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Trial record 1 of 1 for:    NCT04002752
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A Study of JNJ-73763989 in Healthy Japanese Adult Participants

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ClinicalTrials.gov Identifier: NCT04002752
Recruitment Status : Completed
First Posted : July 1, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Sciences Ireland UC

Brief Summary:
The purpose of this study is to investigate the pharmacokinetics, safety, and tolerability of JNJ-73763989 in healthy Japanese adult participants following single-dose subcutaneous administration of 3 different doses of JNJ-73763989, Dose Level 1 (Panel A), Dose Level 2 (Panel B) or Dose Level 3 (Panel C).

Condition or disease Intervention/treatment Phase
Healthy Drug: JNJ-73763989 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: A Double-blind, Placebo-controlled, Randomized, Parallel, Single Dose Study to Investigate Pharmacokinetics, Safety, and Tolerability of JNJ-73763989 in Healthy Japanese Adult Participants
Actual Study Start Date : July 4, 2019
Actual Primary Completion Date : August 23, 2019
Actual Study Completion Date : August 23, 2019

Arm Intervention/treatment
Experimental: Panel A: JNJ-73763989 or Placebo
Participants will receive JNJ-73763989 (Dose Level 1) or matching placebo as single subcutaneous injection.
Drug: JNJ-73763989
Participants will receive JNJ-73763989 as single subcutaneous injection.

Drug: Placebo
Participants will receive placebo matching to JNJ-73763989 as single subcutaneous injection.

Experimental: Panel B: JNJ-73763989 or Placebo
Participants will receive JNJ-73763989 (Dose Level 2) or matching placebo as single subcutaneous injection.
Drug: JNJ-73763989
Participants will receive JNJ-73763989 as single subcutaneous injection.

Drug: Placebo
Participants will receive placebo matching to JNJ-73763989 as single subcutaneous injection.

Experimental: Panel C: JNJ-73763989 or Placebo
Participants will receive JNJ-73763989 (Dose Level 3) or matching placebo as single subcutaneous injection.
Drug: JNJ-73763989
Participants will receive JNJ-73763989 as single subcutaneous injection.

Drug: Placebo
Participants will receive placebo matching to JNJ-73763989 as single subcutaneous injection.




Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 [ Time Frame: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose ]
    Cmax is the maximum observed plasma analyte concentration.

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 [ Time Frame: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose ]
    Tmax is defined as actual sampling time to reach maximum observed plasma analyte concentration.

  3. Last Measurable Observed Plasma Concentration (Clast) of JNJ-73763989 [ Time Frame: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose ]
    Clast is last measurable observed plasma analyte concentration.

  4. Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Measurable Concentration (AUC[0-last]) of JNJ-73763989 [ Time Frame: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose ]
    AUC(0-last) is area under the plasma concentration-time curve from time zero to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.

  5. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 30 days after last study drug administration (Up to 7 weeks) ]
    AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.



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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant must be a Japanese participant who has resided outside Japan for no more than 10 years and whose parents and grandparents are Japanese, as determined by participant's verbal report
  • Participant must have a body mass index (BMI; weight in kilogram [kg] divided by the square of height in meters) of 18.0 to 30.0 kilogram per square meter (kg/m^2) extremes included, and body weight not less than 45.0 kg
  • Participant must be healthy on the basis of physical examination, clinical laboratory tests, medical history, and vital signs performed at screening. In case of abnormalities (except for those listed in the exclusion criteria) a participant may be included after all if the investigator judges the abnormalities not clinically significant or appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
  • A female participant of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test on Day -1
  • A male participant must agree not to donate sperm after enrollment (Day 1) in the study until at least 90 days after receiving the study drug

Exclusion Criteria:

  • Participant with a history of cardiac arrhythmias (for example, premature ventricular contractions), history of risk factors for Torsade de Pointes syndrome (for example, hypokalemia, family history of long QT Syndrome)
  • Female participant who is pregnant, breast-feeding, or planning to become pregnant during the study or within 90 days after receiving the study drug (or longer, if dictated by local regulation)
  • Male participants who plan to father a child during the study or within 90 days after receiving the study drug (or longer, if dictated by local regulation)
  • Participant with human immunodeficiency virus type 1 (HIV-1) or type 2 (HIV-2) infection (confirmed by antibodies) at screening
  • Participant with current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M [IgM]), or hepatitis B infection (confirmed by Hepatitis B surface antigen [HBsAg]), or hepatitis C virus (HCV) infection (confirmed by HCV antibody), or hepatitis E infection (confirmed by hepatitis E antibody IgM) at screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002752


Locations
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United Kingdom
PAREXEL International
London, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Janssen Sciences Ireland UC
Investigators
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Study Director: Janssen Sciences Ireland UC Clinical Trial Janssen Sciences Ireland UC

Additional Information:
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Responsible Party: Janssen Sciences Ireland UC
ClinicalTrials.gov Identifier: NCT04002752     History of Changes
Other Study ID Numbers: CR108646
2019-000629-31 ( EudraCT Number )
73763989HPB1001 ( Other Identifier: Janssen Sciences Ireland UC )
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes