Study to Investigate Effects of Repeated Administration of Itraconazole on Pharmacokinetics of JNJ-42847922 in Healthy Male Participants

NCT02455856 | Completed Phase 1

• 3 other identifiers: CR10714442847922EDI10052014-005499-27
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effects of repeated once daily administration of 200 milligram (mg) of itraconazole (steady state) on the single-dose pharmacokinetics of JNJ 42847922 in healthy, male participants.

Conditions

Healthy

Keywords

Healthy; Itraconazole; JNJ-42847922

Outcome Measures

Primary Outcomes (14)

• Maximum Plasma Concentration (Cmax) of JNJ-42847922

  The Cmax is the maximum plasma concentration.

  up to Day 6

• Time to Reach Maximum Concentration (tmax) of JNJ-42847922

  The tmax is time to reach the maximum observed plasma concentration.

  up to Day 6

• Time to Reach Last Quantifiable Plasma Concentration (tlast) of JNJ-42847922

  The tmax is time to last observed quantifiable plasma concentration.

  up to Day 6

• Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of JNJ-42847922

  The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.

  up to Day 6

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-42847922

  The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.

  up to Day 6

• Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC [0-24]) of JNJ-42847922

  The AUC (0-24) is the area under the plasma concentration-time curve from time 0 to time 24 hours

  up to Day 6

• Elimination Half-Life (t [1/2] Lambda) of JNJ-42847922

  Elimination half-life (t \[1/2\] Lambda) is associated with the terminal slope (lambda \[z\]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).

  up to Day 6

• Rate Constant (Lambda[z])

  Lambda(z) is first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.

  up to Day 6

• Apparent total body clearance (CL/F) of JNJ-42847922

  Clearance is a quantitative measure of the rate at which a drug substance is removed from the body. The CL/F will be calculated by dividing the dose by AUC (0-infinity)

  up to Day 6

• Apparent volume of distribution at the terminal Phase (Vd[z] /F) of JNJ-42847922

  Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.The Vd(z)/F will be calculated by dividing CL/F by lambda(z).

  up to Day 6

• Mean Residence Time of JNJ-42847922

  Mean residence time, calculated as area under the first moment curve (AUMC\[0-infinity\]/AUC(0-infinity).

  up to Day 6

• Amount of JNJ-42847922 Excreted in Urine (Ae)

  amount excreted into the urine, calculated by multiplying the urinary volume with the urinary concentration.

  up to Day 6

• Percentage of JNJ-42847922 Dose Excreted in Urine

  Amount excreted into the urine, expressed as a percentage of the administered dose, calculated as \[Ae/dose\]\*100, and corrected for molecular weight when necessary.

  up to Day 6

• Renal Clearance

  Renal clearance calculated as Ae (total)/AUC (infinity).

  up to Day 6

Secondary Outcomes (1)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  up to End of study (7 to 14 days after lasr dose of study drug or early withdrawal)

Study Arms (1)

JNJ-42847922 plus Itraconazole

EXPERIMENTAL

Participants will receive single dose of 5 milligram (mg) JNJ-42847922 as 5 mg/milliliter \[mL\] oral solution on Day 1 and Day 6 and itraconazole as 200 mg (2\*100 mg capsule) from Day 2 to Day 6.

Drug: JNJ-42847922; Drug: Itraconazole

Interventions

JNJ-42847922 DRUG

Participants will receive single dose of 5 milligram (mg) JNJ-42847922 as 5 mg/milliliter \[mL\] oral solution on Day 1 and Day 6.

JNJ-42847922 plus Itraconazole

Itraconazole DRUG

Participants will receive single dose of itraconazole as 200 mg (2\*100 mg capsule) from Day 2 to Day 6.

JNJ-42847922 plus Itraconazole

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male participants aged between 18 and 55 years, inclusive
• Body mass index (BMI) between 18 and 30 kilogram/meter\^2 inclusive (BMI = weight/height\^2)
• Nonsmoker (not smoked for at least 3 months prior to screening)
• Men who are sexually active with a woman of childbearing potential and have not had a vasectomy must agree to use a barrier method of birth control e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and 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 partners should also use an appropriate method of birth control for at least the same duration
• Participants must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study and comply with the study procedures and restrictions

You may not qualify if:

• Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or admission
• Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening, on Day -1 or on Day 1, predose
• History of or current significant psychiatric and other illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, or any other illness that the Investigator considers should exclude the subject. History of epilepsy or fits or unexplained black-outs
• Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies (HCV) or human immunodeficiency virus (HIV) antibodies
• History of clinically significant drug and/or food allergies

Sponsors & Collaborators

• Janssen Cilag N.V./S.A.: lead

Study Sites (1)

Unknown Facility

Berlin, Germany

Location

MeSH Terms

Interventions

seltorexant; Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: May 28, 2015
• Study Start: May 18, 2015
• Primary Completion: June 19, 2015
• Study Completion: June 19, 2015
• Last Updated: July 11, 2017

Record last verified: 2017-07

Locations

DE (1)