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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05155007
• Other study ID #: CR109103
• Secondary ID: 2021-003801-2353
• Status: Completed
• Phase: Phase 1
• Start date: December 10, 2021
• Est. completion date: February 4, 2022

Study information

• Verified date: February 2022
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 4, 2022
• Est. primary completion date: February 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Rilematovir
Rilematovir will be administered orally as per assigned treatment sequence.
• Ciclosporin
Ciclosporin will be administered orally as per assigned treatment sequence.

Locations

Country	Name	City	State
Belgium	Clinical Pharmacology Unit	Merksem

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of Participants with Abnormalities in Electrocardiogram (ECG)	Percentage of participants with abnormalities in ECG will be reported.	Up to Week 12
Secondary	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
Secondary	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
Secondary	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

External Links

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