A Study to Evaluate the Bioavailability, Safety and Tolerability of a Solid Dosage Formulation Relative to a Suspension of JNJ-54175446 in Healthy Male and Female Participants
NCT ID: NCT02930694
Last Updated: 2017-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2016-10-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Group 1: Treatment Sequence AB
Participants will receive Treatment A \[JNJ-54175446, 50 milligram (mg) capsule\] on Day 1 of period 1 followed by Treatment B \[JNJ-54175446, 50 mg suspension\] on Day 1 of period 2. Both the treatment periods will be separated by washout period of minimum 10 days.
JNJ-54175446 (capsule)
Participants will receive JNJ-54175446 capsule at a dose of 50 mg or 100 mg, orally.
JNJ-54175446 (suspension)
Participants will receive JNJ-54175446 suspension at a dose of 50 mg or 100 mg, orally.
Group 1: Treatment Sequence BA
Participants will receive Treatment B on Day 1 of period 1 followed by Treatment A on Day 1 of period 2. Both the treatment periods will be separated by washout period of minimum 10 days.
JNJ-54175446 (capsule)
Participants will receive JNJ-54175446 capsule at a dose of 50 mg or 100 mg, orally.
JNJ-54175446 (suspension)
Participants will receive JNJ-54175446 suspension at a dose of 50 mg or 100 mg, orally.
Group 2: Treatment Sequence CD
Participants will receive Treatment C \[JNJ-54175446, 100 mg capsule\] on Day 1 of period 1 followed by Treatment D \[JNJ-54175446, 100 mg suspension\] on Day 1 of period 2. Both the treatment periods will be separated by washout period of minimum 10 days.
JNJ-54175446 (capsule)
Participants will receive JNJ-54175446 capsule at a dose of 50 mg or 100 mg, orally.
JNJ-54175446 (suspension)
Participants will receive JNJ-54175446 suspension at a dose of 50 mg or 100 mg, orally.
Group 2: Treatment Sequence DC
Participants will receive Treatment D on Day 1 of period 1 followed by Treatment C on Day 1 of period 2. Both the treatment periods will be separated by washout period of minimum 10 days.
JNJ-54175446 (capsule)
Participants will receive JNJ-54175446 capsule at a dose of 50 mg or 100 mg, orally.
JNJ-54175446 (suspension)
Participants will receive JNJ-54175446 suspension at a dose of 50 mg or 100 mg, orally.
Interventions
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JNJ-54175446 (capsule)
Participants will receive JNJ-54175446 capsule at a dose of 50 mg or 100 mg, orally.
JNJ-54175446 (suspension)
Participants will receive JNJ-54175446 suspension at a dose of 50 mg or 100 mg, orally.
Eligibility Criteria
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Inclusion Criteria
* Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) \[inclusive QTcF less than or equal to (\<=) 450 millisecond (msec) for males and \<= 470 msec for females\] performed at screening and admission (Treatment period 1) to the clinical unit. Minor abnormalities in ECG, which are not considered to be of clinical significance by the physician investigator, are acceptable. The presence of Left Bundle Branch Block (LBBB), atrioventricular (AV) Block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator \[ICD\] will lead to exclusion
* Healthy on the basis of clinical laboratory tests performed at Screening. If the results of the serum chemistry panel \[excluding liver function tests\], hematology \[including coagulation\], or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities to be not clinically significant. This determination must be recorded in the participant's source documents and initialed/signed by the physician investigator
* Must be willing to adhere to the prohibitions and restrictions specified in this protocol
* Must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
Exclusion Criteria
* History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening
* History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening
* History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that, in the opinion of the investigator, with written concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence)
* History of at least mild drug or alcohol use disorder according to Diagnostic and Statistical Manual of Mental Disorders (latest edition DSM-5) criteria within 6 months before Screening
18 Years
55 Years
ALL
Yes
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Overland Park, Kansas, United States
Countries
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Other Identifiers
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54175446EDI1003
Identifier Type: OTHER
Identifier Source: secondary_id
CR108246
Identifier Type: -
Identifier Source: org_study_id
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