A Study in Healthy Participants to Evaluate the Effect of JNJ-54175446 on Amyloid Biomarkers and Cytokine Profiles in Cerebrospinal Fluid and Plasma

NCT ID: NCT02933762

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2016-11-30

Brief Summary

The primary purpose of this study is to investigate the effects of JNJ-54175446 (dose response) on levels of Aβ fragments (Aβ1-42, Aβ1-40, Aβ1-38, Aβ1-37) in plasma and cerebrospinal fluid (CSF), the effects of JNJ-54175446 on markers of (neuro) inflammation/protection in blood and CSF and the pharmacokinetics of JNJ-54175446 followed by single and multiple dose administration.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Part 1: Cohort A1 (JNJ-54175446 30 milligram[mg])

Healthy elderly participants will receive single dose of 30mg JNJ-54175446.

Group Type: EXPERIMENTAL

JNJ-54175446

Intervention Type: DRUG

Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2.

Part 1: Cohort A1 (JNJ-54175446 100mg)

Healthy elderly participants will receive single dose of 100mg JNJ-54175446.

Group Type: EXPERIMENTAL

JNJ-54175446

Intervention Type: DRUG

Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2.

Part 1: Cohort A1 (JNJ-54175446 300mg)

Healthy elderly participants will receive single dose of 300mg JNJ-54175446.

Group Type: EXPERIMENTAL

JNJ-54175446

Intervention Type: DRUG

Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2.

Part 1: Cohort A1 (Placebo)

Healthy elderly participants will receive single dose of placebo.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2.

Part 1: Cohort A2 (JNJ-54175446 D1 mg)

Healthy elderly participants will receive an additional dose D1 mg \[less than or equal to (\<=) 600 mg\] of JNJ-54175446, to be determined.

Group Type: EXPERIMENTAL

JNJ-54175446

Intervention Type: DRUG

Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2.

Part 1: Cohort A3 (JNJ-54175446 D2 mg)

Healthy young participants will receive a single dose D2 mg (\<= 600 mg) of JNJ-54175446, to be determined.

Group Type: EXPERIMENTAL

JNJ-54175446

Intervention Type: DRUG

Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2.

Part 1: Cohort A3 (Placebo)

Healthy young participants will receive a single dose of placebo.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2.

Part 2: Cohort B1 (JNJ-54175446 D3 mg)

Healthy elderly participants will receive multiple dose levels D3 mg (\<= 450 mg) of JNJ-54175446 determined based on the results from Cohort A1.

Group Type: EXPERIMENTAL

JNJ-54175446

Intervention Type: DRUG

Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2.

Part 2: Cohort B1 (Placebo)

Healthy elderly participants will receive placebo determined based on the results from Cohort A1.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2.

Part 2: Cohort B2 (JNJ-54175446 D4 mg)

Healthy elderly participants will receive multiple dose levels D4 mg (\<= 450 mg) of JNJ-54175446 determined based on the results from Cohort A1.

Group Type: EXPERIMENTAL

JNJ-54175446

Intervention Type: DRUG

Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2.

Part 2: Cohort B2 (Placebo)

Healthy elderly participants will receive placebo determined based on the results from Cohort A1

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2.

Part 2: Cohort B3 (JNJ-54175446 D5 mg)

Healthy elderly participants will receive multiple dose levels D5 mg (\<= 450 mg) of JNJ-54175446 determined based on the results from Cohort A1.

Group Type: EXPERIMENTAL

JNJ-54175446

Intervention Type: DRUG

Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2.

Part 2: Cohort B3 (Placebo)

Healthy elderly participants will receive placebo determined based on the results from Cohort A1

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2.

Interventions

JNJ-54175446

Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2.

Intervention Type: DRUG

Placebo

Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants must have a body mass index (BMI) between 18 and 32 kilogram (kg)/ meter (m)^2, inclusive (BMI = weight/height^2)
• Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG)

Part 1 and 2 (Elderly Participants):

• Healthy male or female participants between 55 and 75 years of age, inclusive
• Participant must be healthy on the basis of both physical and neurological examination performed at Screening and at admission to the clinical unit

Part 1 (Young Participants):

• Healthy male participants between 18 and 45 years of age, inclusive

Exclusion Criteria

• Participant has a history of or current liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness that the Investigator considers should exclude the participant
• Participant has a 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 (per Screening evaluations)
• Participant has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening (per Screening evaluations)
• Participant has a history of malignancy within 5 years before Screening
• Participant has 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

Merksem, , Belgium

Countries

Belgium

References

Triana-Baltzer G, Timmers M, De Boer P, Schoene M, Furey M, Bleys C, Vrancken I, Slemmon R, Ceusters M, van Nueten L, Kolb H. Profiling classical neuropsychiatric biomarkers across biological fluids and following continuous lumbar puncture: A guide to sample type and time. Compr Psychoneuroendocrinol. 2022 Jan 15;10:100116. doi: 10.1016/j.cpnec.2022.100116. eCollection 2022 May.

Reference Type: DERIVED

PMID: 35774109 (View on PubMed)

Other Identifiers

2016-003040-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

54175446EDI1005

Identifier Type: OTHER

Identifier Source: secondary_id

CR108231

Identifier Type: -

Identifier Source: org_study_id