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Trial record 1 of 7 for:    Pimodivir
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A Study of Orally Administered Pimodivir in Adult Participants With Hepatic Impairment

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03816631
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV

Brief Summary:
The purpose is to evaluate the pharmacokinetics (PK) of a single oral dose of 600 milligram (mg) pimodivir in adult participants with impaired hepatic function compared to adult participants with normal hepatic function.

Condition or disease Intervention/treatment Phase
Hepatic Impairment Drug: Pimodivir Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1, Open-label, Single-dose Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Orally Administered Pimodivir in Adult Subjects
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : June 15, 2020

Arm Intervention/treatment
Experimental: Part A: Group 1: Severe hepatic function
Participants with severe hepatic function will receive single oral dose of pimodivir 600 milligram (mg) (2*300 mg tablet) under fasted condition on Day 1.
Drug: Pimodivir
Participants will receive single oral dose of Pimodivir 600 mg (2*300 mg tablets) under fasted condition on Day 1.
Other Name: JNJ-63623872

Experimental: Part A and B: Group 2: Normal hepatic function
Participants with normal hepatic function will receive single oral dose of pimodivir 600 mg (2*300 mg tablet) under fasted condition on Day 1. The recruitment in Part B will be started based on assessment by Sponsor upon evaluation of partial data obtained in Part A.
Drug: Pimodivir
Participants will receive single oral dose of Pimodivir 600 mg (2*300 mg tablets) under fasted condition on Day 1.
Other Name: JNJ-63623872

Experimental: Part B: Group 3: Moderate hepatic function
Participants with moderate hepatic function will receive single oral dose of pimodivir 600 mg (2*300 mg tablet) under fasted condition on Day 1. The recruitment in Part B will be started based on assessment by Sponsor upon evaluation of partial data obtained in Part A.
Drug: Pimodivir
Participants will receive single oral dose of Pimodivir 600 mg (2*300 mg tablets) under fasted condition on Day 1.
Other Name: JNJ-63623872

Experimental: Part B: Group 4: Mild hepatic function
Participants with mild hepatic function will receive single oral dose of Pimodivir 600 mg (2*300 mg tablet) under fasted condition on Day 1. The recruitment in Part B will be started based on assessment by Sponsor upon evaluation of partial data obtained in Part A.
Drug: Pimodivir
Participants will receive single oral dose of Pimodivir 600 mg (2*300 mg tablets) under fasted condition on Day 1.
Other Name: JNJ-63623872




Primary Outcome Measures :
  1. Maximum Observed Analyte Concentration (Cmax) of Pimodivir [ Time Frame: Predose, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120 hours post dose and end of study (up to Day 14) ]
    Cmax is defined as maximum observed analyte concentration of pimodivir.

  2. Area Under Concentration-Time Curve from Time 0 to the Time of the Last Concentration (AUC[last]) of Pimodivir [ Time Frame: Predose, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120 hours post dose and end of study (up to Day 14) ]
    AUC(last) is defined as the time 0 to the time of the last measurable (non-below quantification limit) concentration of Pimodivir calculated by linear-linear trapezoidal summation.

  3. Area Under Concentration-Time Curve from Time 0 to Infinite Time (AUC[0-infinity]) of Pimodivir [ Time Frame: Predose, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120 hours post dose and end of study (up to Day 14) ]
    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 the time of the last measurable concentration, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.


Secondary Outcome Measures :
  1. Number of Participants with Adverse Event as a Measure of Safety and Tolerability [ Time Frame: Approximately 42 days ]
    An adverse event is 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.



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.


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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant must have a stable hepatic function as confirmed by albumin levels, prothrombin time (PT), International Normalized Ratio (INR), and platelet count measured during screening and those measured within 24 hours prior to study drug administration. Participants with a Transjugular Intrahepatic Portosystemic Shunt procedure will be allowed to participate in the study
  • Participant must have a body mass index (BMI; weight [Kilogram {kg}/height^2 [meter {m}^2]) between 18.0 and 38.0 kg/m^2, extremes included, and body weight not less than 50 kg at screening
  • Participant must have a 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function at screening, including: (a) Sinus rhythm; (b) Pulse rate between 45 and 100 beats per minute (bpm); (c) QT interval corrected for heart rate (QTc) according to Fridericia formula (QTcF) less than or equal to (<=) 450 millisecond (ms) for male participant and <= 470 ms for female participant; (d) QRS interval of less than (<) 120 ms; (e) PR interval <= 220 ms and (f) Electrocardiogram morphology consistent with healthy cardiac conduction and function. Participant with pacemaker is eligible as long as all criteria mentioned above are met
  • A woman, except if postmenopausal, must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test on Day -1
  • Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies

Exclusion Criteria:

  • Participant has known allergies, hypersensitivity, or intolerance to pimodivir or its excipients
  • Participant has donated blood or blood products or had substantial loss of blood (more than 500 milliliter [mL]) within 3 months before administration of the study drug or intention to donate blood or blood products during the study
  • Participant has received an experimental drug (including investigational vaccines) or used an experimental medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before administration of the study drug is scheduled
  • Participant has preplanned surgery or procedures that would interfere with the conduct of the study
  • Participant is a woman who is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or a woman of childbearing potential who is unwilling to use an acceptable method of contraception

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): NCT03816631


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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Germany
CRS Clinical Research Services Kiel GmbH Recruiting
Kiel, Germany, 24105
APEX GmbH Recruiting
Munchen, Germany, 81241
Sponsors and Collaborators
Janssen-Cilag International NV
Investigators
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Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV
Additional Information:
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Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT03816631    
Other Study ID Numbers: CR108571
2018-002817-36 ( EudraCT Number )
63623872FLZ1013 ( Other Identifier: Janssen-Cilag International NV )
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases