Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-55375515 in Healthy Participants

NCT02623491 | Completed Phase 1

• 3 other identifiers: CR1080632015-003817-3155375515EDI1001
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of JNJ-55375515 in healthy participants after administration of single and multiple oral doses.

Conditions

Healthy

Keywords

JNJ-55375515; Healthy; Placebo

Outcome Measures

Primary Outcomes (9)

• Number of Participants with Adverse Events

  An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  Up to Day 7 after discharge

• Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax)

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

  Up to Day 5

• Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])

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

  Up to Day 5

• Part 1: Elimination Half-Life (t1/2)

  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).

  Up to Day 5

• Part 1: Maximum Observed Plasma Concentration (Cmax)

  The Cmax is the maximum observed concentration.

  Up to Day 5

• Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax)

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

  Up to Day 15

• Part 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])

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

  Up to Day 15

• Part 2: Elimination Half-Life (t1/2)

  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).

  Up to Day 15

• Part 2: Maximum Observed Plasma Concentration (Cmax)

  The Cmax is the maximum observed concentration.

  Up to Day 15

Secondary Outcomes (6)

• Maximum Tolerated Dose (MTD) of JNJ-55375515

  Up to Day 5 in part 1; up to Day 15 in part 2

• Part 1: The Effect of Food on the Number of Adverse Events

  Baseline up to Day 5

• Part 1: The Effect of Food on Maximum Observed Plasma Concentration (Tmax)

  Baseline up to Day 5

• Part 1: The Effect of Food on Maximum Observed Plasma Concentration (Cmax)

  Baseline up to Day 5

• Part 1: The Effect of Food on Elimination Half-Life (t1/2)

  Baseline up to Day 5

Study Arms (2)

Part 1: Single Ascending Dose (SAD)

EXPERIMENTAL

Participants will receive 0.75 milligrams (mg) of JNJ-55375515 (starting dose) or Placebo on Day 1. Dose of the study medication will be escalated sequentially up to a maximum of 200 mg.

Drug: JNJ-55375515; Drug: Placebo

Part 2: Multiple Ascending Dose (MAD)

EXPERIMENTAL

Participants will receive JNJ-55375515 (at doses determined based on the data from the SAD part) or Placebo from Day 1 to 10.

Drug: JNJ-55375515; Drug: Placebo

Interventions

JNJ-55375515 DRUG

Participants will receive JNJ-55375515 at a starting dose of 0.75 milligrams (mg) and maximum escalated dose will be 200 mg.

Part 1: Single Ascending Dose (SAD); Part 2: Multiple Ascending Dose (MAD)

Placebo DRUG

Participants will receive matching placebo.

Part 1: Single Ascending Dose (SAD); Part 2: Multiple Ascending Dose (MAD)

Eligibility Criteria

• Age: 18 Years - 58 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant must be healthy on the basis of physical and neurological examination, medical history, vital signs, and electrocardiogram (ECG), and have a body mass index of 18-30 kilogram / square meter (kg/m\^2) and a body mass of not less than 50 kg.
• Participant must be healthy on the basis of clinical laboratory tests performed at Screening and Day -1.
• Female participants must not be of childbearing potential by either being post-menopausal or permanently sterilized.
• Female participants must not be pregnant.
• Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, including contraception.
• Each participant 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:

• Participant has current, or history of, clinically significant medical or psychiatric illness.
• Participant has any condition for which participation would not be in the best interest of the participant or that could prevent, limit, or confound any protocol specified assessments or the interpretation of the study results.
• Participant has a personal history of, or a first degree relative with a history of, acute angle-closure glaucoma, or participant has significant hyperopia (far-sightedness).
• Participant has a QT corrected according to Fridericia's formula (QTcF) interval greater than (\>) 450 msec (male) or \>470 msec (female), or has a history of additional risk factors for torsades de pointes.
• Participant has history of vasovagal episodes.
• Participant has history of drug, alcohol, nicotine, or caffeine abuse.
• Participant who is breastfeeding.
• Participant has had major surgery within 12 weeks of Screening, has donated more than 450 milliliters (mL) of blood, or has acute loss of equivalent amount of blood within 90 days of study drug administration.
• Participant has positive fecal occult blood test results at Screening.
• Participant has history of clinically significant drug and/or food allergies.
• Participant has received another investigational drug within 1 month or a period of less than 10 times the drug's half-life, whichever is longer, before the planned first dose of study drug
• Participant is an employee, or family member of an employee, of the study site.

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: December 7, 2015
• Study Start: November 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 6, 2016

Record last verified: 2016-12

Locations

BE (1)