Study of Pharmacokinetic Interaction Between Kaletra® (LPV/r) and BILR 355 BS Plus Ritonavir in Healthy Subjects

NCT02256826 | Completed Phase 1

• 1 other identifier: 1188.8
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine the pharmacokinetic effect of BILR 355 BS on Kaletra® and of Kaletra® on BILR 355 BS

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve of the analyte in plasma over one dosing interval (12 hours) at steady state (AUC0-12h,ss)

  Up to 12 h after the last drug administration of BILR 355

• Maximum measured concentration of the analyte in plasma at steady state over a dosing interval τ (Cmax,ss)

  Up to 96 h after the last drug administration of BILR 355

Secondary Outcomes (11)

• Apparent clearance of the analyte in plasma following extravascular administration at steady state (CL/F,ss)

  Up to 96 h after the last drug administration of BILR 355

• Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)

  Up to 96 h after the last drug administration of BILR 355

• Terminal half-life of the analyte in plasma at steady state (t1/2,ss)

  Up to 96 h after the last drug administration of BILR 355

• Apparent volume of distribution during the terminal phase λz at steady state following an extravascular dose (Vz/F,ss)

  Up to 96 h after the last drug administration of BILR 355

• Area under the plasma concentration time curve (0-12 hours) (AUC0-12h) for RTV

  Up to 12 h after RTV administration

Study Arms (2)

Group A

EXPERIMENTAL

Drug: BILR 355 BS; Drug: Ritonavir (RTV); Drug: Kaletra®

Group B

EXPERIMENTAL

Drug: BILR 355 BS; Drug: Ritonavir (RTV)

Interventions

BILR 355 BS DRUG

Group A; Group B

Ritonavir (RTV) DRUG

NORVIR®

Group A; Group B

Kaletra® DRUG

(lopinavir (LPV) and ritonavir (RTV))

Group A

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Age ≥18 and \<60 years
• BMI ≥18.5 and BMI ≤29.9 kg/m2
• Ability to give signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local regulations
• Current (symptomatic within the last 30 days) and medically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of gastrointestinal tract (except appendectomy)
• Currently active (symptomatic within the last 30 days) diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life (\>24 hours) within one month prior to administration of study drug or during the trial (review with clinical monitor if questionable)
• Use of drugs within 10 days prior to administration or during the trial, which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation (review with clinical monitor if questionable)
• Participation in another trial with an investigational drug within one month prior to administration or during the trial
• Current smoker
• Alcohol (more than 60 g/day) or drug abuse (positive urine test for illicit prescription or non-prescription drugs or drugs of abuse)
• Recent blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
• Excessive physical activities (within 1 week prior to study drug administration or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Ritonavir; lopinavir-ritonavir drug combination

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 6, 2014
• Study Start: April 1, 2005
• Primary Completion: June 1, 2005
• Last Updated: October 6, 2014

Record last verified: 2014-10