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

NCT05155007 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR1091032021-003801-2353718678RSV1014
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (11)

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

  Pre-dose up to 24 hours

• Treatment B and Treatment C: Apparent Terminal Elimination Half-life (T1/2) 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 the Time of the Last Measurable Concentration (AUC[0-last]) 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

  Pre-dose up to 96 hours

Study Arms (6)

Treatment Sequence ABC

EXPERIMENTAL

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; Drug: Ciclosporin

Treatment Sequence BCA

EXPERIMENTAL

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; Drug: Ciclosporin

Treatment Sequence CAB

EXPERIMENTAL

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; Drug: Ciclosporin

Treatment Sequence ACB

EXPERIMENTAL

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; Drug: Ciclosporin

Treatment Sequence BAC

EXPERIMENTAL

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; Drug: Ciclosporin

Treatment Sequence CBA

EXPERIMENTAL

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; Drug: Ciclosporin

Interventions

Rilematovir DRUG

Rilematovir will be administered orally as per assigned treatment sequence.

Also known as: JNJ-53718678

Treatment Sequence ABC; Treatment Sequence ACB; Treatment Sequence BAC; Treatment Sequence BCA; Treatment Sequence CAB; Treatment Sequence CBA

Ciclosporin DRUG

Ciclosporin will be administered orally as per assigned treatment sequence.

Treatment Sequence ABC; Treatment Sequence ACB; Treatment Sequence BAC; Treatment Sequence BCA; Treatment Sequence CAB; Treatment Sequence CBA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Location

MeSH Terms

Interventions

JNJ-53718678; Cyclosporine

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 13, 2021
• Study Start: December 10, 2021
• Primary Completion: February 4, 2022
• Study Completion: February 4, 2022
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)