A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery

Summary

The primary purpose of Part 1 in this study is to assess the safety and tolerability of JNJ-64179375 for each dose level for dose escalation and any bleeding events (the composite of major, clinically relevant non-major, and minimal bleeding events) for the selection of doses for Part 2. The primary purpose of Part 2 is to assess the efficacy dose response of JNJ-64179375 for the prevention of total venous thromboembolism (VTE) (proximal and/or distal deep vein thrombosis \[DVT\] \[asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic\], nonfatal pulmonary embolism \[PE\], or any death).

Conditions

• VTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery

Interventions

DRUG

JNJ-64179375 0.3 mg/kg

JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenous (IV) infusion as a single dose on Day 1.

DRUG

JNJ-64179375 0.6 mg/kg

JNJ-64179375 0.6 mg/kg IV infusion as a single dose on Day 1.

DRUG

JNJ-64179375 1.2 mg/kg

JNJ-64179375 1.2 mg/kg IV infusion as a single dose on Day 1.

DRUG

JNJ-64179375 (Dose to be Determined)

JNJ-64179375 IV infusion (Dose to be determined) as a single dose on Day 1.

DRUG

JNJ-64179375 A mg/kg

JNJ-64179375 Dose A mg/kg IV as a single dose on Day 1.

DRUG

JNJ-64179375 B mg/kg

JNJ-64179375 Dose B mg/kg IV as a single dose on Day 1.

DRUG

JNJ-64179375 C mg/kg

JNJ-64179375 Dose C mg/kg IV as a single dose on Day 1.

DRUG

JNJ-64179375 D mg/kg

JNJ-64179375 Dose D mg/kg IV as a single dose on Day 1.

DRUG

Placebo JNJ-64179375

Matching JNJ-64179375 placebo (normal saline) administered as IV infusion as a single dose on Day 1.

DRUG

Apixaban placebo

Matching apixaban placebo administered orally twice a day for 10 to 14 days.

DRUG

Apixaban 2.5 mg

Apixaban 2.5 mg administered orally twice a day for 10 to 14 days.

Sponsors & Collaborators

• Janssen Research & Development, LLC

  lead INDUSTRY

Principal Investigators

• Janssen Research Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-13

Primary Completion

2018-11-05

Completion

2018-11-05

FDA Drug

Yes

Countries

• United States
• Argentina
• Belgium
• Brazil
• Bulgaria
• Canada
• Italy
• Japan
• Latvia
• Lithuania
• Malaysia
• Poland
• Russia
• Spain
• Turkey (Türkiye)
• Ukraine

Study Locations