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Trial record 40 of 50 for:    BI 201335 OR faldaprevir

Multiple Doses of BI 207127 NA, BI 201335 NA Followed by the Combination of BI 207127 NA and BI 201335 NA in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02182401
Recruitment Status : Terminated
First Posted : July 8, 2014
Last Update Posted : July 18, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to investigate the pharmacokinetic drug-drug interaction potential of BI 207127 NA and BI 201335 NA on each other at steady-state and to quantify the effect of BI 207127 NA, and BI 207127 NA combined with BI 201335 NA, on the activity of CYP 2C9 and CYP 3A4 using the probe substrates tolbutamide (CYP 2C9) and midazolam (CYP 3A4).

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 207127 NA Drug: BI 201335 NA Drug: Midazolam Drug: Tolbutamide Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Fixed Sequence Phase I Study in Healthy Male Volunteers to Assess Sequentially the Effects of Multiple Doses of BI 207127 NA, BI 201335 NA Followed by the Combination of BI 207127 NA and BI 201335 NA, on the Single Dose Pharmacokinetics of Midazolam and Tolbutamide and on the Systemic Exposure of BI 207127 NA and BI 201335 NA
Study Start Date : July 2009
Actual Primary Completion Date : August 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BI 207127 NA
fixed sequence
Drug: BI 207127 NA
Days 3-8 and days 25-30

Drug: BI 201335 NA
Days 15-30

Drug: Midazolam
Days 1, 7, 23 and 29

Drug: Tolbutamide
Days 1, 7, 23 and 29




Primary Outcome Measures :
  1. Steady-state Cmax (Maximum measured concentration of the analyte in plasma) [ Time Frame: up to day 31 ]
  2. Steady-state AUC (Area under concentration-time curve) [ Time Frame: up to day 31 ]

Secondary Outcome Measures :
  1. Cmax for several time points [ Time Frame: up to day 31 ]
  2. Tmax (Time from dosing to the maximum measured concentration of the analyte in plasma) [ Time Frame: up to day 31 ]
  3. Cx for several time points [ Time Frame: up to day 31 ]
  4. AUC for several time points [ Time Frame: up to day 31 ]
  5. CL/F (Total apparent clearance of the analyte in plasma following extravascular administration) for several time points [ Time Frame: up to day 31 ]
  6. V/F (Apparent volume of distribution during following an extravascular dose) for several time points [ Time Frame: up to day 31 ]
  7. t1/2 (Terminal half-life of the analyte in plasma) [ Time Frame: up to day 31 ]
  8. Cavg0-24 [ Time Frame: up to day 31 ]
  9. Ratio for Cmax,Met at several time points [ Time Frame: up to day 31 ]
  10. Ratio for AUC at several time points [ Time Frame: up to day 31 ]
  11. Tlast,N [ Time Frame: up to day 31 ]
  12. Ae (amount of analyte eliminated in urine for different time points) [ Time Frame: up to day 29 ]
  13. CLR (renal clearance of the analyte for different time points) [ Time Frame: up to day 29 ]
  14. fe (fraction of analyte eliminated in urine for different time points) [ Time Frame: up to day 29 ]
  15. Number of patients with adverse events [ Time Frame: up to 66 days ]
  16. Assessment of tolerability on a 4-pointe scale by investigator [ Time Frame: within 14 days after last drug administration ]


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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males (caucasian)
  • Age ranging ≥ 21 and ≤ 50 years
  • Body mass index (BMI) ≥ 19 and ≤ 29.9 kg/m2
  • Willing to complete all study-related activities
  • Volunteers give their written informed consent prior to admission to the study

Exclusion criteria:

  • Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological 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 to the trial as judged by the investigator
  • 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 enrolment in the study or during the study
  • Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the trial or during the trial
  • vulnerable subjects (that is persons kept in detention)
  • exclusion of contraindications or hypersensitivity to midazolam and / or tolbutamide
  • Participation in another trial with an investigational drug (within two months prior to administration or during the trial)
  • Smoker (> 10 cigarettes or > 3 cigars of > 3 pipes/day)
  • Inability to refrain from smoking on trial days
  • Alcohol abuse (> 60 g/day)
  • Drug abuse
  • Blood donation (> 100 mL within four weeks prior to administration or during the trial)
  • Any laboratory value outside the reference range if indicative of underlying disease or poor health
  • Excessive physical activities within the last week before the trial or during the trial
  • Hypersensitivity to treatment medication and/or related drugs of these classes
  • A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTcF, or QTcB interval >450 ms)
  • Homozygous carriers of the UGT1A1 (uridine diphosphate glucuronosyltransferase 1A1) enzyme polymorphism *28 and *60

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02182401     History of Changes
Other Study ID Numbers: 1241.18
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 18, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Tolbutamide
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents