable Concentration (AUC [0-last]) of JNJ-63623872

  The AUC (0-last) is the area under the plasma JNJ-63623872 concentration-time curve from time 0 to time of the last observed (non-BQL) quantifiable concentration, calculated by linear-linear trapezoidal summation.

  Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post-dose

• Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of JNJ-63623872

  The AUC (0-infinity) is the area under the plasma JNJ-63623872 concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma JNJ-63623872 concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed (non-BQL) quantifiable concentration and lambda(z) is elimination rate constant. Extrapolations of more than 20.00% of the total AUC are reported as approximations.

  Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post-dose

• Percentage of Area Under the Plasma Concentration-Time Curve Obtained by Extrapolation (%AUC[infinity,ex])

  The %AUC\[infinity,ex\] is calculated by dividing the difference of AUC(0-infinity) and AUC(0-last) by AUC(0-infinity) and then multiplying by 100, (AUC\[0-infinity\] - AUC\[0-last\])\*100/AUC\[0-infinity\].

  Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post-dose

• Elimination Rate Constant (Lambda [z]) of JNJ-63623872

  The Lambda (z) determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.

  Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post-dose

• Apparent Terminal Half-life (t[1/2]) of JNJ-63623872

  The t(1/2) is defined as 0.693/Lambda (z).

  Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post-dose

• Total Apparent Clearance (CL/F) of JNJ-63623872

  The CL/F is defined as Dose/AUC (0-infinity).

  Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post-dose

• Apparent Volume of Distribution (Vd/F) of JNJ-63623872

  The Vd/F is defined as Dose/\[Lambda (z)\*AUC (0-infinity)\].

  Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post-dose

Secondary Outcomes (1)

• Number of Participants with Adverse Events (AEs) and Serious AEs

  Screening up to follow-up (7-10 days after dose administration)

Study Arms (3)

JNJ-63623872 (300 mg) or Placebo

EXPERIMENTAL

Participants will receive JNJ-63623872 300 milligram (mg) or placebo tablet orally once on Day 1 under fasted conditions.

Drug: JNJ-63623872 (300 mg); Drug: Placebo

JNJ-63623872 (600 mg) or Placebo

EXPERIMENTAL

Participants will receive JNJ-63623872 600 mg (2\*300 mg) or placebo tablet orally once on Day 1 under fasted conditions.

Drug: JNJ-63623872 (600 mg); Drug: Placebo

JNJ-63623872 (1200 mg) or Placebo

EXPERIMENTAL

Participants will receive JNJ-63623872 1200 mg (4\*300 mg) or placebo tablet orally once on Day 1 under fasted conditions.

Drug: JNJ-63623872 (1200 mg); Drug: Placebo

Interventions

JNJ-63623872 (300 mg) DRUG

Participants will receive JNJ-63623872 300 mg tablet orally once on Day 1 under fasted conditions.

JNJ-63623872 (300 mg) or Placebo

JNJ-63623872 (600 mg) DRUG

Participants will receive JNJ-63623872 600 mg (2\*300 mg) tablet orally once on Day 1 under fasted conditions.

JNJ-63623872 (600 mg) or Placebo

JNJ-63623872 (1200 mg) DRUG

Participants will receive JNJ-63623872 1200 mg (4\*300 mg) tablet orally once on Day 1 under fasted conditions.

JNJ-63623872 (1200 mg) or Placebo

Placebo DRUG

Participants will receive placebo tablet orally once on Day 1 under fasted conditions.

JNJ-63623872 (1200 mg) or Placebo; JNJ-63623872 (300 mg) or Placebo; JNJ-63623872 (600 mg) or Placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be a Japanese participant who has resided outside Japan for no more than 5 years and whose parents and grandparents are Japanese as determined by participant's verbal report
• Each participant must sign an Informed Consent Form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
• Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
• A female participant must be either:
• Not of childbearing potential: postmenopausal \[greater than (\>) 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level \>40 International Units (IU)/ liter (L) (to be confirmed at Screening for all postmonopausal women)\] OR
• Permanently sterilized (eg, 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, practicing an effective method of birth control before entry and agree to continue to use two effective methods of contraception throughout the study and for at least 30 days after receiving the study drug
• A male participant who is sexually active with a woman of childbearing potential must agree to use two effective methods of birth control for 30 days after receiving the study drug, and a male participant must also not donate sperm during the study and for 3 months after receiving the study drug

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 (eg, hypokalemia, family history of long QT Syndrome)
• Participants with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
• Participants 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 as noted in protocol, Pre-study and Concomitant Therapy before the planned study drug

Sponsors & Collaborators

• Janssen Infectious Diseases BVBA: lead

Study Sites (1)

Unknown Facility

Harrow, United Kingdom

Location

MeSH Terms

Interventions

pimodivir

Study Officials

• Janssen Infectious Diseases BVBA Clinical Trial

  Janssen Infectious Diseases BVBA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: April 16, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 22, 2015

Record last verified: 2015-09

Locations

GB (1)