Drug Drug Interaction of BI 201335 and Tenofovir
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
tenofovir/BI 201335
Sponsored by

About this trial
This is an interventional treatment trial for HIV Infections
Eligibility Criteria
Inclusion criteria:
- 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.
- Age =18 to =55 years
- Weighing at least 50 kg, and body mass index >=18.5 and BMI <=29.9 kg/m2 (Body Mass Index).
- 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:
- 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.
- 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.
- Diseases of the central nervous system or psychiatric disorders.
- History of photosensitivity or recurrent rash.
- History of orthostatic hypotension, fainting spells or blackouts.
- Chronic or clinically relevant acute infections.
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant.
- 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).
- 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.
- 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.
- Smoking (>10 cigarettes or >3 cigars or >3 pipes/day)
- Inability to abstain from smoking more than 3 cigarettes/day during the period of dosing with study medication.
- Drug and alcohol abuse (>60g/day).
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial).
- Excessive physical activities within one week prior to 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, and in consultation with the clinical monitor.
- Known elevated liver enzymes in past with any compound (experimental or marketed).
- Concomitant administration of any food product known to alter P450 enzyme activity such as grapefruit juice, Seville oranges, St. John's Wort.
- Concomitant administration of oral contraceptives (subjects who stopped oral contraceptives at least 7 days prior to Day 1 may be included.
- Inadequate venous access.
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTcF, or QTcB interval >450 ms).
- Infection with hepatitis B (HBV), or hepatitis C virus (HCV),
- Positive test for HIV-1 or HIV-2. For women of child bearing potential (WOCBP)
- Pregnancy or planning to become pregnant within 2 months of study completion
- Positive pregnancy test at screening visit
- 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.
Lactation period with active breastfeeding from time of screening to 30 days after end of trial visit.
For male subjects
- 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.
Sites / Locations
- 1220.50.0001 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
sequence 1
Arm Description
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)
Outcomes
Primary Outcome Measures
Steady-state Pharmacokinetics of AUC0-24 of Tenofovir on Day 7 and 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
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
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
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
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
Measured concentration of the analyte in plasma at 12 h (C12hr) after dosing, at steady state.
Secondary Outcome Measures
Number of Patients With Drug Related Adverse Events During the Trial
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01340196
Brief Title
Drug Drug Interaction of BI 201335 and Tenofovir
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sequence 1
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
tenofovir/BI 201335
Intervention Description
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
Primary Outcome Measure Information:
Title
Steady-state Pharmacokinetics of AUC0-24 of Tenofovir on Day 7 and on Day 15
Description
Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-24 hours, at steady state.
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
Title
Steady-state Pharmacokinetics of Cmax of Tenofovir on Day 7 and on Day 15
Description
Maximum measured concentration of analyte in plasma (Cmax), at steady state.
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
Title
Steady-state Pharmacokinetics of C24hr of Tenofovir on Day 7 and on Day 15
Description
Measured concentration of the analyte in plasma at 24 h (C24hr) after dosing, at steady state.
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
Title
Steady-state Pharmacokinetics of AUC0-12 of Faldaprevir on Day 15 and on Day 22
Description
Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-12 hours, at steady state.
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
Title
Steady-state Pharmacokinetics of Cmax of Faldaprevir on Day 15 and Day 22
Description
Maximum measured concentration of analyte in plasma (Cmax), at steady state.
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
Title
Steady-state Pharmacokinetics of C12hr of Faldaprevir on Day 15 and on Day 22
Description
Measured concentration of the analyte in plasma at 12 h (C12hr) after dosing, at steady state.
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
Secondary Outcome Measure Information:
Title
Number of Patients With Drug Related Adverse Events During the Trial
Description
Outcome data are the numbers of subjects with investigator defined drug-related AEs
Time Frame
From drug administration up to 32 days.
Title
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Safety Laboratory Tests and 12-lead ECG
Description
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
Time Frame
From drug administration up to 32 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
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.
Age =18 to =55 years
Weighing at least 50 kg, and body mass index >=18.5 and BMI <=29.9 kg/m2 (Body Mass Index).
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:
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.
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.
Diseases of the central nervous system or psychiatric disorders.
History of photosensitivity or recurrent rash.
History of orthostatic hypotension, fainting spells or blackouts.
Chronic or clinically relevant acute infections.
History of allergy/hypersensitivity (including drug allergy) which is deemed relevant.
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).
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.
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.
Smoking (>10 cigarettes or >3 cigars or >3 pipes/day)
Inability to abstain from smoking more than 3 cigarettes/day during the period of dosing with study medication.
Drug and alcohol abuse (>60g/day).
Blood donation (more than 100 mL within four weeks prior to administration or during the trial).
Excessive physical activities within one week prior to 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, and in consultation with the clinical monitor.
Known elevated liver enzymes in past with any compound (experimental or marketed).
Concomitant administration of any food product known to alter P450 enzyme activity such as grapefruit juice, Seville oranges, St. John's Wort.
Concomitant administration of oral contraceptives (subjects who stopped oral contraceptives at least 7 days prior to Day 1 may be included.
Inadequate venous access.
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTcF, or QTcB interval >450 ms).
Infection with hepatitis B (HBV), or hepatitis C virus (HCV),
Positive test for HIV-1 or HIV-2. For women of child bearing potential (WOCBP)
Pregnancy or planning to become pregnant within 2 months of study completion
Positive pregnancy test at screening visit
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.
Lactation period with active breastfeeding from time of screening to 30 days after end of trial visit.
For male subjects
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1220.50.0001 Boehringer Ingelheim Investigational Site
City
Buffalo
State/Province
New York
Country
United States
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info
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Drug Drug Interaction of BI 201335 and Tenofovir
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