A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-55308942 in Healthy Male and Female 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-55308942 in Healthy Male and Female Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03151486
• Other study ID #: CR108293
• Secondary ID: 2017-000303-2555
• Status: Completed
• Phase: Phase 1
• First received: April 26, 2017
• Last updated: April 17, 2018
• Start date: May 3, 2017
• Est. completion date: March 8, 2018

Study information

• Verified date: April 2018
• Source: Janssen-Cilag International NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of JNJ-55308942 in healthy participants after administration of single and multiple oral doses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 8, 2018
• Est. primary completion date: March 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 58 Years

Eligibility

Inclusion Criteria:

• Participant must have a body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m^2) (BMI = weight [kg] / height [m]^2), and a body weight of not less than 50 kilogram (kg)

• Participant must be healthy on the basis of physical examination, neurological examination, medical history, vital signs, and 12 lead (electrocardiogram) ECG, and peripheral capillary oxygen saturation [(SpO2) greater than or equal to (>=) 97 percent] performed at Screening and Day -1

• Participant must be healthy on the basis of clinical laboratory tests performed at Screening and Day -1. If the results of the serum chemistry panel, coagulation, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator

• Female participants must not be of childbearing potential by fulfilling 1 of the criteria: a) be over 45 years of age with no menses for 12 months without an alternative medical cause, with screening follicle stimulating hormone (FSH) levels of greater than (>) 40 International Unit per Liter (IU/L) or milli-International Unit per milliliter (mIU/mL). b) be permanently surgically sterile. Permanent surgical sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy. Documentation of FSH levels is not required in the case of surgical sterility

• Female participants must have a negative serum pregnancy (Beta -human chorionic gonadotropin [Beta -hCG]) test at screening and a negative urine pregnancy test on Day -1

Exclusion Criteria:

• Participant has current, or history of, clinically significant medical illness including, but not limited to, liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances

• Participant has a history of abnormal bleeding or clotting, or disorder of fibrinogen (example, dysfibrinogenemia, hypofibrinogenemia)

• Participant has history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's medical monitor, is considered cured with minimal risk of recurrence)

• Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 1 month or within a period of less than 10 times the drug's half-life, whichever is longer, before the planned first dose of study drug, or is currently enrolled in another investigational study

• Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 5 years before Screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines, ecstasy, phencyclidine, tricyclic antidepressants, and benzodiazepines) at Screening

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-55308942 0.5 mg
Participants will receive JNJ-55308942 0.5 mg as an oral solution after an overnight fast on Day 1.
• JNJ-55308942 1.5 mg
Participants will receive JNJ-55308942 1.5 mg as an oral solution after an overnight fast on Day 1.
• JNJ-55308942 4 mg
Participants will receive JNJ-55308942 4 mg as an oral solution after an overnight fast on Day 1.
• JNJ-55308942 12 mg
Participants will receive JNJ-55308942 12 mg as an oral solution after an overnight fast on Day 1.
• JNJ-55308942 36 mg
Participants will receive JNJ-55308942 36 mg as an oral solution after an overnight fast on Day 1.
• JNJ-55308942 100 mg
Participants will receive a single oral dose of JNJ-55308942 100 mg as an oral solution after an overnight fast on Day 1.
• JNJ-55308942: Fed State
Participants will receive JNJ-55308942 as an oral solution in fed state on Day 1. The dose selected for this cohort will be based on the data obtained from the single ascending dose cohorts.
• JNJ-55308942: MAD Part
Participants will receive JNJ-55308942 once daily as an oral solution for 10 consecutive days (Day 1 to 10). The doses for the MAD will be determined based on the data from the SAD part.
• Placebo
Participants will receive matching placebo in all cohorts.

Locations

Country	Name	City	State
Belgium	Clinical Pharmacology Unit	Merksem

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag International NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.	Up to 6 Weeks
Primary	Single Ascending Dose (SAD): Maximum Observed Plasma Concentration (Cmax) of JNJ-55308942	The Cmax is the maximum observed plasma concentration of JNJ-55308942.	Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1
Primary	SAD: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-55308942	Tmax is defined as time to reach the maximum observed plasma JNJ-55308942 concentration.	Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1
Primary	SAD: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC [0-24]) of JNJ-55308942	AUC (0-24h) is defined as area under the plasma JNJ-55308942 concentration-time curve from time 0 to 24 hours postdose.	Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1
Primary	SAD: Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Observed Quantifiable Concentration (AUC [0-Last]) of JNJ-55308942	AUC (0-last) is defined as area under the plasma JNJ-53308942 concentration-time curve from time 0 to time of the last observed quantifiable concentration.	Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1
Primary	SAD: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-55308942	AUC (0-infinity) is defined as area under the plasma JNJ-55308942 concentration-time curve from time 0 to infinite time.	Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1
Primary	SAD: Area Under the Plasma JNJ-55308942 Concentration-time Curve During a Dosing Interval (t) at steady-state (AUC tau)	AUC tau is defined as area under the plasma JNJ-55308942 concentration-time curve during a dosing interval (tau) at steady-state.	Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1
Primary	SAD: Apparent elimination Half-Life (t1/2) of JNJ-55308942	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).	Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1
Primary	Multiple Ascending Dose (MAD): Maximum Observed Plasma Concentration (Cmax) of JNJ-55308942 on Day 1	The Cmax is the maximum observed plasma concentration of JNJ-55308942.	Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 16 hours postdose on Day 1
Primary	MAD: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-55308942 on Day 1	Tmax is defined as time to reach the maximum observed plasma JNJ-55308942 concentration.	Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 16 hours postdose on Day 1
Primary	MAD: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC [0-24]) of JNJ-55308942 on Day 1	AUC (0-24h) is defined as area under the plasma JNJ-55308942 concentration-time curve from time 0 to 24 hours postdose.	Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1
Primary	MAD: Apparent elimination Half-Life (t1/2) of JNJ-55308942 on Day 1	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).	Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 16 hours postdose on Day 1
Primary	MAD: Maximum Observed Plasma Concentration (Cmax) of JNJ-55308942 After Dosing on Day 10	The Cmax is the maximum observed plasma concentration of JNJ-55308942.	Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours postdose on Day 10
Primary	MAD: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-55308942 After Dosing on Day 10	Tmax is defined as time to reach the maximum observed plasma JNJ-55308942 concentration.	Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours postdose on Day 10
Primary	MAD: Area Under the Plasma JNJ-55308942 Concentration-time Curve During a Dosing Interval (t) at steady-state (AUC tau) After Dosing on Day 10	AUC tau is defined as area under the plasma JNJ-55308942 concentration-time curve during a dosing interval (tau) at steady-state.	Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours postdose on Day 10
Primary	MAD: Apparent Elimination Half-Life (t1/2) of JNJ-55308942 After Dosing on Day 10	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).	Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours postdose on Day 10