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
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Condition or disease | Intervention/treatment | Phase |
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Healthy | Drug: JNJ-73763989 Drug: Placebo | Phase 1 |
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 |
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Experimental: Panel A: JNJ-73763989 or Placebo
Participants will receive JNJ-73763989 (Dose Level 1) or matching placebo as single subcutaneous injection.
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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.
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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.
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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. |
- 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.
- 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.
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
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
United Kingdom | |
PAREXEL International | |
London, United Kingdom, HA1 3UJ |
Study Director: | Janssen Sciences Ireland UC Clinical Trial | Janssen Sciences Ireland UC |
Responsible Party: | Janssen Sciences Ireland UC |
ClinicalTrials.gov Identifier: | NCT04002752 |
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 |
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 |