Pharmacokinetic Interaction Between TRUVADA™ and BILR 355 BS Plus Ritonavir in Healthy Volunteers

Study of Pharmacokinetic Interaction Between TRUVADA™ and BILR 355 BS Plus Ritonavir

Study to determine the pharmacokinetic effect of BILR 355 + ritonavir® on TRUVADA and TRUVADA on BILR 355

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Ritonavir; Drug: BILR 355 BS; Drug: TRUVADA

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and Females who meet the inclusion/exclusion criteria; females must not be pregnant or nursing, and must agree to use a double-barrier method of birth control (condoms or diaphragm, plus spermicide) throughout the trial (alone or in addition to other methods of birth control such as oral contraceptives)
• Age ≥18 and <60 years
• Body Mass Index (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

Exclusion Criteria:

• 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)
• Any laboratory value outside the normal reference range that is of clinical relevance at screening, according to the judgment of the investigator
• Inability to comply with dietary regimen required by the protocol
• Chronic or relevant acute infections
• Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B surface antigen, or hepatitis C antibody positive)
• HIV-1 infected as defined by a positive HIV ELISA test

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRUVADA with BILR 355 BS and ritonavir	Drug: Ritonavir; Drug: BILR 355 BS; Drug: TRUVADA
Active Comparator: BILR 355 BS in combination with ritonavir	Drug: Ritonavir; Drug: BILR 355 BS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve from 0 to 24 hours at steady state of the analyte in plasma (AUC0-24h,ss)	up to 24 h after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Apparent clearance of the analyte in plasma following extravascular administration at steady state (CL/F,ss)	up to day 18 after start of treatment
Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)	up to day 18 after start of treatment
Measured concentration of the analyte in plasma 24 hours post last dose at steady state (Cp24h, ss)	up to 24 h after treatment
Terminal half-life of of the analyte in plasma in the plasma at steady state (t1/2, ss)	up to day 18 after start of treatment
Apparent volume of distribution of of the analyte in plasma during the terminal phase λz at steady state following an extravascular dose (Vz/F,ss)	up to day 18 after start of treatment
Area under the concentration-time curve from 0 to 24 hours of ritonavir in plasma (AUC0-24h)	up to 24 h after treatment
Maximum measured concentration of ritonavir in plasma (Cmax)	up to 24 h after treatment
Number of subjects with clinically relevant changes in clinical laboratory tests	up to day 28 after start of treatment
Number of subjects with clinically relevant changes in vital signs (blood pressure, pulse rate)	up to day 28 after start of treatment
Number of subjects with adverse events	Up to 7 weeks

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): May 1, 2005

Study Registration Dates

• First Submitted: September 30, 2014
• First Submitted That Met QC Criteria: September 30, 2014
• First Posted (Estimate): October 1, 2014

Study Record Updates

• Last Update Posted (Estimate): October 1, 2014
• Last Update Submitted That Met QC Criteria: September 30, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
• Other Study ID Numbers: 1188.10