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Completed

NCT Number: NCT05155007

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

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rilematovir

Drug

Rilematovir will be administered orally as per assigned treatment sequence.

Other names: JNJ-53718678

Ciclosporin

Drug

Ciclosporin will be administered orally as per assigned treatment sequence.

Primary outcomes

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

    Time frame: Pre-dose up to 24 hours

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

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

    Time frame: Pre-dose up to 24 hours

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

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

    Time frame: Pre-dose up to 96 hours

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

  4. 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

    Time frame: Pre-dose up to 96 hours

    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.

  5. 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

    Time frame: Pre-dose up to 96 hours

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

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

    Time frame: Pre-dose up to 96 hours

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

Secondary outcomes

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

    Time frame: Pre-dose up to 24 hours

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

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

    Time frame: Pre-dose up to 24 hours

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

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

    Time frame: Pre-dose up to 96 hours

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

  4. 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

    Time frame: Pre-dose up to 96 hours

    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.

  5. 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

    Time frame: Pre-dose up to 96 hours

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

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

    Time frame: Pre-dose up to 96 hours

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

  7. Percentage of Participants with Adverse Events (AEs)

    Time frame: Up to Week 12

    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.

  8. Percentage of Participants with Abnormalities in Electrocardiogram (ECG)

    Time frame: Up to Week 12

    Percentage of participants with abnormalities in ECG will be reported.

  9. Percentage of Participants with Abnormalities in Physical Examination

    Time frame: Up to Week 12

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

  10. Percentage of Participants with Abnormalities in Vital Signs

    Time frame: Up to Week 12

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

  11. Percentage of Participants with Abnormalities in Clinical Laboratory Tests

    Time frame: Up to Week 12

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

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 13, 2021
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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