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

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ClinicalTrials.gov Identifier: NCT02257021
Recruitment Status : Completed
First Posted : October 6, 2014
Last Update Posted : October 6, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Drug: BILR 355 BS Drug: Tipranavir Drug: Low dose of ritonavir Drug: High dose of ritonavir Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Pharmacokinetic Interaction Between Tipranavir and BILR 355 BS Plus Ritonavir
Study Start Date : February 2005
Actual Primary Completion Date : May 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tipranavir and high dose of ritonavir plus BILR 355 BS Drug: BILR 355 BS
Drug: Tipranavir
Drug: High dose of ritonavir
Experimental: BILR 355 BS with low dose of ritonavir Drug: BILR 355 BS
Drug: Low dose of ritonavir



Primary Outcome Measures :
  1. 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) [ Time Frame: up to 18 days after start of treatment ]
  2. Maximum measured concentration of tipranavir and BILR 355 BS in plasma at steady state over a dosing interval τ (Cmax,ss) [ Time Frame: up to 18 days after start of treatment ]

Secondary Outcome Measures :
  1. Apparent clearance of BILR 355 BS, tipranavir and ritonavir in plasma following extravascular administration at steady state (CL/F,ss) [ Time Frame: up to 18 days after start of treatment ]
  2. Time from dosing to the maximum concentration of BILR 355 BS, tipranavir and ritonavir in plasma at steady state (tmax,ss) [ Time Frame: up to 18 days after start of treatment ]
  3. Terminal half-life of BILR 355 BS, tipranavir and ritonavir in plasma at steady state (t1/2,ss) [ Time Frame: up to 18 days after start of treatment ]
  4. 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) [ Time Frame: up to 18 days after start of treatment ]
  5. Area under the concentration-time curve of ritonavir in plasma over one dosing interval (12 hours), (AUC0-12h) [ Time Frame: up to 18 days after start of treatment ]
  6. Maximum measured concentration of ritonavir in plasma at steady state over a dosing interval τ (Cmax,ss) [ Time Frame: up to 18 days after start of treatment ]
  7. Measured concentration of BILR 355 BS, tipranavir and ritonavir in plasma 12 hours post last dose at steady state (Cp12h,ss) [ Time Frame: up to 18 days after start of treatment ]
  8. Number of participants with clinically relevant changes in laboratory parameters [ Time Frame: up to 28 days after start of treatment ]
  9. Number of participants with clinically relevant changes in vital signs (blood pressure, pulse rate) [ Time Frame: up to 28 days after start of treatment ]
  10. Number of participants with clinically relevant changes in 12-lead ECG [ Time Frame: up to 14 days after start of treatment ]
  11. Number of participants with adverse events [ Time Frame: Up to 7 weeks ]


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Ages Eligible for Study:   19 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02257021     History of Changes
Other Study ID Numbers: 1188.7
First Posted: October 6, 2014    Key Record Dates
Last Update Posted: October 6, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Ritonavir
Tipranavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors