Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 61 of 395 for:    CLARITHROMYCIN

A Study to Assess Effects of Clarithromycin on Pharmacokinetics of JNJ-54861911 in Healthy Male Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02197884
Recruitment Status : Completed
First Posted : July 23, 2014
Last Update Posted : October 15, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to assess the effects of strong cytochrome P450 (CYP) 3A4 inhibitors (Itraconazole and Clarithromycin), on pharmacokinetics (PK) (study of the way a drug enters and leaves the blood and tissues over time) of single dose of JNJ-54861911 in healthy male participants.

Condition or disease Intervention/treatment Phase
Healthy Drug: JNJ-54861911, 25 mg Drug: Itraconazole 200 mg Drug: Clarithromycin 500 mg Phase 1

Detailed Description:
This is a single-center, open-label (participants and researchers are aware about the treatment, participants are receiving), fixed-sequence study in healthy male participants consisting of 2 sequential parts. For all participants enrolled in either part, the study consists of 3 phases: Screening Phase (within 21 to 2 days prior to the first dose administration on Day 1), Open-label Treatment Phase (Day 1 up to Day 12), and Follow-up Phase (7 to 14 days after last dose administration). The maximum duration of study will be 7 weeks per participant. Study will be conducted in 2 parts to understand the relative role of CYP3A4 and amide hydrolysis pathways in JNJ-54861911 metabolism and any potential drug-drug interaction liability with inhibitors of these pathways. Itraconazole will be administered in Part 1 as mixed CYP3A4 and potential amide hydrolysis inhibitor. Clarithromycin will be administered in Part 2 as a pure CYP3A4 inhibitor. However, Part 2 of the study will only be conducted if a relevant interaction is observed with itraconazole based on an interim review of Part 1 data. Participants enrolled in Part 1 will receive single dose of JNJ-54861911, 25 milligram (mg) tablet orally on Day 1 and Day 9 along with itraconazole 200 mg (2*100 mg capsule) orally once daily from Day 5 to Day 12. Participants enrolled in Part 2 will receive single dose of JNJ-54861911, 25 mg tablet orally on Day 1 and Day 9 along with clarithromycin 500 mg immediate release tablet orally twice daily from Day 5 to Day 12. Blood samples will be collected pre-dose (Day 1) up to Day 13 to understand the PK characteristics of JNJ-54861911 and diaminothiazine (DIAT, a metabolite formed after amide hydrolysis of JNJ-54861911). In addition, a blood sample will be collected on Day -1 from all enrolled participants to study genotyping of CYP3A4 gene and other genetic factors that may influence the PK, safety, and/or tolerability of JNJ-54861911 and CYP3A4 inhibitors. Participants' safety will be monitored throughout the study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Fixed-Sequence Study to Assess Effects of Clarithromycin on the Single-Dose Pharmacokinetics of JNJ-54861911 in Healthy Male Subjects
Study Start Date : July 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Itraconazole + JNJ-54861911 (Part 1)
Single dose of JNJ-54861911, 25 milligram (mg) tablet orally on Day 1 and Day 9 along with itraconazole 200 mg (2*100 mg capsule) orally once daily from Day 5 to Day 12.
Drug: JNJ-54861911, 25 mg
JNJ-54861911, 25 mg tablet orally on Day 1 and Day 9.

Drug: Itraconazole 200 mg
Itraconazole 200 mg (2*100 mg capsule) orally once daily from Day 5 to Day 12.

Experimental: Clarithromycin + JNJ-54861911 (Part 2)
Single dose of JNJ-54861911, 25 mg tablet orally on Day 1 and Day 9 along with clarithromycin 500 mg immediate release tablet orally twice daily from Day 5 to Day 12.
Drug: JNJ-54861911, 25 mg
JNJ-54861911, 25 mg tablet orally on Day 1 and Day 9.

Drug: Clarithromycin 500 mg
Clarithromycin 500 mg immediate release tablet orally twice daily from Day 5 to Day 12.




Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of JNJ-54861911 and diaminothiazine (DIAT) [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 18, 24, 36, 48, 72, 96 hours post-dose on Day 1 and 9 ]
    The Cmax is the maximum observed plasma concentration.

  2. Time to Reach Maximum Concentration (Tmax) of JNJ-54861911 and DIAT [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 18, 24, 36, 48, 72, 96 hours post-dose on Day 1 and 9 ]
    The Tmax is time to reach the maximum observed plasma concentration.

  3. Time to Last Quantifiable Plasma Concentration (Tlast) of JNJ-54861911 and DIAT [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 18, 24, 36, 48, 72, 96 hours post-dose on Day 1 and 9 ]
    The Tlast is time to last observed quantifiable plasma concentration (Clast).

  4. Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of JNJ-54861911 and DIAT [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 18, 24, 36, 48, 72, 96 hours post-dose on Day 1 and 9 ]
    The AUC (0-last) is area under the plasma concentration-time curve from time zero to time of last quantifiable concentration.

  5. Area Under the Plasma Concentration-time Curve From Time Zero to Extrapolated Infinite Time (AUC [0-infinity]) of JNJ-54861911 and DIAT [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 18, 24, 36, 48, 72, 96 hours post-dose on Day 1 and 9 ]
    The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to extrapolated infinite time, calculated as the sum of AUC (0-last) and Clast/lambda(z), where AUC (0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time; Clast is the last observed quantifiable concentration; and lambda(z) is first-order rate constant associated with the terminal portion of the semilogarithmic drug concentration-time curve.

  6. Area Under the Plasma Concentration-time Curve From Time Zero to Time 24 Hours (AUC [0-24]) of JNJ-54861911 and DIAT [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 18, 24, 36, 48, 72, 96 hours post-dose on Day 1 and 9 ]
    Area under the plasma concentration-time curve from time zero to time 24 hours.

  7. Elimination Half-Life (t1/2) of JNJ-54861911 and DIAT [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 18, 24, 36, 48, 72, 96 hours post-dose on Day 1 and 9 ]
    Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve, is calculated as 0.693 divided by lambda(z), where lambda(z) is first-order rate constant associated with the terminal portion of the curve. The t1/2 is the measure of time, for plasma concentration to decrease by one half.

  8. Elimination Rate Constant (lambda[z]) of JNJ-54861911 and DIAT [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 18, 24, 36, 48, 72, 96 hours post-dose on Day 1 and 9 ]
    Lambda(z) is first-order elimination rate constant associated with the terminal portion of the semilogarithmic drug concentration-time curve.


Secondary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Screening up to follow-up (7 to 14 days after last dose administration) ]
    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; and congenital anomaly.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Signed an informed consent document indicating they understand the purpose of and procedures required for the study, and are willing to participate in the study
  • Body mass index between 18 and 30 kilogram per square meter
  • Must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening or admission (up to Day 1 predose)
  • Man, who is sexually active with a woman of child-bearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator, and must also agree to not donate sperm during the study and for 90 days after receiving the study drug
  • Participant must be healthy on the basis of clinical laboratory tests performed at Screening and/or admission and as per investigator's judgment

Exclusion Criteria:

  • History of or current liver or renal impairment, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, dermatological or metabolic disturbances
  • Known allergies, hypersensitivity, or intolerance to JNJ-54861911 or its excipients, itraconazole (Part 1 only) or clarithromycin (Part 2 only)
  • History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening
  • History of drug or alcohol abuse within 6 months before Screening or positive test result(s) for alcohol and/or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines, benzodiazepines and cotinine) at Screening or admission
  • Smoking of cigarettes (or equivalent) and/or used nicotine based products within 3 months prior to study drug administration

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): NCT02197884


Locations
Layout table for location information
Belgium
Merksem, Belgium
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Layout table for investigator information
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02197884     History of Changes
Other Study ID Numbers: CR104763
2014-001793-33 ( EudraCT Number )
54861911ALZ1009 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: October 2014
Keywords provided by Janssen Research & Development, LLC:
Healthy
JNJ-54861911
Cytochrome P450 3A4 inhibitor
Itraconazole
Clarithromycin
Alzheimer's disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Clarithromycin
Itraconazole
Hydroxyitraconazole
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antifungal Agents
14-alpha Demethylase Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs