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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: JNJ-54175446 (capsule); Drug: JNJ-54175446 (suspension)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02930694

54175446EDI1003 (Other Identifier)

CR108246

Details and patient eligibility

About

The primary purpose of the study is to investigate the plasma pharmacokinetics and bioavailability (BA) of a single dose of a solid dose formulation with 2 different strengths of JNJ-54175446 (50 milligram [mg] and 100 mg capsules) relative to the suspension of JNJ-54175446 under fasting conditions.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A body mass index (BMI) between 18 and 32 kilogram per square meter (kg/m^2), inclusive (BMI = weight/height^2)
• 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 or current liver or renal insufficiency (estimated creatinine clearance below 60 milliliter per minute [mL/min]); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic (including coagulation disorders), rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness that the Investigator considers should exclude the participant
• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Group 1: Treatment Sequence AB

Experimental group

Description:

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.

Treatment:

Drug: JNJ-54175446 (suspension)

Drug: JNJ-54175446 (capsule)

Group 1: Treatment Sequence BA

Experimental group

Description:

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.

Treatment:

Drug: JNJ-54175446 (suspension)

Drug: JNJ-54175446 (capsule)

Group 2: Treatment Sequence CD

Experimental group

Description:

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.

Treatment:

Drug: JNJ-54175446 (suspension)

Drug: JNJ-54175446 (capsule)

Group 2: Treatment Sequence DC

Experimental group

Description:

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.

Treatment:

Drug: JNJ-54175446 (suspension)

Drug: JNJ-54175446 (capsule)