Back to resultsA Study of Orally Administered Pimodivir in Adult Participants With Hepatic Impairment
Primary Purpose
Hepatic Impairment
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Pimodivir
Sponsored by
About this trial
This is an interventional other trial for Hepatic Impairment
Eligibility 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
Sites / Locations
- CRS Clinical Research Services Kiel GmbH
- APEX GmbH
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Part A: Group 1: Severe hepatic function
Part A and B: Group 2: Normal hepatic function
Part B: Group 3: Moderate hepatic function
Part B: Group 4: Mild hepatic function
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Maximum Observed Analyte Concentration (Cmax) of Pimodivir
Cmax is defined as maximum observed analyte concentration of pimodivir.
Area Under Concentration-Time Curve from Time 0 to the Time of the Last Concentration (AUC[last]) of Pimodivir
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.
Area Under Concentration-Time Curve from Time 0 to Infinite Time (AUC[0-infinity]) of Pimodivir
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
Number of Participants with Adverse Event as a Measure of Safety and Tolerability
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.
Full Information
NCT ID
NCT03816631
First Posted
January 23, 2019
Last Updated
July 7, 2020
Sponsor
Janssen-Cilag International NV
1. Study Identification
Unique Protocol Identification Number
NCT03816631
Brief Title
A Study of Orally Administered Pimodivir in Adult Participants With Hepatic Impairment
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 28, 2019 (Actual)
Primary Completion Date
April 27, 2020 (Actual)
Study Completion Date
April 27, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen-Cilag International NV
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part A: Group 1: Severe hepatic function
Arm Type
Experimental
Arm Description
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.
Arm Title
Part A and B: Group 2: Normal hepatic function
Arm Type
Experimental
Arm Description
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.
Arm Title
Part B: Group 3: Moderate hepatic function
Arm Type
Experimental
Arm Description
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.
Arm Title
Part B: Group 4: Mild hepatic function
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pimodivir
Other Intervention Name(s)
JNJ-63623872
Intervention Description
Participants will receive single oral dose of Pimodivir 600 mg (2*300 mg tablets) under fasted condition on Day 1.
Primary Outcome Measure Information:
Title
Maximum Observed Analyte Concentration (Cmax) of Pimodivir
Description
Cmax is defined as maximum observed analyte concentration 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)
Title
Area Under Concentration-Time Curve from Time 0 to the Time of the Last Concentration (AUC[last]) of Pimodivir
Description
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.
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)
Title
Area Under Concentration-Time Curve from Time 0 to Infinite Time (AUC[0-infinity]) of Pimodivir
Description
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.
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)
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Event as a Measure of Safety and Tolerability
Description
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.
Time Frame
Approximately 42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen-Cilag International NV Clinical Trial
Organizational Affiliation
Janssen-Cilag International NV
Official's Role
Study Director
Facility Information:
Facility Name
CRS Clinical Research Services Kiel GmbH
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
APEX GmbH
City
Munchen
ZIP/Postal Code
81241
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Learn more about this trial
A Study of Orally Administered Pimodivir in Adult Participants With Hepatic Impairment
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