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

July 17, 2014 updated by: Boehringer Ingelheim

Relative Bioavailability of BI 207127 Trial Formulation II Prototypes Versus BI 207127 Trial Formulation I Administered Orally as Tablet in Single Doses of 800 mg to Healthy Volunteers, and Evaluation of the Effect of Food on the Bioavailability of a Selected Prototype (an Open-label, Two-stage, Within Parts Randomised Six-way and Two-way Crossover Phase I Study)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Excessive physical activities (within one week prior to first administration of the trial drug of the trial drug or during the trial)
  • Any laboratory value outside the reference range that is of clinical relevance
  • Inability to comply with dietary regimen of trial site
  • A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 MS)
  • A history of additional risk factors for Torsade de Points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
  • History of photosensitivity or recurrent rash

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: BI 207127 NA (TF-I)
trial part 1: 800 mg BI 207127 NA Trial formulation I (TF-I)
Drug: BI 207127 NA (TF-I)
200 mg tablet
Experimental: BI 207127 NA (TF-II)
trial part 1: 800 mg BI 207127 NA Trial formulation II (TF-II)
Drug: BI 207127 NA (TF-II)
400 mg tablet
Experimental: BI 207127 NA delayed release
trial part 1: 800 mg BI 207127 NA TF-II, delayed release
Drug: BI 207127 NA delayed release
400 mg tablet
Experimental: BI 207127 NA extended release (10% HPMC)
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)
400 mg tablet
Experimental: BI 207127 NA extended release (15% PEO)
trial part 1: 800 mg BI 207127 NA TF-II, extended release (15% Polyethylene oxide (PEO))
Drug: BI 207127 NA extended release (15% PEO)
400 mg tablet
Experimental: BI 207127 NA extended release (20% HPMC)
trial part 1: 800 mg BI 207127 NA TF-II, extended release (20% HPMC)
Drug: BI 207127 NA extended release (20% HPMC)
400 mg tablet
Experimental: BI 207127 (TF-II), fed
trial part 2
Drug: BI 207127 NA (TF-II)
400 mg tablet
Drug: BI 207127 NA delayed release
400 mg tablet
Drug: BI 207127 NA extended release (10% HPMC)
400 mg tablet
Drug: BI 207127 NA extended release (15% PEO)
400 mg tablet
Drug: BI 207127 NA extended release (20% HPMC)
400 mg tablet
Experimental: BI 207127 (TF-II), fasted
trial part 2
Drug: BI 207127 NA (TF-II)
400 mg tablet
Drug: BI 207127 NA delayed release
400 mg tablet
Drug: BI 207127 NA extended release (10% HPMC)
400 mg tablet
Drug: BI 207127 NA extended release (15% PEO)
400 mg tablet
Drug: BI 207127 NA extended release (20% HPMC)
400 mg tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for BI 207127
Time Frame: up to 48 hours after drug administration
up to 48 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma) for BI 207127
Time Frame: up to 48 hours after drug administration
up to 48 hours after drug administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from t1 to t2)
Time Frame: up to 24 hours after drug administration
up to 24 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time Frame: up to 48 hours after drug administration
up to 48 hours after drug administration
λz (terminal rate constant in plasma)
Time Frame: up to 48 hours after drug administration
up to 48 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time Frame: up to 48 hours after drug administration
up to 48 hours after drug administration
MRTpo (mean residence time of the analyte in the body after p.o. administration)
Time Frame: up to 48 hours after drug administration
up to 48 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time Frame: up to 48 hours after drug administration
up to 48 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time Frame: up to 48 hours after drug administration
up to 48 hours after drug administration
The fluctuation parameter Cmax/C12 for the ER (Extended release) formulations only
Time Frame: up to 48 hours after drug administration
up to 48 hours after drug administration
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Time Frame: up to 24 hours after drug administration in the food-effect part
up to 24 hours after drug administration in the food-effect part
fet1-t2 (fraction of analyte eliminated in urine compared to oral dose administered from time point t1 to time point t2)
Time Frame: up to 24 hours after drug administration in the food-effect part
up to 24 hours after drug administration in the food-effect part
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Time Frame: up to 24 hours after drug administration in the food-effect part
up to 24 hours after drug administration in the food-effect part
RCmax,Met (the ratio of Cmax of the metabolite, CD 6168 to Cmax of the parent compound, BI207127)
Time Frame: up to 48 hours after drug administration
up to 48 hours after drug administration
RAUC0-∞,Met (the ratio of AUC0-∞ of the metabolite, CD 6168 to AUC0-∞ of the parent compound, BI207127)
Time Frame: up to 48 hours after drug administration
up to 48 hours after drug administration
AUC0-∞ for CD 6168
Time Frame: up to 48 hours after drug administration
up to 48 hours after drug administration
Cmax for CD 6168
Time Frame: up to 48 hours after drug administration
up to 48 hours after drug administration
Measurement of protein binding in human plasma for BI 207127
Time Frame: up to 48 hours after drug administration in the food-effect part
up to 48 hours after drug administration in the food-effect part
Number of patients with adverse events
Time Frame: up to 9 weeks
up to 9 weeks
Assessment of tolerability on a 4-point scale
Time Frame: 48 h after each drug administration
48 h after each drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1241.9

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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