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

A Phase 1, Open-label Study in Healthy Adult Participants to Assess the Effects of Ciclosporin Administration on the Single-dose Pharmacokinetics of Rilematovir

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Rilematovir; Drug: Ciclosporin

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Merksem, Belgium, 2170
    • Clinical Pharmacology Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Sequence ABC; Participants will receive a single oral dose of rilematovir (Treatment A) in Treatment Period 1, followed by a single oral dose of ciclosporin (Treatment B) in Treatment Period 2 and then single oral dose of ciclosporin plus single oral dose of rilematovir (Treatment C) in Treatment Period 3 on Day 1 of each Treatment Period under fasted conditions. Each treatment period will be separated by a washout period of at least 5 days and maximum 21 days between subsequent intakes of study intervention.	Drug: Rilematovir; Rilematovir will be administered orally as per assigned treatment sequence.; Other Names: JNJ-53718678; Drug: Ciclosporin; Ciclosporin will be administered orally as per assigned treatment sequence.
Experimental: Treatment Sequence BCA; Participants will receive Treatment B in Treatment Period 1, followed by Treatment C in Treatment Period 2 and then Treatment A in Treatment Period 3 on Day 1 of each Treatment Period under fasted conditions. Each treatment period will be separated by a washout period of at least 5 days and maximum 21 days between subsequent intakes of study intervention.	Drug: Rilematovir; Rilematovir will be administered orally as per assigned treatment sequence.; Other Names: JNJ-53718678; Drug: Ciclosporin; Ciclosporin will be administered orally as per assigned treatment sequence.
Experimental: Treatment Sequence CAB; Participants will receive Treatment C in Treatment Period 1, followed by Treatment A in Treatment Period 2 and then Treatment B in Treatment Period 3 on Day 1 of each Treatment Period under fasted conditions. Each treatment period will be separated by a washout period of at least 5 days and maximum 21 days between subsequent intakes of study intervention.	Drug: Rilematovir; Rilematovir will be administered orally as per assigned treatment sequence.; Other Names: JNJ-53718678; Drug: Ciclosporin; Ciclosporin will be administered orally as per assigned treatment sequence.
Experimental: Treatment Sequence ACB; Participants will receive Treatment A in Treatment Period 1, followed by Treatment C in Treatment Period 2 and then Treatment B in Treatment Period 3 on Day 1 of each Treatment Period under fasted conditions. Each treatment period will be separated by a washout period of at least 5 days and maximum 21 days between subsequent intakes of study intervention.	Drug: Rilematovir; Rilematovir will be administered orally as per assigned treatment sequence.; Other Names: JNJ-53718678; Drug: Ciclosporin; Ciclosporin will be administered orally as per assigned treatment sequence.
Experimental: Treatment Sequence BAC; Participants will receive Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2 and then Treatment C in Treatment Period 3 on Day 1 of each Treatment Period under fasted conditions. Each treatment period will be separated by a washout period of at least 5 days and maximum 21 days between subsequent intakes of study intervention.	Drug: Rilematovir; Rilematovir will be administered orally as per assigned treatment sequence.; Other Names: JNJ-53718678; Drug: Ciclosporin; Ciclosporin will be administered orally as per assigned treatment sequence.
Experimental: Treatment Sequence CBA; Participants will receive Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2 and then Treatment A in Treatment Period 3 on Day 1 of each Treatment Period under fasted conditions. Each treatment period will be separated by a washout period of at least 5 days and maximum 21 days between subsequent intakes of study intervention.	Drug: Rilematovir; Rilematovir will be administered orally as per assigned treatment sequence.; Other Names: JNJ-53718678; Drug: Ciclosporin; Ciclosporin will be administered orally as per assigned treatment sequence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment A and Treatment C: Maximum Observed Plasma Analyte Concentration (Cmax) of Rilematovir	Cmax is defined as maximum observed plasma analyte concentration of rilematovir.	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.	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.	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.	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.	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.	Pre-dose up to 96 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	Up to Week 12
Percentage of Participants with Abnormalities in Electrocardiogram (ECG)	Percentage of participants with abnormalities in ECG will be reported.	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.	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.	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.	Up to Week 12

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2021
• Primary Completion (Actual): February 4, 2022
• Study Completion (Actual): February 4, 2022

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Antifungal Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Dermatologic Agents; Calcineurin Inhibitors; Cyclosporine; Cyclosporins
• Other Study ID Numbers: CR109103; 2021-003801-23 (EudraCT Number); 53718678RSV1014 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes