A Study of JNJ-73763989 in Healthy Japanese Adult Participants

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04002752
• Other study ID #: CR108646
• Secondary ID: 2019-000629-3173
• Status: Completed
• Phase: Phase 1
• Start date: July 4, 2019
• Est. completion date: August 23, 2019

Study information

• Verified date: September 2019
• Source: Janssen Sciences Ireland UC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 23, 2019
• Est. primary completion date: August 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United Kingdom	PAREXEL International	London

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Sciences Ireland UC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989	Cmax is the maximum observed plasma analyte concentration.	Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989	Tmax is defined as actual sampling time to reach maximum observed plasma analyte concentration.	Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose
Primary	Last Measurable Observed Plasma Concentration (Clast) of JNJ-73763989	Clast is last measurable observed plasma analyte concentration.	Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose
Primary	Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Measurable Concentration (AUC[0-last]) of JNJ-73763989	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.	Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose
Primary	Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.	Up to 30 days after last study drug administration (Up to 7 weeks)

External Links

•   To learn how to participate in this trial please click here.