A study in healthy participants to find out how posaconazole interacts with 125mg rilematovir (taken once or twice a day), when they are given together and to find out how long rilematovir stays and acts in the body (pharmacokinetics) when given as 250mg twice a day

Phase 1

• Conditions: Respiratory Syncytial Virus (RSV) [Healthy Volunteers]; MedDRA version: 20.0Level: HLTClassification code 10038717Term: Respiratory syncytial viral infectionsSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-004050-30-BE
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-26
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Participants must satisfy the following criteria to be enrolled in the study:
1. Participant must be a man or woman 18 to 55 years of age, extremes included, at screening.
2. Participants must be healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination (including height and body weight measurement and skin examination), medical history, vital signs (body temperature, systolic blood pressure [SBP], diastolic blood pressure [DBP], pulse rate), and the results of blood biochemistry and hematology tests, and a urinalysis performed at screening and on Day -1. If there are abnormalities, with the exception of those described in the in- and exclusion criteria, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant’s source documents and initialed by the Investigator.
3. Participant must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study, including that he or she agrees to provide DNA samples for research, before starting any screening activities.
4. Female participants must have a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test at screening.
5. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies. At screening, a female participant must be:
a. Of non-childbearing potential defined as: premenarchal, postmenopausal, or permanently sterile.
b. Of childbearing potential practicing a highly effective method of contraception.
6. A female participant must agree not to donate eggs (ova, oocytes) for the purpose of assisted reproduction from Day 1 in the study until at least 30 days after last study drug administration.
7. A male participant
• who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception from the day of first study drug intake until 90 days after the last administration of study drug in the study, in conjunction with this female partner using a highly effective contraceptive.
OR must be heterosexually abstinent.
• who is sexually active with a woman who is pregnant must agree to use a condom from the day of first study drug intake until 90 days after the last administration of study drug in the study.
8. Participant must have a normal 12-lead ECGs consistent with normal cardiac conduction and function at screening and on Day -1, including:
-normal sinus rhythm (heart rate between 45 and 90 beats per minute, extremes included.
-QTcF interval =450 ms for men and =470 ms for women.
-QRS interval <110 ms.
-PR interval <200 ms.
-Electrocardiogram morphology consistent with healthy cardiac conduction and function.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any potential participant who meets any of the following criteria will be excluded from participating in the study.
1. Participant with a history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal dysfunction (calculated creatinine clearance below 60 mL/min at screening using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula), thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results.
2. Participants with one or more of the following laboratory abnormalities at screening or on Day-1, as defined by the WHO Toxicity Grading Scale:
• serum creatinine grade 1 or greater (=1.1 x upper limit of laboratory normal range [ULN]).
• lipase or total amylase grade 2 or greater (>1.5 x ULN).
• hemoglobin grade 1 or greater (=10.5 g/dL [10^5 g/L]).
• platelet count grade 1 or greater (=99.000/mm^3 [99x10^9/L]).
• absolute neutrophil count grade 1 or greater (=1500/mm^3 [1.5x10^9/L]).
• ALT or AST grade 1 or greater (=1.25 x ULN).
• total bilirubin grade 1 or greater (=1.1 x ULN).
• potassium grade 1 or greater (=3.4 mEq/L or =5.6 mEq/L).
• magnesium grade 1 or greater (=1.4 mEq/L).
• calcium grade 1 or greater (=10.6 mg/dL [corrected for albumin]).
• any other toxicity grade 2 or above, except for grade 2 elevations of triglycerides, low-density lipoprotein (LDL) cholesterol and/or cholesterol.
3. Participants with a past history of heart arrhythmias (extrasystole, tachycardia at rest), history of or risk factors for Torsade de Pointes syndrome (eg, hypokalemia, hypomagnesemia), or personal or family history of long QT syndrome or sudden cardiac death.
4. Presence of repetitive ventricular premature contractions (>10/min), second- or third degree heart block, complete or incomplete left bundle branch block, or complete right bundle branch block per the ECG result at screening. Presence of any of the above abnormalities should be confirmed by repeat ECG recording during screening.
5. Participants with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria.
6. Participant has known allergies, hypersensitivity, or intolerance to rilematovir or its excipients or to posaconazole or its excipients, or intolerance to other azole antifungal agents.
7. Participant has taken any disallowed therapies, Prestudy and Concomitant Therapy before the planned first dose of study drug.
8. Participants with lack of good/reasonable venous access.
9. Participants with a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, methadone, benzodiazepines, and hallucinogens) at screening and on Day -1.
10. Vulnerable participants (eg, incarcerated individuals).
11. Participant has donated blood or blood products or had substantial loss of blood (more than 500 mL) withi

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified