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Completed

NCT Number: NCT02259868

Study of New Tablet Formulations and Suspension Formulation Compared to Current (1B) Formulation of BILR 355 BS in Healthy Male Volunteer Subjects

1. To investigate the relative bioavailability (BA) of improved tablet formulation candidates to determine which formulation will be developed for use in late Phase II and Phase III clinical trials 2. To investigate the relative BA of the pediatric suspension, compared to the current 1B formulation 3. To investigate the bioequivalence (BE) of BILR 355 BS in two tablet strengths; three 25mg tablets vs. one 75 mg tablet, current 1B formulation

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy HIV negative adult male volunteers
  • Age ≥18 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

  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Surgery of gastrointestinal tract (except appendectomy)
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  • History of relevant orthostatic hypotension, fainting spells or blackouts
  • Chronic or relevant acute infections
  • 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 at least one month prior to study drug administration and during the trial
  • Use of drugs within 10 days prior to administration or during the trial which might reasonably influence the results of the trial
  • Participation in another trial with an investigational drug within two months prior to administration or during the trial
  • Current smoker
  • Alcohol abuse (more than 60 g/day)
  • Drug abuse (positive urine test for illicit prescription or non-prescription drugs or drugs of abuse).
  • Blood donation (more than 100 mL within four weeks prior to study drug administration or during the trial)
  • Excessive physical activities (within one week prior to study drug administration or during the trial)
  • Any laboratory value outside the 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
  • Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B surface antigen, or hepatitis C antibody positive

Treatment and study plan

BILR 355 BS /1B, current low dose formulation

Drug

BILR 355 BS /1B, current high dose formulation

Drug

BILR 355 BS - Jet Milled (JM) + Sodium Dodecyl Sulfate (SDS) formulation

Drug

BILR 355 BS - Hammer Milled (HM) + Sodium Dodecyl Sulfate (SDS) formulation

Drug

BILR 355 BS - Suspension low dose

Drug

BILR 355 BS - Suspension high dose

Drug

Ritonavir

Drug

Primary outcomes

  1. AUC0-∞ (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    Time frame: Up to 96 hours after drug administration

  2. Cmax (maximum measured concentration of analyte in plasma)

    Time frame: Up to 96 hours after drug administration

Secondary outcomes

  1. AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)

    Time frame: Up to 96 hours after drug administration

  2. tmax (time from dosing to the maximum concentration of the analyte in plasma)

    Time frame: Up to 96 hours after drug administration

  3. λz (terminal rate constant in plasma)

    Time frame: Up to 96 hours after drug administration

  4. t1/2 (terminal half-life of the analyte in plasma)

    Time frame: Up to 96 hours after drug administration

  5. MRTpo (mean residence time of the analyte in the body after po administration)

    Time frame: Up to 96 hours after drug administration

  6. CL/F (apparent clearance of the analyte in the plasma after extravascular administration)

    Time frame: Up to 96 hours after drug administration

  7. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)

    Time frame: Up to 96 hours after drug administration

  8. Number of participants with clinically significant changes in vital signs

    Time frame: Up to day 43 after first drug administration

  9. Number of participants with abnormal changes in clinical laboratory parameters

    Time frame: Up to day 43 after first drug administration

  10. Number of participants with Adverse Events

    Time frame: Up to day 43 after first drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Randomized Single Dose Multiple Crossover Relative Bioavailability Trial of New Tablet Formulations and Suspension Formulation Compared to Current (1B) Formulation of BILR 355 BS in Healthy Male Volunteer Subjects

Important dates

Study start
2005
Primary completion
2005
First posted
Oct 9, 2014
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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