Pharmacokinetic Interaction Between Tipranavir and BILR 355 BS Plus Ritonavir in Healthy Male Volunteers

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Tipranavir

Drug: BILR 355 BS

Drug: Low dose of ritonavir

Drug: High dose of ritonavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT02257021

1188.7

Details and patient eligibility

About

To determine the effect of BILR 355/r on tipranavir/r pharmacokinetics and the effect of tipranavir/r on BILR 355 BS pharmacokinetics

Enrollment

34 patients

Sex

Male

Ages

19 to 59 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age ≥19 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

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 or smoked within the past 30 days
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 56 days 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