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

NCT ID: NCT02253901

Last Updated: 2014-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TRUVADA with BILR 355 BS and ritonavir

Group Type: EXPERIMENTAL

BILR 355 BS

Intervention Type: DRUG

Ritonavir

Intervention Type: DRUG

TRUVADA

Intervention Type: DRUG

BILR 355 BS in combination with ritonavir

Group Type: ACTIVE_COMPARATOR

BILR 355 BS

Intervention Type: DRUG

Ritonavir

Intervention Type: DRUG

Interventions

BILR 355 BS

Intervention Type: DRUG

Ritonavir

Intervention Type: DRUG

TRUVADA

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1188.10

Identifier Type: -

Identifier Source: org_study_id