Bioavailability of Warfarin After Coadministration With Multiple Doses of BI 1356 Compared to the Bioavailability of Warfarin Alone in Healthy Male Volunteers

NCT02183389 | Completed Phase 1

• 1 other identifier: 1218.28
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate whether and to what extent BI 1356 affects pharmacokinetic and pharmacodynamic parameters of warfarin

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

  Up to 168 hours after start of study medication

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

  Up to 168 hours after start of study medication

Secondary Outcomes (17)

• Area under the concentration time curve (AUC) of the analyte in plasma at different time points

  Up to 168 hours after start of study medication

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

  Up to 168 hours after start of study medication

• Terminal rate constant in plasma (λz)

  Up to 168 hours after start of study medication

• Terminal half life of the analyte in plasma (t1/2)

  Up to 168 hours after start of study medication

• Mean residence time of the analyte in the body after p.o. administration (MRTpo)

  Up to 168 hours after start of study medication

Study Arms (2)

Treatment B: BI 1356 and Warfarin

EXPERIMENTAL

BI 1356 for 12 days combined with a single dose of warfarin on day 6

Drug: Warfarin; Drug: BI 1356

Treatment A: Warfarin

ACTIVE COMPARATOR

Warfarin as single dose

Drug: Warfarin

Interventions

Warfarin DRUG

Treatment A: Warfarin; Treatment B: BI 1356 and Warfarin

BI 1356 DRUG

Treatment B: BI 1356 and Warfarin

Eligibility Criteria

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

You may qualify if:

• Healthy males according to the following criteria:
• Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
• Age ≥ 18 and Age ≤ 50 years
• BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local legislation
• Homozygote wild-type carriers (\*1/\*1) of cytochrome P 450 (CYP) 2C9

You may not qualify if:

• Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 60 g/day)
• Drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Warfarin; Linagliptin

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Purines; Quinazolines

Study Design

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

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 8, 2014
• Study Start: May 1, 2008
• Primary Completion: October 1, 2008
• Last Updated: July 8, 2014

Record last verified: 2014-07