A Study to Evaluate the Effect of JNJ-63623872 on Cardiac Repolarization Interval in Healthy Participants

NCT02658825 | Completed Phase 1

• 3 other identifiers: CR10810863623872FLZ10052015-004365-82
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of JNJ-63623872 on the QT/QTc interval at supratherapeutic exposure in healthy participants (Panel 2).

Conditions

Healthy

Keywords

Healthy; JNJ-63623872; Moxifloxacin

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Corrected QT Interval (QTc) at Different Time Points

  Electrocardiogram will be collected by Holter monitoring. The measured QT data will be corrected for heart rate using Fridericia (QTcF), Bazett (QTcB), and study-specific power (QTcP) correction methods. The QTcF as primary correction method.

  45, 30 and 15 minutes predose and 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours postdose on Day 1

Secondary Outcomes (9)

• Maximum Observed Concentration (Cmax)

  Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours post-dose on Day 1 of Treatment A of Dose Level 1, Treatment C of Dose Level 2 (Panel 1) and Treatment E (Panel 2)

• Time To Reach The Maximum Observed Concentration (Tmax)

  Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours post-dose on Day 1 of Treatment A of Dose Level 1, Treatment C of Dose Level 2 (Panel 1) and Treatment E (Panel 2)

• Observed Concentration at 24 Hours Post Dosing (C24h)

  Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours post-dose on Day 1 of Treatment A of Dose Level 1, and Treatment C of Dose Level 2 (Panel 1)

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

  Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours post-dose on Day 1 of Treatment A of Dose Level 1, and Treatment C of Dose Level 2 (Panel 1)

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

  Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 120 hours post-dose on Day 1 of Treatment A of Dose Level 1, and Treatment C of Dose Level 2 (Panel 1)

Study Arms (8)

Panel 1: Dose level 1

EXPERIMENTAL

Participants will receive either treatment A (JNJ-63623872, 2400 milligram (mg) tablet orally once on Day 1) or treatment B \[(placebo (matching with JNJ-63623872 2400 mg) tablet orally once on Day 1\].

Drug: JNJ-63623872 2400 milligram (mg); Drug: Placebo (Matching with JNJ-63623872 2400 mg)

Panel 1: Dose level 2

EXPERIMENTAL

Participants will receive either treatment C (JNJ-63623872, 3000 mg tablet orally once on Day 1) or treatment D \[placebo (matching with JNJ-63623872 3000 mg) tablet orally once on Day 1\].

Drug: JNJ-63623872 3000 mg; Drug: Placebo (Matching with JNJ-63623872 3000 mg)

Panel 2: Treatment EFG

EXPERIMENTAL

Participants will receive treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 1; followed by treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 2; followed by treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 3. A washout period of 5 days will be maintained between each treatment period.

Drug: JNJ-63623872; Drug: Moxifloxacin; Drug: Placebo (Matching with JNJ-63623872 Dose); Drug: Placebo (Matching with Moxifloxacin)

Panel 2: Treatment FGE

EXPERIMENTAL

Participants will receive treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 1; followed by treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 2; followed by treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 3. A washout period of 5 days will be maintained between each treatment period.

Drug: JNJ-63623872; Drug: Moxifloxacin; Drug: Placebo (Matching with JNJ-63623872 Dose); Drug: Placebo (Matching with Moxifloxacin)

Panel 2: Treatment GEF

EXPERIMENTAL

Participants will receive treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 1; followed by treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 2; followed by treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 3. A washout period of 5 days will be maintained between each treatment period.

Drug: JNJ-63623872; Drug: Moxifloxacin; Drug: Placebo (Matching with JNJ-63623872 Dose); Drug: Placebo (Matching with Moxifloxacin)

Panel 2: Treatment GFE

EXPERIMENTAL

Participants will receive treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 1; followed by treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 2; followed by treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 3. A washout period of 5 days will be maintained between each treatment period.

Drug: JNJ-63623872; Drug: Moxifloxacin; Drug: Placebo (Matching with JNJ-63623872 Dose); Drug: Placebo (Matching with Moxifloxacin)

Panel 2: Treatment FEG

EXPERIMENTAL

Participants will receive treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 1; followed by treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 2; followed by treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 3. A washout period of 5 days will be maintained between each treatment period.

Drug: JNJ-63623872; Drug: Moxifloxacin; Drug: Placebo (Matching with JNJ-63623872 Dose); Drug: Placebo (Matching with Moxifloxacin)

Panel 2: Treatment EGF

EXPERIMENTAL

Participants will receive treatment E (JNJ-63623872 dose selected in Panel 1 tablet and placebo matching with moxifloxacin) in Period 1; followed by treatment G (placebo matching with JNJ-63623872 and placebo matching with moxifloxacin) in Period 2; followed by treatment F (placebo matching with JNJ-63623872 and moxifloxacin 400 mg capsule) in Period 3. A washout period of 5 days will be maintained between each treatment period.

Drug: JNJ-63623872; Drug: Moxifloxacin; Drug: Placebo (Matching with JNJ-63623872 Dose); Drug: Placebo (Matching with Moxifloxacin)

Interventions

JNJ-63623872 2400 milligram (mg) DRUG

Participants will receive JNJ-63623872 2400 mg tablet orally once on Day 1 of Panel 1.

Panel 1: Dose level 1

JNJ-63623872 3000 mg DRUG

Participants will receive JNJ-63623872 3000 mg tablet orally once on Day 1 of Panel 1.

Panel 1: Dose level 2

JNJ-63623872 DRUG

Participants will receive JNJ-63623872 dose selected in Panel 1 tablet orally once on Day 1 of Panel 2.

Panel 2: Treatment EFG; Panel 2: Treatment EGF; Panel 2: Treatment FEG; Panel 2: Treatment FGE; Panel 2: Treatment GEF; Panel 2: Treatment GFE

Moxifloxacin DRUG

Participants will receive moxifloxacin 400 mg capsule orally once on Day 1 of Panel 2.

Panel 2: Treatment EFG; Panel 2: Treatment EGF; Panel 2: Treatment FEG; Panel 2: Treatment FGE; Panel 2: Treatment GEF; Panel 2: Treatment GFE

Placebo (Matching with JNJ-63623872 2400 mg) DRUG

Participants will receive placebo (matching with JNJ-63623872 2400 mg) tablet orally once on Day 1 of Panel 1.

Panel 1: Dose level 1

Placebo (Matching with JNJ-63623872 3000 mg) DRUG

Participants will receive placebo (matching with JNJ-63623872 3000 mg) tablet orally once on Day 1 of Panel 1 and 2.

Panel 1: Dose level 2

Placebo (Matching with JNJ-63623872 Dose) DRUG

Participants will receive placebo (matching with JNJ-63623872 dose) tablet orally once on Day 1 of Panel 2.

Panel 2: Treatment EFG; Panel 2: Treatment EGF; Panel 2: Treatment FEG; Panel 2: Treatment FGE; Panel 2: Treatment GEF; Panel 2: Treatment GFE

Placebo (Matching with Moxifloxacin) DRUG

Participants will receive placebo (matching with Moxifloxacin) tablet orally once on Day 1 of Panel 2.

Panel 2: Treatment EFG; Panel 2: Treatment EGF; Panel 2: Treatment FEG; Panel 2: Treatment FGE; Panel 2: Treatment GEF; Panel 2: Treatment GFE

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 is willing to participate in the study
• Participant must be willing and able to adhere to the prohibitions and restrictions specified in the protocol
• A female participant must agree not to donate eggs (ova, oocytes) during the study and for at least 90 days after receiving the (last dose of) study drug
• A male participant who is sexually active with a woman of childbearing potential must agree to use two effective methods of contraception during the study and for at least 90 days after receiving the (last dose of) study drug, and a male participant must also not donate sperm during the study and for at least 90 days after receiving the (last dose of) study drug
• Participants must be non-smokers for at least 3 months prior to Screening
• Participants must have a Body Mass Index (BMI) between 18.0 and 30.0 kilogram per meter\^2 (kg/m\^2) (inclusive) at 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
• Participants with a history of clinically relevant heart rhythm disturbances including atrial, junctional, re-entry, and ventricular tachycardias, and heart blocks
• Participants with unusual T wave morphology (such as bifid T wave) likely to interfere with QTc measurements
• Participants with electrolyte abnormalities (hypokalemia, hypocalcemia, hypomagnesemia) of grade 2 or above within 21 days prior to the (first) intake of the study drug
• Participants with a breast implant or a history of thoracic surgery likely to cause abnormality of the electrical conduction through thoracic tissues
• Participant has taken any disallowed therapies (Concomitant Therapy) before the planned (first) intake of study drug
• Participant has known allergies, hypersensitivity, or intolerance to JNJ-63623872, moxifloxacin or its excipients

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Antwerp, Belgium

Location

MeSH Terms

Interventions

pimodivir; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: January 20, 2016
• Study Start: January 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

BE (1)