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

NCT02182401 | Terminated Phase 1

• 1 other identifier: 1241.18
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Steady-state Cmax (Maximum measured concentration of the analyte in plasma)

  up to day 31

• Steady-state AUC (Area under concentration-time curve)

  up to day 31

Secondary Outcomes (16)

• Cmax for several time points

  up to day 31

• Tmax (Time from dosing to the maximum measured concentration of the analyte in plasma)

  up to day 31

• Cx for several time points

  up to day 31

• AUC for several time points

  up to day 31

• CL/F (Total apparent clearance of the analyte in plasma following extravascular administration) for several time points

  up to day 31

Study Arms (1)

BI 207127 NA

EXPERIMENTAL

fixed sequence

Drug: BI 207127 NA; Drug: BI 201335 NA; Drug: Midazolam; Drug: Tolbutamide

Interventions

BI 207127 NA DRUG

Days 3-8 and days 25-30

BI 207127 NA

BI 201335 NA DRUG

Days 15-30

BI 207127 NA

Midazolam DRUG

Days 1, 7, 23 and 29

BI 207127 NA

Tolbutamide DRUG

Days 1, 7, 23 and 29

BI 207127 NA

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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
• 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)
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Midazolam; Tolbutamide

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfonylurea Compounds; Urea; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 8, 2014
• Study Start: July 1, 2009
• Primary Completion: August 1, 2009
• Last Updated: July 18, 2014

Record last verified: 2014-07