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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: Pimodivir

Study type: Interventional

Funder types: Industry

Identifiers

NCT03816631

CR108571

2018-002817-36 (EudraCT Number)

63623872FLZ1013 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 4 patient groups

Part A: Group 1: Severe hepatic function

Experimental group

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.

Treatment:

Drug: Pimodivir

Part A and B: Group 2: Normal hepatic function

Experimental group

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.

Treatment:

Drug: Pimodivir

Part B: Group 3: Moderate hepatic function

Experimental group

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.

Treatment:

Drug: Pimodivir

Part B: Group 4: Mild hepatic function

Experimental group

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.

Treatment:

Drug: Pimodivir