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

Healthy Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-55375515 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02623491
• Other study ID #: CR108063
• Secondary ID: 2015-003817-3155
• Status: Completed
• Phase: Phase 1
• First received: November 18, 2015
• Last updated: December 5, 2016
• Start date: November 2015
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Description:

This is a randomized (study medication assigned to participants by chance), double-blind (neither the investigator nor the participants know what treatment the participant is receiving), placebo-controlled (an inactive comparator treatment that has no study drug in it), single center study in healthy male participants and female participants of non-childbearing potential (surgically sterile or post menopausal), aged 18 to 58 years inclusive. This study will consist of two parts; a Single Ascending Dose (SAD) part and a Multiple Ascending Dose (MAD) part. The SAD will consist of 6 escalating dose cohorts. Participants in each cohort will be randomized to receive a single oral administration of JNJ-55375515 or placebo after an overnight fast. The planned doses of JNJ-55375515 range from 0.75 to 100 milligrams (mg). Participants in an additional cohort will be dosed in the fed state to determine the effects of food on the safety, tolerability and pharmacokinetics of JNJ-55375515. An additional optional cohort may be evaluated to further explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of JNJ-55375515, with the maximal dose not exceeding 200 mg. The study duration for participants in the SAD part of the study will be approximately 2 to 5.5 weeks, including eligibility Screening. The MAD will consist of 3 cohorts of 9 participants. Participants will receive once daily oral doses of JNJ-55375515 or placebo for 10 consecutive days. The study duration for participants in the MAD part of this study will be approximately 3 to 7 weeks including the eligibility Screening. The Safety of Participants will be monitored throughout the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 58 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-55375515
Participants will receive JNJ-55375515 at a starting dose of 0.75 milligrams (mg) and maximum escalated dose will be 200 mg.
• Placebo
Participants will receive matching placebo.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Part 1: Maximum Observed Plasma Concentration (Cmax)	The Cmax is the maximum observed concentration.	Up to Day 5	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Part 2: Maximum Observed Plasma Concentration (Cmax)	The Cmax is the maximum observed concentration.	Up to Day 15	No
Secondary	Maximum Tolerated Dose (MTD) of JNJ-55375515	The maximum tolerated dose is defined as the dose below the dose at which 2 or more subjects receiving the same dose of active study drug experience the same dose-limiting toxicity or have the same severe adverse event, or below the level at which the Investigator and Sponsor agree that an unacceptable dose-limiting toxicity has occurred in a single subject treated with active study drug.	Up to Day 5 in part 1; up to Day 15 in part 2	Yes
Secondary	Part 1: The Effect of Food on the Number of Adverse Events		Baseline up to Day 5	Yes
Secondary	Part 1: The Effect of Food on Maximum Observed Plasma Concentration (Tmax)		Baseline up to Day 5	Yes
Secondary	Part 1: The Effect of Food on Maximum Observed Plasma Concentration (Cmax)		Baseline up to Day 5	Yes
Secondary	Part 1: The Effect of Food on Elimination Half-Life (t1/2)		Baseline up to Day 5	Yes
Secondary	Part 1: The Effect of Food on Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])		Baseline up to Day 5	Yes