A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-64140284 in Healthy Participants

NCT ID: NCT03180762

Last Updated: 2018-10-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-30
• Study Completion Date: 2017-09-25

Brief Summary

The purpose of this study is to investigate the safety and tolerability of JNJ-64140284 versus placebo after single oral dose administration (ascending dose levels) under fasted condition, to characterize the pharmacokinetics (PK) of JNJ-64140284 in plasma, cerebrospinal fluid (CSF) and urine after single oral dose administration and to investigate the effect of food (high fat/high calorie) on the PK of JNJ-64140284 following single oral dose administration.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Part 1: Cohort 1 (JNJ-64140284 or Placebo)

Participants will receive 0.1 milligram (mg) JNJ-64140284 or matching placebo under fasted condition on Day 1.

Group Type: EXPERIMENTAL

JNJ-64140284 0.1 mg

Intervention Type: DRUG

0.1 mg of JNJ-64140284 will be administered as an oral solution.

Placebo

Intervention Type: DRUG

Matching placebo will be administered.

Part 1: Cohort 2 (JNJ-64140284 or Placebo)

Participants will receive 0.5 mg JNJ-64140284 or matching placebo under fasted condition on Day 1.

Group Type: EXPERIMENTAL

JNJ-64140284 0.5 mg

Intervention Type: DRUG

0.5 mg of JNJ-64140284 will be administered as an oral solution.

Placebo

Intervention Type: DRUG

Matching placebo will be administered.

Part 1: Cohort 3 (JNJ-64140284 or Placebo)

Participants will receive 2.5 mg JNJ-64140284 or matching placebo under fasted condition on Day 1.

Group Type: EXPERIMENTAL

JNJ-64140284 2.5 mg

Intervention Type: DRUG

2.5 mg of JNJ-64140284 will be administered as an oral solution.

Placebo

Intervention Type: DRUG

Matching placebo will be administered.

Part 1: Cohort 4 (JNJ-64140284 or Placebo)

Participants will receive 10 mg JNJ-64140284 or matching placebo under fasted condition on Day 1.

Group Type: EXPERIMENTAL

JNJ-64140284 10 mg

Intervention Type: DRUG

10 mg of JNJ-64140284 will be administered as an oral solution.

Placebo

Intervention Type: DRUG

Matching placebo will be administered.

Part 1: Cohort 5 (JNJ-64140284 or Placebo)

Participants will receive 50 mg JNJ-64140284 or matching placebo under fasted condition on Day 1.

Group Type: EXPERIMENTAL

JNJ-64140284 50 mg

Intervention Type: DRUG

50 mg of JNJ-64140284 will be administered as an oral solution.

Placebo

Intervention Type: DRUG

Matching placebo will be administered.

Part 1: Cohort 6 (JNJ-64140284 or Placebo)

Participants will receive 150 mg JNJ-64140284 or matching placebo under fasted condition on Day 1.

Group Type: EXPERIMENTAL

JNJ-64140284 150 mg

Intervention Type: DRUG

150 mg of JNJ-64140284 will be administered as an oral solution.

Placebo

Intervention Type: DRUG

Matching placebo will be administered.

Part 2: Cohort 7 (JNJ-64140284)

Participants will receive JNJ-64140284 (dose to be determined - the dose of JNJ-64140284 will be determined on the basis of acceptable safety, tolerability and pharmacokinetics \[PK\] of preceding dose levels; no more than 50 percent (%) of the highest dose tested \[though as high as possible within this restriction\] and considered well tolerated in Part 1) under fed conditions on Day 1.

Group Type: EXPERIMENTAL

JNJ-64140284 (dose to be determined [TBD])

Intervention Type: DRUG

JNJ-64140284 (dose to be determined) will be administered as an oral solution.

Part 3: Cohort 8 (JNJ-64140284 or Placebo)

Participants will receive JNJ-64140284 or matching placebo (dose to be determined - dose will be determined based on PK data from previous cohorts and which will be well-tolerated in Part 1) under fasted condition on Day 1.

Group Type: EXPERIMENTAL

JNJ-64140284 (dose to be determined [TBD])

Intervention Type: DRUG

JNJ-64140284 (dose to be determined) will be administered as an oral solution.

Placebo

Intervention Type: DRUG

Matching placebo will be administered.

Interventions

JNJ-64140284 0.1 mg

0.1 mg of JNJ-64140284 will be administered as an oral solution.

Intervention Type: DRUG

JNJ-64140284 0.5 mg

0.5 mg of JNJ-64140284 will be administered as an oral solution.

Intervention Type: DRUG

JNJ-64140284 2.5 mg

2.5 mg of JNJ-64140284 will be administered as an oral solution.

Intervention Type: DRUG

JNJ-64140284 10 mg

10 mg of JNJ-64140284 will be administered as an oral solution.

Intervention Type: DRUG

JNJ-64140284 50 mg

50 mg of JNJ-64140284 will be administered as an oral solution.

Intervention Type: DRUG

JNJ-64140284 150 mg

150 mg of JNJ-64140284 will be administered as an oral solution.

Intervention Type: DRUG

JNJ-64140284 (dose to be determined [TBD])

JNJ-64140284 (dose to be determined) will be administered as an oral solution.

Intervention Type: DRUG

Placebo

Matching placebo will be administered.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Part 1 and 2:

• Healthy male participants between 18 and 58 years of age, inclusive

Part 1, 2 and 3:

• Participants must 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, retesting of an abnormal lab value(s) that may lead to exclusion will be allowed once during the screening phase. The participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study according to both the investigator and to the Janssen Safety Physician, are acceptable

Part 3:

• Healthy male and female participants between 59 and 75 years of age, inclusive
• Participants must be healthy and medically stable on the basis of clinical laboratory tests (at screening) and physical and neurological examination (at screening and at admission to the clinical unit). If the participant is medically stable with medication, inclusion can be allowed on a case by case basis with written agreement of the sponsor's responsible safety physician
• Women must not be of childbearing potential (must be postmenopausal with amenorrhea for at least 12 months) or permanently sterilized (for example, tubal occlusion, hysterectomy, bilateral salpingectomy)

Exclusion Criteria

Part 1, 2 and 3:

• Participants with a history of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, or any other illness that the Investigator considers should exclude the participant
• Participants with a serology positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies
• Participants with a clinically significant acute illness within 7 days prior to study drug administration
• Donation of 1 or more units (approximately 450 milliliter [mL]) of blood or acute loss of an equivalent amount of blood within 90 days prior to study drug administration

Part 3:

• participants having a contraindication for spinal puncture including:

1. A relevant history of lower back pain or scoliosis or kyphosis and/or major (lumbar) back surgery (microdiscectomy is allowed) in the opinion of the investigator

2. Allergy to local anesthetics and/or iodine/disinfectants

3. Clinically significant abnormal values for coagulation at screening

4. Use of aspirin (even low dose) within 5 days prior to lumbar puncture

5. Use of low molecular weight heparin (LMWH) within 12 hours prior to lumbar puncture

6. Use of any anticoagulant treatment (besides LMWH described above) within 1 week prior to lumbar puncture

7. Has a topical infection or local dermatological condition at the puncture site prior to puncture

8. Has papilloedema or signs of increased intracranial pressure based on fundoscopy at screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Clinical Pharmacology Unit

Merksem, , Belgium

Countries

Belgium

Other Identifiers

2017-000283-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

64140284EDI1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108318

Identifier Type: -

Identifier Source: org_study_id