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Trial record 7 of 50 for:    BI 201335 OR faldaprevir

Drug Drug Interaction of BI 201335 and Tenofovir

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ClinicalTrials.gov Identifier: NCT01340196
Recruitment Status : Completed
First Posted : April 22, 2011
Results First Posted : July 31, 2015
Last Update Posted : July 31, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE April 20, 2011
First Posted Date  ICMJE April 22, 2011
Results First Submitted Date  ICMJE July 3, 2015
Results First Posted Date  ICMJE July 31, 2015
Last Update Posted Date July 31, 2015
Study Start Date  ICMJE April 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2015)
  • Steady-state Pharmacokinetics of AUC0-24 of Tenofovir on Day 7 and on Day 15 [ Time Frame: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 ]
    Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-24 hours, at steady state.
  • Steady-state Pharmacokinetics of Cmax of Tenofovir on Day 7 and on Day 15 [ Time Frame: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00. 192:00 hours on day 15 ]
    Maximum measured concentration of analyte in plasma (Cmax), at steady state.
  • Steady-state Pharmacokinetics of C24hr of Tenofovir on Day 7 and on Day 15 [ Time Frame: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 ]
    Measured concentration of the analyte in plasma at 24 h (C24hr) after dosing, at steady state.
  • Steady-state Pharmacokinetics of AUC0-12 of Faldaprevir on Day 15 and on Day 22 [ Time Frame: 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22 ]
    Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-12 hours, at steady state.
  • Steady-state Pharmacokinetics of Cmax of Faldaprevir on Day 15 and Day 22 [ Time Frame: 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22 ]
    Maximum measured concentration of analyte in plasma (Cmax), at steady state.
  • Steady-state Pharmacokinetics of C12hr of Faldaprevir on Day 15 and on Day 22 [ Time Frame: 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22 ]
    Measured concentration of the analyte in plasma at 12 h (C12hr) after dosing, at steady state.
Original Primary Outcome Measures  ICMJE
 (submitted: April 21, 2011)
  • Comparison of steady-state pharmacokinetics of AUC0-24 of tenofovir on Day 7 with Day 15 [ Time Frame: 2 weeks ]
  • Comparison steady-state pharmacokinetics of AUC0-12 of BI 201335 on Day 15 and on Day 22. [ Time Frame: 2 weeks ]
  • Comparison of steady-state pharmacokinetics of Cmax of tenofovir on Day 7 with Day 15 [ Time Frame: 2 weeks ]
  • Comparison of steady-state pharmacokinetics of C24hr of tenofovir on Day 7 with Day 15 [ Time Frame: 2 weeks ]
  • Comparison of steady-state pharmacokinetics of Cmax of BI 201335 on Day 15 and Day22 [ Time Frame: 2 weeks ]
  • Comparison of steady-state pharmacokinetics of C12hr of BI 201335 on Day 15 and Day 22 [ Time Frame: 2 weeks ]
Change History Complete list of historical versions of study NCT01340196 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2015)
  • Number of Patients With Drug Related Adverse Events During the Trial [ Time Frame: From drug administration up to 32 days. ]
    Outcome data are the numbers of subjects with investigator defined drug-related AEs
  • Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Safety Laboratory Tests and 12-lead ECG [ Time Frame: From drug administration up to 32 days. ]
    Clinical relevant abnormalities for physical examination, vital signs, safety laboratory tests and 12-lead ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. Preferred term of relevant AE: Presyncope
Original Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2011)
  • Number of adverse events during the trial [ Time Frame: this endpoint has no specific timeframe ]
  • Intensity of adverse events during the trial [ Time Frame: this endpoint has no specific timeframe ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Drug Drug Interaction of BI 201335 and Tenofovir
Official Title  ICMJE Effect of Multiple Dosing With 240 mg BID BI 201335 on the Steady State Pharmacokinetics of 300mg QD Tenofovir and Effect of Multiple Dosing With 300mg QD Tenofovir on Steady State BI 201335 Pharmacokinetics in Healthy Male and Female Volunteers
Brief Summary The objective of this study is to evaluate the drug-drug interaction potential between BI 201335 and concomitantly administered tenofovir which is used in treatment regimens for HIV infection and/or Hepatitis B infection. Results of this study will serve as a basis for guidance of dose adjustments or other precautionary measures when BI201335 and tenofovir are coadministered.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE Drug: tenofovir/BI 201335
tenofovir medium dose once daily (qd) for first 15 days; BI 201335 medium dose twice daily (bid) on days 8 through 22 with last dose on morning of day 22
Study Arms  ICMJE Experimental: sequence 1
tenofovir medium dose once daily (qd) for first 15 days; BI 201335 medium dose twice daily (bid) on days 8 through day 22 (morning dose on day 22 only)
Intervention: Drug: tenofovir/BI 201335
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2011)
16
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Healthy males and female subjects and according to medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram and clinical laboratory tests; all with acceptable findings.
  2. Age =18 to =55 years
  3. Weighing at least 50 kg, and body mass index >=18.5 and BMI <=29.9 kg/m2 (Body Mass Index).
  4. Volunteers must not leave the research unit, during the entire length of the study and must be willing to comply with the protocol and complete all study-related activities.

Exclusion criteria:

  1. Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance, as assessed by the investigator.
  2. Active diseases of the gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, musculoskeletal, immunologic, rheumatologic, hormonal, neurological system, clinically relevant electrolyte disorders or bleeding disorders that require current medical treatment.
  3. Diseases of the central nervous system or psychiatric disorders.
  4. History of photosensitivity or recurrent rash.
  5. History of orthostatic hypotension, fainting spells or blackouts.
  6. Chronic or clinically relevant acute infections.
  7. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant.
  8. Intake of drugs with a long half-life >24:00 hours within at least one month or less than ten half lives of the respective drug before enrollment in the study (with the exception of hormonal contraceptives).
  9. Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment as nutraceuticals and herbal remedies that would interfere with either the absorption, distribution or metabolism of BI 201335 NA, or that prolong the QT/QTc interval.
  10. Use of any investigational drug within 30 days prior to enrollment; or the planned use of any investigational drug during the course of the current study.
  11. Smoking (>10 cigarettes or >3 cigars or >3 pipes/day)
  12. Inability to abstain from smoking more than 3 cigarettes/day during the period of dosing with study medication.
  13. Drug and alcohol abuse (>60g/day).
  14. Blood donation (more than 100 mL within four weeks prior to administration or during the trial).
  15. Excessive physical activities within one week prior to administration or during the trial.
  16. Any laboratory value outside the reference range that is of clinical relevance at screening, according to the judgment of the investigator, and in consultation with the clinical monitor.
  17. Known elevated liver enzymes in past with any compound (experimental or marketed).
  18. Concomitant administration of any food product known to alter P450 enzyme activity such as grapefruit juice, Seville oranges, St. John's Wort.
  19. Concomitant administration of oral contraceptives (subjects who stopped oral contraceptives at least 7 days prior to Day 1 may be included.
  20. Inadequate venous access.
  21. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTcF, or QTcB interval >450 ms).
  22. Infection with hepatitis B (HBV), or hepatitis C virus (HCV),
  23. Positive test for HIV-1 or HIV-2. For women of child bearing potential (WOCBP)
  24. Pregnancy or planning to become pregnant within 2 months of study completion
  25. Positive pregnancy test at screening visit
  26. No proof of sterilization, or not willing or unable to consistently use an acceptable method of double barrier contraception including IUD, or diaphragm with spermicidal cream/jelly and condoms for male partner, during and up to 3 months after completion/termination of the trial.
  27. Lactation period with active breastfeeding from time of screening to 30 days after end of trial visit.

    For male subjects

  28. No proof of sterilization, or not willing or unable to consistently use an acceptable method of double barrier contraception including a condom each time and female partner of child bearing potential consistently uses oral birth control pills, or an IUD, or a diaphragm with spermicidal cream/jelly). Male subjects must not father a child from administration of the first dose and up to 3 months after the last dose of study medication.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01340196
Other Study ID Numbers  ICMJE 1220.50
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP