Respiratory Syncytial Virus (RSV) [Healthy Volunteers] MedDRA version: 20.0 Level: HLT Classification code 10038717 Term: Respiratory syncytial viral infections System Organ Class: 100000004862
Conditions
Interventions
Product Code: JNJ-53718678
Pharmaceutical Form: Powder and solvent for oral suspension
INN or Proposed INN: JNJ-53718678
Current Sponsor code: JNJ-53718678
Other descriptive name: rilematovir
Concentr
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives are to evaluate the PK of rilematovir after 125 mg qd or bid for 5 days coadministered with posaconazole at steady state and to evaluate the PK of rilematovir alone after administration of 250 mg bid for 8 days.;Secondary Objective: The secondary objective is to assess the safety and tolerability of rilematovir alone (250 mg bid for 8 days) and rilematovir (125 mg qd or bid for 5 days) in combination with posaconazole.;Primary end point(s): 1. PK of rilematovir after 125 mg qd or bid for 5 days coadministered with posaconazole at steady state 1a. Ctrough (Rilematovir) 1b. Ctrough (Posaconazole) 1c. Cmax (Rilematovir) 1d. Ctau (Rilematovir) 1e. tmax (Rilematovir) 1f. AUCtau,ss (Rilematovir) 2. PK of rilematovir alone after administration of 250 mg bid for 8 days. 2a. Cmax 2b. C12h 2c. tmax 2d. AUC12h 2e. AUCtau,ss 2f. Ctrough ;Timepoint(s) of evaluation of this end point: 1a. D3, D13 to D16 1b. D9 to D12 1c to 1f. D3 and D16 2a to 2c. D1 and D8 2d. D1 2e. D8 2f. D2, D3 and D5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Throughout the study ;Secondary end point(s): Safety and tolerability of rilematovir alone (250 mg bid for 8 days) and rilematovir (125 mg qd or bid for 5 days) in combination with posaconazole | — |
Countries
Belgium
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed