A Study in Healthy Adult Participants to Assess the Effects of Ciclosporin Administration on Rilematovir

Janssen Research & Development, LLC18 enrolled

Overview

The purpose of this study is to evaluate the pharmacokinetic (PK) of a single-dose of rilematovir co-administered with a single-dose of ciclosporin compared to a single-dose administration of rilematovir alone.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

RilematovirDRUG

Rilematovir will be administered orally as per assigned treatment sequence.

CiclosporinDRUG

Ciclosporin will be administered orally as per assigned treatment sequence.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Body weight not less than 50 kilograms (kg) and body mass index (BMI; weight kg/height\^2 \[meter {m\^2}\]) within the range 18.0 to 30.0 kilograms per meter square (kg/m\^2) (inclusive) * Female participants, except those that are of non-childbearing potential, must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and a negative urine pregnancy test on Day -1 of Treatment Period 1 * A female participant using hormonal contraceptives as a means of birth control (a stable treatment for at least 30 days prior to screening) must agree to continue use of the same hormonal contraceptives throughout the study and for 90 days after the end of last study treatment * Blood pressure (after the participant is supine for at least 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic * A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function, including: normal sinus rhythm (heart rate between 45 and 90 beats per minute, extremes included); QTc interval less than or equal to (\<=) 450 milliseconds (ms) for men, \<= 470 for women; QRS interval of less than (\<) 110 ms; PR interval \<= 200 ms; electrocardiogram morphology consistent with healthy cardiac conduction and function Exclusion Criteria: * Participants with abnormal values for alanine aminotransferase (ALT) and aspartate aminotransferase (AST) Grade 1 or greater (greater than \[\>\] 1.25\* upper limit of normal \[ULN\]) * Participants with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria * Known allergies, hypersensitivity, or intolerance to rilematovir or its excipients. Known allergies, hypersensitivity, or intolerance to ciclosporin or its excipients * Participant has received an experimental drug, vaccine 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 the first dose of the study intervention is scheduled * Participant has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening

Locations (1)

Clinical Pharmacology Unit

Merksem, Belgium

Outcomes

Primary Outcomes

Treatment A and Treatment C: Maximum Observed Plasma Analyte Concentration (Cmax) of Rilematovir

Cmax is defined as maximum observed plasma analyte concentration of rilematovir.

Time frame: Pre-dose up to 24 hours

Treatment A and Treatment C: The Actual Sampling Time to Reach the Maximum Observed Plasma Analyte Concentration (Tmax) of Rilematovir

Tmax is defined as the actual sampling time to reach the maximum observed plasma analyte concentration of rilematovir.

Time frame: Pre-dose up to 24 hours

Treatment A and Treatment C: Apparent Terminal Elimination Half-life (T1/2) of Rilematovir

T1/2 is defined as the apparent terminal elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve.

Time frame: Pre-dose up to 96 hours

Treatment A and Treatment C: Area Under the Plasma Analyte Concentration Versus Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC[0-last]) of Rilematovir

AUC(0-last) is defined as area under the plasma analyte concentration versus time curve from time zero to the time of the last measurable concentration of rilematovir.

Time frame: Pre-dose up to 96 hours

Treatment A and Treatment C: Area Under the Plasma Analyte Concentration Versus Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Rilematovir

AUC(0-infinity) is defined as area under the plasma analyte concentration versus time curve from time zero to infinite time of rilematovir.

Time frame: Pre-dose up to 96 hours

Treatment A and Treatment C: Total Apparent Oral Clearance (CL/F) of Rilematovir

CL/F is defined as total apparent oral clearance of rilematovir.

Time frame: Pre-dose up to 96 hours

Data from ClinicalTrials.gov

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Secondary Outcomes

Treatment B and Treatment C: Maximum Observed Whole Blood Analyte Concentration (Cmax) of Ciclosporin

Cmax is defined as maximum observed whole blood analyte concentration of ciclosporin.

Time frame: Pre-dose up to 24 hours

Treatment B and Treatment C: The Actual Sampling Time to Reach the Maximum Observed Whole Blood Analyte Concentration (Tmax) of Ciclosporin

Tmax is defined as the actual sampling time to reach the maximum observed whole blood analyte concentration of ciclosporin.

Time frame: Pre-dose up to 24 hours

Treatment B and Treatment C: Apparent Terminal Elimination Half-life (T1/2) of Ciclosporin

T1/2 is defined as apparent terminal elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve.

Time frame: Pre-dose up to 96 hours

Treatment B and Treatment C: Area Under the Whole Blood Analyte Concentration Versus Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC[0-last]) of Ciclosporin

AUC(0-last) is defined as area under the whole blood analyte concentration versus time curve from time zero to the time of the last measurable concentration of ciclosporin.

Time frame: Pre-dose up to 96 hours

Treatment B and Treatment C: Area Under the Whole Blood Analyte Concentration Versus Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Ciclosporin

AUC(0-infinity) is defined as area under the whole blood analyte concentration versus time curve from time Zero to infinite time of ciclosporin.

Time frame: Pre-dose up to 96 hours

Treatment B and Treatment C: Total Apparent Oral Clearance (CL/F) of Ciclosporin

CL/F is defined as total apparent oral clearance of ciclosporin.

Time frame: Pre-dose up to 96 hours

Percentage of Participants with Adverse Events (AEs)

An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.

Time frame: Up to Week 12

Percentage of Participants with Abnormalities in Electrocardiogram (ECG)

Percentage of participants with abnormalities in ECG will be reported.

Time frame: Up to Week 12

Percentage of Participants with Abnormalities in Physical Examination

Percentage of participants with abnormalities in physical examination (including height, body weight and examination of all body systems and dermatologic examinations) will be reported.

Time frame: Up to Week 12

Percentage of Participants with Abnormalities in Vital Signs

Percentage of participants with abnormalities in vital signs (including temperature \[tympanic\], pulse/heart rate, blood pressure \[systolic and diastolic\]) will be reported.

Time frame: Up to Week 12

Percentage of Participants with Abnormalities in Clinical Laboratory Tests

Percentage of participants with abnormalities in clinical laboratory tests (including serum chemistry, hematology and routine urinalysis) will be reported.

Time frame: Up to Week 12