A Study of Orally Administered Pimodivir in Adult Participants With Hepatic Impairment

Hepatic Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03816631
• Other study ID #: CR108571
• Secondary ID: 2018-002817-3663
• Status: Completed
• Phase: Phase 1
• Start date: May 28, 2019
• Est. completion date: April 27, 2020

Study information

• Verified date: July 2020
• Source: Janssen-Cilag International NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 27, 2020
• Est. primary completion date: April 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• Pimodivir
Participants will receive single oral dose of Pimodivir 600 mg (2*300 mg tablets) under fasted condition on Day 1.

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Kiel GmbH	Kiel
Germany	APEX GmbH	Munchen

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag International NV

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Analyte Concentration (Cmax) of Pimodivir	Cmax is defined as maximum observed analyte concentration of pimodivir.	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)
Primary	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.	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)
Primary	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.	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	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.	Approximately 42 days