Drug Drug Interaction of BI 201335 and Tenofovir

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT01340196

Run by

Boehringer Ingelheim

People needed

16

Starts

2011-04-01

Last updated by the study team

2015-07-31

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 1220.50.0001 Boehringer Ingelheim Investigational Site — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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