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A Study of JNJ-40411813 in Healthy Japanese Male Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04677530
Recruitment Status : Completed
First Posted : December 21, 2020
Last Update Posted : June 9, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) after single dose and multiple dose administrations of JNJ-40411813 in Japanese healthy adult male participants.

Condition or disease Intervention/treatment Phase
Healthy Drug: JNJ-40411813 Drug: Matching Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: A Double-blind, Placebo-controlled, Randomized, Single Ascending Dose and Multiple Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-40411813 in Healthy Japanese Adult Male Subjects
Actual Study Start Date : January 29, 2021
Actual Primary Completion Date : May 21, 2021
Actual Study Completion Date : May 21, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: JNJ-40411813 or Matching Placebo
Participants will receive a single oral dose of JNJ-40411813 or a matching placebo in Cohorts 1, 2, and 3.
 Drug: JNJ-40411813
JNJ-40411813 will be administered orally.

Drug: Matching Placebo
Matching placebo will be administered orally.
Experimental: Part 2: JNJ-40411813
Participants will receive a single oral dose of JNJ-40411813 in Cohort 4.
 Drug: JNJ-40411813
JNJ-40411813 will be administered orally.
Experimental: Part 3: JNJ-40411813 or Matching Placebo
Participants will receive a multiple oral dose of JNJ-40411813 or a matching placebo in Cohort 5 and optional Cohort 6.
 Drug: JNJ-40411813
JNJ-40411813 will be administered orally.

Drug: Matching Placebo
Matching placebo will be administered orally.


Outcome Measures
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Primary Outcome Measures :
  1. Parts 1 and 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 6 weeks ]
    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

  2. Part 3: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 8 weeks ]
    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

  3. Parts 1 and 2: Plasma Concentration of JNJ-40411813 [ Time Frame: Predose, up to 96 hours postdose (Day 5) ]
    Plasma samples will be analyzed to determine concentrations of JNJ-40411813 using a validated, specific, and sensitive liquid chromatography mass spectrometry/mass spectrometry (LC-MS/MS).

  4. Part 3: Plasma Concentration of JNJ-40411813 [ Time Frame: Predose, up to 312 hours postdose (Day 14) ]
    Plasma samples will be analyzed to determine concentrations of JNJ-40411813 using a validated, specific, and sensitive LC-MS/MS.


Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  • Be a Japanese man
  • Be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, 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. This determination must be recorded in the participant's source documents and initialed by the investigator
  • Blood pressure (after the participant supine for 5 minutes) between 90 and 140 millimeter of Mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
  • During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study intervention, a participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person. Male participants should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak. Recommended highly effective methods of contraception in this study for female partners of male participants to use in addition to the male participant wearing a condom during include: a) oral hormonal contraception, b) intrauterine device, c) intrauterine hormone-releasing system, and d) bilateral tubal occlusion
  • A participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last dose of study intervention

Exclusion Criteria:

  • History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening as deemed appropriate by the investigator
  • Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) at screening as deemed appropriate by the investigator
  • Known allergies, hypersensitivity, or intolerance to JNJ-40411813 or its excipients
  • Test positive for human immunodeficiency virus (HIV) antigen/antibodies, hepatitis A antibody immunoglobulin M (IgM), syphilis, hepatitis B surface antigen (HbsAg) or hepatitis C virus (HCV) antibodies at screening
Contacts and Locations
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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): NCT04677530


Locations
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Japan
Souseikai Fukuoka Mirai Hospital
Fukuoka-shi, Japan, 813-0017
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
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Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.
More Information
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Additional Information:

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Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT04677530    
Other Study ID Numbers: CR108942
40411813EDI1011 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: June 9, 2021
Last Verified: June 2021
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/clinicaltrials/ 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: No
Studies a U.S. FDA-regulated Device Product: No