Healthy volunteers
Conditions
Interventions
Trade Name: KALETRA - Filmtabletten 200 mg/50 mg
Product Name: Kaletra
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LOPINAVIR
CAS Number: 192725-17-0
Concentration unit: mg milligram(s
Sponsors
Medizinische Universität Wien; Universitätsklinik für Klinische Pharmakologie
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the pharmacodynamics on QT-Prolongation of ribavirin with lopinavir/ritonavir • To assess the steady state pharmacokinetics of single substance and combined treatment of ribavirin with lopinavir/ritonavir ;Secondary Objective: • PK sample collection and ECG measurements • Safety and tolerability of the combination therapies ;Primary end point(s): Pharmacodynamic endpoint (at steady state): change from baseline in Fridericia-corrected QT interval (?QTcF) Pharmacokinetic endpoints (at steady state): Cmax , tmax , t/2, AUC0-n of each drug ;Timepoint(s) of evaluation of this end point: Data acquisition at defined timepoints before and during clinical phase Evaluation after completion of the clinical phase | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Adverse events;Timepoint(s) of evaluation of this end point: Data acquisition at defined timepoints during clinical phase Evaluation after completion of the clinical phase | — |
Countries
Austria
Contacts
Public ContactOffice Klinische Pharmakologie
Medizinische Universität Wien
Outcome results
None listed