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

NCT ID: NCT02182401

Last Updated: 2014-07-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BI 207127 NA

fixed sequence

Group Type: EXPERIMENTAL

BI 207127 NA

Intervention Type: DRUG

Days 3-8 and days 25-30

BI 201335 NA

Intervention Type: DRUG

Days 15-30

Midazolam

Intervention Type: DRUG

Days 1, 7, 23 and 29

Tolbutamide

Intervention Type: DRUG

Days 1, 7, 23 and 29

Interventions

BI 207127 NA

Days 3-8 and days 25-30

Intervention Type: DRUG

BI 201335 NA

Days 15-30

Intervention Type: DRUG

Midazolam

Days 1, 7, 23 and 29

Intervention Type: DRUG

Tolbutamide

Days 1, 7, 23 and 29

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1241.18

Identifier Type: -

Identifier Source: org_study_id