A Study of Orally Administered Pimodivir in Adult Partici... | NCT03816631

NCT03816631

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2018-002817-36	EudraCT Number
63623872FLZ1013	Other Identifier	Janssen-Cilag International NV

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part A: Group 1: Severe hepatic function	Experimental	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
Part A and B: Group 2: Normal hepatic function	Experimental	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
Part B: Group 3: Moderate hepatic function	Experimental	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
Part B: Group 4: Mild hepatic function	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pimodivir	Drug	Participants will receive single oral dose of Pimodivir 600 mg (2*300 mg tablets) under fasted condition on Day 1.	Part A and B: Group 2: Normal hepatic function

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)
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)
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.](streamdown:incomplete-link)	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 Outcomes

Measure	Description	Time Frame
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

Eligibility Module

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](streamdown:incomplete-link)

Name	Affiliation	Role
Janssen-Cilag International NV Clinical Trial	Janssen-Cilag International NV	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
CRS Clinical Research Services Kiel GmbH		Kiel		24105	Germany
APEX GmbH

IPD Sharing Statement Module