A Pilot study platform to investigate the pharmacodynamics on QT-prolongation and pharmacokinetics after multiple dose administration of potential combination treatments for COVID-19 in healthy volunteers

Medizinische Universität Wien; Universitätsklinik für Klinische Pharmakologie0 sites16 target enrollmentJuly 15, 2020

DrugsKALETRA - Filmtabletten 200 mg/50 mg Ribavirin-ratiopharm® 200 mg Filmtabletten

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Medizinische Universität Wien; Universitätsklinik für Klinische Pharmakologie
Enrollment: 16
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

July 15, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Medizinische Universität Wien; Universitätsklinik für Klinische Pharmakologie

Eligibility Criteria

Inclusion Criteria

•Age: between \=18 and \= 59 years old, has a body weight of at least 50 kg and has a body mass index (BMI) of 18 to 32 kg/m², inclusive
•Ability to comprehend the full nature and purpose of the study, including possible risks.
•Physical examination and laboratory analysis: no presence of clinically relevant abnormal findings or values which the investigator considers may interfere with the objectives of the present study.
•The female subject agrees to sexual abstinence, or is surgically sterile, postmenopausal (defined as at least 2 years at Screening without menses), or using a medically acceptable double barrier method (e.g. spermicide and diaphragm, or spermicide and condom) to prevent pregnancy and agrees to continue using this method from Screening until 3 weeks after the follow\-up visit at the end of the study; and is not lactating or pregnant as documented by negative pregnancy tests at Screening and day 1
•The male subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method from Screening until 3 weeks after the follow\-up visit at the end of the study
•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 16
•F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

•Age:\<18 years old
•Unwillingness to sign the informed consent
•The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death of a close relative at a young age due to possible or probable cardiac causes)
•The subject has a history of pancreatitis
•The subject has a positive result for hepatitis C antibodies, hepatitis B surface antigen at Screening or is known to be positive for human immunodeficiency virus (HIV) (Virology results not older than 6 months prior to screening are acceptable)
•The subject has a known or suspected allergy to any of the components of the trial products including ribavirin or lopinavir/ritonavir or a history of multiple and/or severe allergies to drugs or foods (as judged by the investigator), or a history of severe anaphylactic reactions\- \- The subject is a smoker (regular use of tobacco or nicotine containing products) within 1 month prior to screening
•The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to Day 1, or over\-the\-counter medications within 1 week prior to Day 1, with the exception of paracetamol up to 1 g/day
•The subject has a recent history (within the last 2 years) of drug or alcohol abuse, as defined by the investigator, or a positive drug and/or alcohol screen
•Inability to comprehend the full nature and purpose of the study