A Phase 1, Open-label Study in Healthy Adult Participants to Assess the Effects of Multiple-dose Posaconazole on the Multiple-dose Administration of 125 mg Once-daily or Twice-daily Rilematovir and to Evaluate the Pharmacokinetics of 250 mg Twice-daily Rilematovir

Janssen-Cilag International NV0 sites45 target enrollmentNovember 26, 2020

DrugsPosaconazole Accord 100 mg gastro-resistant tablets

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Janssen-Cilag International NV
Enrollment: 45
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 26, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Janssen-Cilag International NV

Eligibility 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

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).