Clinical trial NCT05155007: A Study in Healthy Adult Participants to Assess the Effects of Ciclosporin Administration on Rilematovir
Official title: A Phase 1, Open-label Study in Healthy Adult Participants to Assess the Effects of Ciclosporin Administration on the Single-dose Pharmacokinetics of Rilematovir
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-12-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Treatment A and Treatment C: Maximum Observed Plasma Analyte Concentration (Cmax) of Rilematovir
timeFrame: Pre-dose up to 24 hours
measure: Treatment A and Treatment C: The Actual Sampling Time to Reach the Maximum Observed Plasma Analyte Concentration (Tmax) of Rilematovir
timeFrame: Pre-dose up to 24 hours
measure: Treatment A and Treatment C: Apparent Terminal Elimination Half-life (T1/2) of Rilematovir
timeFrame: Pre-dose up to 96 hours
measure: 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
timeFrame: Pre-dose up to 96 hours
measure: 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
timeFrame: Pre-dose up to 96 hours
measure: Treatment A and Treatment C: Total Apparent Oral Clearance (CL/F) of Rilematovir
timeFrame: Pre-dose up to 96 hours
Secondary outcomes:
measure: Treatment B and Treatment C: Maximum Observed Whole Blood Analyte Concentration (Cmax) of Ciclosporin
timeFrame: Pre-dose up to 24 hours
measure: Treatment B and Treatment C: The Actual Sampling Time to Reach the Maximum Observed Whole Blood Analyte Concentration (Tmax) of Ciclosporin
timeFrame: Pre-dose up to 24 hours
measure: Treatment B and Treatment C: Apparent Terminal Elimination Half-life (T1/2) of Ciclosporin
timeFrame: Pre-dose up to 96 hours
measure: 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
timeFrame: Pre-dose up to 96 hours
measure: 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
timeFrame: Pre-dose up to 96 hours
measure: Treatment B and Treatment C: Total Apparent Oral Clearance (CL/F) of Ciclosporin
timeFrame: Pre-dose up to 96 hours
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: Up to Week 12
measure: Percentage of Participants with Abnormalities in Electrocardiogram (ECG)
timeFrame: Up to Week 12
measure: Percentage of Participants with Abnormalities in Physical Examination
timeFrame: Up to Week 12
measure: Percentage of Participants with Abnormalities in Vital Signs
timeFrame: Up to Week 12
measure: Percentage of Participants with Abnormalities in Clinical Laboratory Tests
timeFrame: Up to Week 12
Other outcomes:
Locations:
city: Merksem
country: Belgium
facility: Clinical Pharmacology Unit
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: