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Trial record 72 of 205 for:    SPORANOX I.V. OR ITRACONAZOLE OR ONMEL OR SPORANOX-PULSE OR Sporanos OR R 51,211 OR SPORANOX

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

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ClinicalTrials.gov Identifier: NCT02455856
Recruitment Status : Completed
First Posted : May 28, 2015
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Cilag N.V./S.A.

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: JNJ-42847922 Drug: Itraconazole Phase 1

Detailed Description:

This is an open-label (all people know the identity of the intervention), fixed-sequence, single-center, single-dose study designed to assess the effects of steady-state itraconazole exposure on the pharmacokinetics of a single oral dose of JNJ 42847922 in healthy male participants. The duration of study will be approximately of 6 weeks per participant. The study consists of 3 parts: Screening (that is, 21 days before study commences on Day 1); Open-label Treatment (6 days); and Follow-up (7 to 14 days after last dose of study drug or early withdrawal).

All eligible participants will receive single oral doses of 5 milligram (mg) JNJ-42847922 on Day 1 and Day 6. A daily dose of 200 mg itraconazole will be administered from Day 2 to Day 6. Followed by an overnight fast of at least 8 hours participants will be administered with study treatment 30 minutes after light breakfast. Participants will not be allowed to have food until 4 hours of drug administration. Blood samples will be collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment. Participants' safety will be monitored throughout the study.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Investigate the Potential Effects of Repeated Administration of Itraconazole on the Pharmacokinetics of JNJ-42847922 in Healthy Male Subjects
Actual Study Start Date : May 18, 2015
Actual Primary Completion Date : June 19, 2015
Actual Study Completion Date : June 19, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: JNJ-42847922 plus Itraconazole
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
Participants will receive single dose of 5 milligram (mg) JNJ-42847922 as 5 mg/milliliter [mL] oral solution on Day 1 and Day 6.

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




Primary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) of JNJ-42847922 [ Time Frame: up to Day 6 ]
    The Cmax is the maximum plasma concentration.

  2. Time to Reach Maximum Concentration (tmax) of JNJ-42847922 [ Time Frame: up to Day 6 ]
    The tmax is time to reach the maximum observed plasma concentration.

  3. Time to Reach Last Quantifiable Plasma Concentration (tlast) of JNJ-42847922 [ Time Frame: up to Day 6 ]
    The tmax is time to last observed quantifiable plasma concentration.

  4. Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of JNJ-42847922 [ Time Frame: up to Day 6 ]
    The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.

  5. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-42847922 [ Time Frame: up to Day 6 ]
    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.

  6. Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC [0-24]) of JNJ-42847922 [ Time Frame: up to Day 6 ]
    The AUC (0-24) is the area under the plasma concentration-time curve from time 0 to time 24 hours

  7. Elimination Half-Life (t [1/2] Lambda) of JNJ-42847922 [ Time Frame: up to Day 6 ]
    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).

  8. Rate Constant (Lambda[z]) [ Time Frame: up to Day 6 ]
    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.

  9. Apparent total body clearance (CL/F) of JNJ-42847922 [ Time Frame: up to Day 6 ]
    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)

  10. Apparent volume of distribution at the terminal Phase (Vd[z] /F) of JNJ-42847922 [ Time Frame: up to Day 6 ]
    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).

  11. Mean Residence Time of JNJ-42847922 [ Time Frame: up to Day 6 ]
    Mean residence time, calculated as area under the first moment curve (AUMC[0-infinity]/AUC(0-infinity).

  12. Amount of JNJ-42847922 Excreted in Urine (Ae) [ Time Frame: up to Day 6 ]
    amount excreted into the urine, calculated by multiplying the urinary volume with the urinary concentration.

  13. Percentage of JNJ-42847922 Dose Excreted in Urine [ Time Frame: up to Day 6 ]
    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.

  14. Renal Clearance [ Time Frame: up to Day 6 ]
    Renal clearance calculated as Ae (total)/AUC (infinity).


Secondary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: up to End of study (7 to 14 days after lasr dose of study drug or early withdrawal) ]
    An AE was 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. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02455856


Locations
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Germany
Berlin, Germany
Sponsors and Collaborators
Janssen Cilag N.V./S.A.

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Responsible Party: Janssen Cilag N.V./S.A.
ClinicalTrials.gov Identifier: NCT02455856     History of Changes
Other Study ID Numbers: CR107144
42847922EDI1005 ( Other Identifier: Janssen Cilag N.V./S.A., Belgium )
2014-005499-27 ( EudraCT Number )
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Cilag N.V./S.A.:
Healthy
Itraconazole
JNJ-42847922

Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors