MedTrace Logo

Safety, Tolerability, Pharmacokinetic and Absolute Bioavailability Study of JNJ-63623872 Administered as an Intravenous Infusion and a 600-Milligram (mg) Oral Dose in Healthy Adults

NCT02860806 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2018-01-30

No results posted yet for this study

Summary

The purpose of this study is to characterize the single-dose pharmacokinetic (PK) of single escalating intravenous (IV) doses of JNJ-63623872 administered as a continuous infusion; to evaluate the safety and tolerability of single escalating IV doses of JNJ-63623872 administered as a continuous infusion; to characterize the single-dose PK of JNJ-63623872 of one selected dose administered as a continuous IV infusion at various durations and to characterize the single- and repeat-dose PK of JNJ-63623872 administered as a continuous infusion.

Conditions

  • Healthy

Interventions

DRUG

JNJ-63623872

3 mg/mL solution as intravenous (IV) infusion or a single oral 600 mg dose (2 tablets of 300 mg) under fasted conditions will be administered.

DRUG

Placebo

Intravenous infusion of matching placebo.

Sponsors & Collaborators

  • Janssen-Cilag International NV

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag International NV Clinical Trial · Janssen-Cilag International NV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-08
Primary Completion
2017-06-06
Completion
2017-06-10

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02860806 on ClinicalTrials.gov