A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ 61393215 in Healthy Participants

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03007693
• Date of registration: 30/12/2016
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ 61393215 in Healthy Participants
• Scientific title: A Randomized, Placebo-controlled, Double-blind, Multiple Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ 61393215 in Healthy Subjects
• Date of first enrolment: January 2017
• Target sample size: 71
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03007693
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Netherlands

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy male participants between 18 and 55 years of age, inclusive

- Participants must have a body mass index (BMI) between 18.0 and 30.0 kilogram per
square meter (kg/m^2), inclusive (BMI = weight/height square)

- Participant must be healthy on the basis of physical examination, medical history,
vital signs, and 12-lead ECG [incl. QTcF less than or equal to [<=] 450 milliseconds
(msec) for males] performed at screening and admission to the clinical unit. Minor
abnormalities in electrocardiogram (ECG), which are not considered to be of clinical
significance by the investigator, are acceptable. The presence of Left Bundle Branch
Block (LBBB), AV Block (second degree or higher), or a permanent pacemaker or
implantable cardioverter defibrillator [ICD] will lead to exclusion

- 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, 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 by
the investigator

- A man who is sexually active with a woman of childbearing potential and has not had a
vasectomy must agree to use a barrier method of contraception e.g., either condom with
spermicidal foam/gel/film/cream/suppository during the study and for a minimum of 1
spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose
of study drug. All men must also not donate sperm during the study and for 3 months
after receiving the last dose of study drug. In addition, their female partner should
also use a highly effective method of contraception for at least the same duration.
Examples of highly effective contraceptives include implantable progestogen-only
hormone contraception associated with inhibition of ovulation; intrauterine device
(IUD); intrauterine hormone-releasing system (IUS); vasectomized partner; sexual
abstinence (sexual abstinence is considered a highly effective method only if defined
as refraining from heterosexual intercourse during the entire period of risk
associated with the study drug. The reliability of sexual abstinence needs to be
evaluated in relation to the duration of the study and the preferred and usual
lifestyle of the participant.), combined (estrogen- and progestogen-containing)
hormonal contraception associated with inhibition of ovulation: oral, intravaginal,
and transdermal; progestogen-only hormone contraception associated with inhibition of
ovulation: oral and injectable.

- Participants must be willing to adhere to the prohibitions and restrictions specified
in this protocol

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, though minor deviations, which are not considered to be of clinical
significance to both the investigator and to the Janssen Safety Responsible Physician,
are acceptable

- Current or past history of any psychiatric disorder as classified according to
Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) or DSM-V, with the
exclusion of an anxiety disorder (i.e., panic disorder with or without agoraphobia,
social anxiety disorder, and generalized anxiety disorder)

- Participant has any liver function test (including alanine aminotransferase [ALT],
aspartate aminotransferase [AST], gamma-glutamyltransferase [gGT], alkaline
phosphatase [ALP and bilirubin] at screening exceeding the upper limit of normal

- Participant has estimated glomerular filtration rate (eGFR) <60 milliliter per minute
(mL/min)/1.73m^2 at screening (provided by the local laboratory)

- Participant has a heart rate < 50 beats per minute (bpm) or > 100 bpm or systolic
blood pressure greater than or equal to (>=) 150 millimeter of mercury (mmHg) at
screening or at admission to the clinical unit



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Placebo

Drug: JNJ-61393215

Primary Outcome(s)

Apparent Elimination Half-Life Associated With The Terminal Slope of The Semilogarithmic Drug Concentration-Time Curve, After Multiple-Dose Administration Only (t1/2term) [Time Frame: Day 7]

Apparent Terminal Elimination Rate Constant, Determined By Linear Regression of the Terminal Points of the Ln-Linear Plasma Concentration-Time Curve (Lambda[Z]) [Time Frame: Day 7]

Fluctuation Index (FI) [Time Frame: Day 7]

Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability [Time Frame: up to 4 weeks]

Average Plasma Concentration at Steady State Over the Dosing Interval (Cavg) [Time Frame: Day 7]

Area Under the Plasma Concentration-Time Curve From Time [0 to24] (AUC[0-24]) [Time Frame: Day 1]

Ratio of Maximum Plasma Concentration (Cmax) Test (Day 7 [steady-state]/ref (Day 1) (Ratio Cmax,test/ref) [Time Frame: Day 7]

Total Apparent Oral Clearance, Calculated as Dose/AUCtau at Steady-State (CL/F) [Time Frame: Day 7]

Area Under the Plasma Concentration-Time Curve From Time [0 to24] (AUC[0-24]) [Time Frame: Day 7]

Maximum Plasma Concentration (Cmax) [Time Frame: Day 1]

Maximum Plasma Concentration (Cmax) [Time Frame: Day 7]

Minimum Observed Plasma Concentration During Dosing Interval (tau) (Cmin) [Time Frame: Day 7]

Ratio of Area Under the Plasma Concentration-Time Curve From Time [0 to24] (AUC[0-24]) Test (Day 7 [steady-state]/ref (Day 1) (Ratio AUC24h,test/ref) [Time Frame: Day 7]

The Observed Plasma Concentration Just Prior To the Beginning or at the End of a Dosing Interval of any Dose Other Than the First Dose (Ctrough) [Time Frame: Day 7]

Time To Reach The Maximum Plasma Concentration (Tmax) [Time Frame: Day 1]

Time To Reach The Maximum Plasma Concentration (Tmax) [Time Frame: Day 7]

The Observed Plasma Concentration Just Prior To the Beginning or at the End of a Dosing Interval of any Dose Other Than the First Dose (Ctrough) [Time Frame: Days 2 to 6]

Secondary Outcome(s)

Effect of JNJ-61393215 on Alertness/Sedation Through the Bond & Lader Visual Analogue Scale [Time Frame: Day 1 and Day 7]

Secondary ID(s)

61393215EDI1002

2016-003894-16

CR108250

Source(s) of Monetary Support

Please refer to primary and secondary sponsors