Relative Bioavailability of BI 207127 Trial Formulation II Prototypes Versus BI 207127 Trial Formulation I in Healthy Volunteers

NCT02182414 | Completed Phase 1

• 1 other identifier: 1241.9
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the relative bioavailability of 5 new 400 mg tablet formulations (trial formulation II prototypes) of BI 207127 compared to the current 200 mg BI 207127 tablet formulation (trial formulation I) in healthy male volunteers with the aim to identify the best formulation for further drug development (formulation finding part / trial part 1) and to investigate the effect of food on the relative bioavailability of the most promising one of these trial formulation II prototypes (food-effect part / trial part 2).

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) for BI 207127

  up to 48 hours after drug administration

• Cmax (maximum measured concentration of the analyte in plasma) for BI 207127

  up to 48 hours after drug administration

Secondary Outcomes (18)

• AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from t1 to t2)

  up to 24 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 p.o. administration)

  up to 48 hours after drug administration

Study Arms (8)

BI 207127 NA (TF-I)

ACTIVE COMPARATOR

trial part 1: 800 mg BI 207127 NA Trial formulation I (TF-I)

Drug: BI 207127 NA (TF-I)

BI 207127 NA (TF-II)

EXPERIMENTAL

trial part 1: 800 mg BI 207127 NA Trial formulation II (TF-II)

Drug: BI 207127 NA (TF-II)

BI 207127 NA delayed release

EXPERIMENTAL

trial part 1: 800 mg BI 207127 NA TF-II, delayed release

Drug: BI 207127 NA delayed release

BI 207127 NA extended release (10% HPMC)

EXPERIMENTAL

trial part 1: 800 mg BI 207127 NA TF-II, extended release (10% Hydroxypropyl methyl cellulose (HPMC))

Drug: BI 207127 NA extended release (10% HPMC)

BI 207127 NA extended release (15% PEO)

EXPERIMENTAL

trial part 1: 800 mg BI 207127 NA TF-II, extended release (15% Polyethylene oxide (PEO))

Drug: BI 207127 NA extended release (15% PEO)

BI 207127 NA extended release (20% HPMC)

EXPERIMENTAL

trial part 1: 800 mg BI 207127 NA TF-II, extended release (20% HPMC)

Drug: BI 207127 NA extended release (20% HPMC)

BI 207127 (TF-II), fed

EXPERIMENTAL

trial part 2

Drug: BI 207127 NA (TF-II); Drug: BI 207127 NA delayed release; Drug: BI 207127 NA extended release (10% HPMC); Drug: BI 207127 NA extended release (15% PEO); Drug: BI 207127 NA extended release (20% HPMC)

BI 207127 (TF-II), fasted

EXPERIMENTAL

trial part 2

Drug: BI 207127 NA (TF-II); Drug: BI 207127 NA delayed release; Drug: BI 207127 NA extended release (10% HPMC); Drug: BI 207127 NA extended release (15% PEO); Drug: BI 207127 NA extended release (20% HPMC)

Interventions

BI 207127 NA (TF-I) DRUG

200 mg tablet

BI 207127 NA (TF-I)

BI 207127 NA (TF-II) DRUG

400 mg tablet

BI 207127 (TF-II), fasted; BI 207127 (TF-II), fed; BI 207127 NA (TF-II)

BI 207127 NA delayed release DRUG

400 mg tablet

BI 207127 (TF-II), fasted; BI 207127 (TF-II), fed; BI 207127 NA delayed release

BI 207127 NA extended release (10% HPMC) DRUG

400 mg tablet

BI 207127 (TF-II), fasted; BI 207127 (TF-II), fed; BI 207127 NA extended release (10% HPMC)

BI 207127 NA extended release (15% PEO) DRUG

400 mg tablet

BI 207127 (TF-II), fasted; BI 207127 (TF-II), fed; BI 207127 NA extended release (15% PEO)

BI 207127 NA extended release (20% HPMC) DRUG

400 mg tablet

BI 207127 (TF-II), fasted; BI 207127 (TF-II), fed; BI 207127 NA extended release (20% HPMC)

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 a complete medical history, including a physical examination,vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
• Age 18 to 50 years, inclusive
• Body mass index 18.5 to 29.9 kg/m2, inclusive
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

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 prior to administration of the trial drug or during the trial
• Use of any drugs (including herbal preparations, vitamins and nutrient supplements) within 14 days prior to first administration of the trial drug or during the trial
• Participation in another trial with an investigational drug within two months prior to administration of the trial drug or during the trial
• Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
• Alcohol abuse (more than 40 g/day)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to first administration of the trial drug or during the trial)

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

Record last verified: 2014-07