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

NCT02257021 | Completed Phase 1

• 1 other identifier: 1188.7
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve of tipranavir and BILR 355 BS in plasma over one dosing interval (12 hours) at steady state (AUC0-12h,ss)

  up to 18 days after start of treatment

• Maximum measured concentration of tipranavir and BILR 355 BS in plasma at steady state over a dosing interval τ (Cmax,ss)

  up to 18 days after start of treatment

Secondary Outcomes (11)

• Apparent clearance of BILR 355 BS, tipranavir and ritonavir in plasma following extravascular administration at steady state (CL/F,ss)

  up to 18 days after start of treatment

• Time from dosing to the maximum concentration of BILR 355 BS, tipranavir and ritonavir in plasma at steady state (tmax,ss)

  up to 18 days after start of treatment

• Terminal half-life of BILR 355 BS, tipranavir and ritonavir in plasma at steady state (t1/2,ss)

  up to 18 days after start of treatment

• Apparent volume of distribution of BILR 355 BS, tipranavir and ritonavir during the terminal phase λz at steady state following an extravascular dose (Vz/F,ss)

  up to 18 days after start of treatment

• Area under the concentration-time curve of ritonavir in plasma over one dosing interval (12 hours), (AUC0-12h)

  up to 18 days after start of treatment

Study Arms (2)

Tipranavir and high dose of ritonavir plus BILR 355 BS

EXPERIMENTAL

Drug: BILR 355 BS; Drug: Tipranavir; Drug: High dose of ritonavir

BILR 355 BS with low dose of ritonavir

EXPERIMENTAL

Drug: BILR 355 BS; Drug: Low dose of ritonavir

Interventions

BILR 355 BS DRUG

BILR 355 BS with low dose of ritonavir; Tipranavir and high dose of ritonavir plus BILR 355 BS

Tipranavir DRUG

Tipranavir and high dose of ritonavir plus BILR 355 BS

Low dose of ritonavir DRUG

BILR 355 BS with low dose of ritonavir

High dose of ritonavir DRUG

Tipranavir and high dose of ritonavir plus BILR 355 BS

Eligibility Criteria

• Age: 19 Years - 59 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

tipranavir; Ritonavir

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: February 1, 2005
• Primary Completion: May 1, 2005
• Last Updated: October 6, 2014

Record last verified: 2014-10