Bioavailability of Four Oral Prototype Extended Release Formulations With BI 11634 in Healthy Male Volunteers

NCT02214953 | Completed Phase 1

• 1 other identifier: 1234.7
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the oral bioavailability and rate of absorption of four prototype extended-release (ER) formulations with BI 11634 (single doses) to immediate-release (IR) tablets in healthy male volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

  up to 48 hours after drug administraton

• Cmax (maximum measured concentration of analyte in plasma)

  up to 48 hours after drug administraton

Secondary Outcomes (15)

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)

  up to 48 hours after drug administration

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

  up to 48 hours after drug administration

• λz (terminal rate constant in plasma)

  up to 48 hours after drug administration

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

  up to 48 hours after drug administration

• MRTpo (mean residence time of the analyte in the body after oral administration)

  up to 48 hours after drug administration

Study Arms (5)

BI 11634 ER formulation A

EXPERIMENTAL

Drug: BI 11634 ER formulation A

BI 11634 ER formulation B

EXPERIMENTAL

Drug: BI 11634 ER formulation B

BI 11634 ER formulation M

EXPERIMENTAL

Drug: BI 11634 ER formulation M

BI 11634 ER formulation C

EXPERIMENTAL

Drug: BI 11634 ER formulation C

BI 11634 IR tablet

ACTIVE COMPARATOR

Drug: BI 11634 IR tablet

Interventions

BI 11634 ER formulation A DRUG

BI 11634 ER formulation A

BI 11634 ER formulation B DRUG

BI 11634 ER formulation B

BI 11634 ER formulation M DRUG

BI 11634 ER formulation M

BI 11634 ER formulation C DRUG

BI 11634 ER formulation C

BI 11634 IR tablet DRUG

BI 11634 IR tablet

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Caucasian males according to the following criteria, based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, clinical laboratory tests
• Age ≥21 and ≤45 years
• Haemoglobin within the normal ranges.
• Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local legislation

You may not qualify if:

• Relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Relevant surgery of gastrointestinal tract
• History of any bleeding disorder or acute blood coagulation defect, for the subject itself or any person of his family as far as known
• History of gastric ulcera and cholecystectomy
• Occult blood in faeces
• Relevant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Relevant chronic or 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 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 based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Use of acetylsalicylic acid or any other non-steroidal anti-inflammatory drugs (NSAID) within 2 weeks of study start until the end of study
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Alcohol abuse (more than 40 g/day)
• Drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

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

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 13, 2014
• Study Start: October 1, 2007
• Primary Completion: December 1, 2007
• Last Updated: August 13, 2014

Record last verified: 2014-08