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Completed

NCT Number: NCT03346122

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy Participants

The purpose of this study is to evaluate safety and tolerability of JNJ-64991524 compared with placebo after administration of single ascending oral doses of JNJ-64991524 (Part 1) and multiple ascending oral doses of JNJ-64991524 (Part 2) in healthy participants.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg)

Antwerp, 2060, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Weigh at least 50 kilogram (kg), and have a body mass index (BMI) of 18 kg/ meter (m)^2 to 30 kg/m^2, inclusive, at screening
  • Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening and Day-1. This determination must be recorded in the participant's source documents and initialed by the investigator
  • Be otherwise healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the serum chemistry panel, including liver enzymes, white blood cell count and hematocrit, coagulation, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and confirmed initialed by the investigator
  • Have the platelet count pretreatment clinical laboratory values not below the normal range during Screening and Day -1
  • A woman must have a negative serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test on Day -2

Exclusion criteria

  • History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
  • Known allergies, hypersensitivity, or intolerance to JNJ-64991524 or its excipients
  • History of severe allergic reaction, angioedema, or anaphylaxis to drugs or food
  • Has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence
  • Has a history of or is infected with human immunodeficiency virus (HIV [positive serology for HIV antibody]); tests positive for hepatitis B virus (HBV) infection; has antibodies to hepatitis C virus (HCV) at screening

Treatment and study plan

JNJ-64991524 Dose Level 1

Drug

Participants will receive JNJ-64991524 at a Dose Level 1 in SAD Part 1 of study.

JNJ-64991524 Dose Level 2

Drug

Participants will receive JNJ-64991524 at a Dose Level 2 in SAD Part 1 of study.

JNJ-64991524 Dose Level 3

Drug

Participants will receive JNJ-64991524 at a Dose Level 3 in SAD Part 1 of study.

JNJ-64991524 Dose Level 4

Drug

Participants will receive JNJ-64991524 at a Dose Level 4 in SAD Part 1 of study.

JNJ-64991524 Dose Level 5

Drug

Participants will receive JNJ-64991524 at a dose of Dose Level 5 in SAD Part 1 of study.

JNJ-64991524 Dose Level 6

Drug

Participants will receive JNJ-64991524 at a Dose Level 6 in SAD Part 1 and MAD part 2 of study.

Placebo

Drug

Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.

JNJ-64991524 Dose Level 7

Drug

Participants will receive JNJ-64991524 at a dose of Dose Level 7 in MAD Part 2 of study for 14 days.

JNJ-64991524 Dose Level 8

Drug

Participants will receive JNJ-64991524 at a Dose Level 8 in MAD Part 2 of study for 14 days.

JNJ-64991524 Dose Level 9

Drug

Participants will receive JNJ-64991524 at a Dose Level 9 in MAD Part 2 of study for 14 days.

Primary outcomes

  1. Part 1: Single Ascending Dose (SAD): Number of Participants with Treatment Emergent Adverse Events (AEs) as a Measure of Safety and Tolerability

    Time frame: Up to Day 20

    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent were events between administration of study drug and up to Day 20 that were absent before treatment or that worsened relative to pre-treatment state.

  2. Part 2: Multiple Ascending Dose (MAD): Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability

    Time frame: Up to Day 28

    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent were events between administration of study drug and up to Day 28 that were absent before treatment or that worsened relative to pre-treatment state.

  3. Number of Participants with Abnormalities in Vital Signs, Physical Examinations, Electrocardiogram (ECG), Cardiac Telemetry and Clinically Significant Laboratory Findings

    Time frame: Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)

    Number of participants with abnormalities in vital signs, physical examinations, ECG, cardiac telemetry and clinically significant laboratory findings will be measured.

Secondary outcomes

  1. Plasma Concentration of JNJ-64991524

    Time frame: Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)

    Plasma concentration assessment will be done to characterize the pharmacokinetics (PK) of JNJ-64991524.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy Participants

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2017
Registry last updated
Jan 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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