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

NCT02930694 | Completed Phase 1

• 2 other identifiers: CR10824654175446EDI1003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• Maximum Plasma Concentration (Cmax) of JNJ-54175446

  The Cmax is the maximum observed plasma concentration.

  Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose

• Time to Reach Maximum Plasma Concentration (Tmax) of JNJ-54175446

  The Tmax is defined as actual sampling time to reach maximum plasma concentration.

  Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose

• Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of JNJ-54175446

  The AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't'.

  Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-54175446

  The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z); wherein AUC(0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

  Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose

• Elimination Rate Constant (Lambda[z]) of JNJ-54175446

  Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.

  Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose

• Elimination Half-Life (t1/2) of JNJ-54175446

  The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).

  Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose

• Relative Bioavailability of JNJ-54175446

  Relative bioavailability, calculated as individual Cmax and AUC treatment ratios (for the comparison of capsule to suspension formulation).

  Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 hour post dose

Secondary Outcomes (1)

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  Baseline up to 9 Weeks

Study Arms (4)

Group 1: Treatment Sequence AB

EXPERIMENTAL

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.

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

Group 1: Treatment Sequence BA

EXPERIMENTAL

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.

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

Group 2: Treatment Sequence CD

EXPERIMENTAL

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.

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

Group 2: Treatment Sequence DC

EXPERIMENTAL

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.

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

Interventions

JNJ-54175446 (capsule) DRUG

Participants will receive JNJ-54175446 capsule at a dose of 50 mg or 100 mg, orally.

Group 1: Treatment Sequence AB; Group 1: Treatment Sequence BA; Group 2: Treatment Sequence CD; Group 2: Treatment Sequence DC

JNJ-54175446 (suspension) DRUG

Participants will receive JNJ-54175446 suspension at a dose of 50 mg or 100 mg, orally.

Group 1: Treatment Sequence AB; Group 1: Treatment Sequence BA; Group 2: Treatment Sequence CD; Group 2: Treatment Sequence DC

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Overland Park, Kansas, United States

Location

MeSH Terms

Interventions

JNJ-54175446; Capsules; Suspensions

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Colloids; Complex Mixtures

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 12, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 16, 2017

Record last verified: 2017-02

Locations

US (1)