Relative Bioavailability of Two Newly Developed Tablet Formulations (TF2 and iFF)Compared to BI 1060469 TF1 Formulation, Following Oral Administration (Low and High Dose)in Healthy Female Subjects

Relative Bioavailability of Two Newly Developed Tablet Formulations (TF2 and iFF) Compared to BI 1060469 TF1 Formulation, Following Oral Administration (Low and High Dose) in Healthy Female Subjects (an Open-label, Randomised, Single-dose, Three-period, Three-sequence Crossover Study at Two Different Dose Strengths)

The primary objective is to investigate the relative bioavailability of two newly developed tablet formulations of BI 1060469 vs BI 1060469 TF1 formulation. The secondary objective is the comparison of several pharmacokinetic parameters between the treatments.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 1060469, iFF, Test; Drug: BI 1060469, TF1, Reference; Drug: BI 1060469, TF2, Test

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Biberach, Germany
    • 1333.4.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion criteria:

• Healthy female subjects according to the investigator¿s assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
• Age of 18 to 50 years (incl.)
• BMI of 18.5 to 29.9 kg/m2 (incl.)
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria:

• Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm at screening
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease judged as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• Chronic or relevant acute infections
• History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
• Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10 halflives of the respective drug prior to administration of trial medication
• Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial or that might prolong the QT/QTc interval
• Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication
• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
• Inability to refrain from smoking on specified trial days
• Alcohol abuse (consumption of more than 20 g per day)
• Drug abuse or positive drug screening
• Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
• Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
• Inability to comply with dietary regimen of trial site
• A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening
• A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
• Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
• Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion
• Lactation period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3 BI 1060469 low dose; TF2 followed by iFF followed by TF1	Drug: BI 1060469, iFF, Test; Drug: BI 1060469, TF1, Reference; Drug: BI 1060469, TF2, Test
Experimental: 1 BI 1060469 high dose; TF1 followed by TF2 followed by iFF	Drug: BI 1060469, iFF, Test; Drug: BI 1060469, TF1, Reference; Drug: BI 1060469, TF2, Test
Experimental: 2 BI 1060469 high dose; iFF followed by TF1 followed by TF2	Drug: BI 1060469, iFF, Test; Drug: BI 1060469, TF1, Reference; Drug: BI 1060469, TF2, Test
Experimental: 3 BI 1060469 high dose; TF2 followed by iFF followed by TF1	Drug: BI 1060469, iFF, Test; Drug: BI 1060469, TF1, Reference; Drug: BI 1060469, TF2, Test
Experimental: 1 BI 1060469 low dose; TF1 followed by TF2 followed by iFF	Drug: BI 1060469, iFF, Test; Drug: BI 1060469, TF1, Reference; Drug: BI 1060469, TF2, Test
Experimental: 2 BI 1060469 low dose; iFF followed by TF1 followed by TF2	Drug: BI 1060469, iFF, Test; Drug: BI 1060469, TF1, Reference; Drug: BI 1060469, TF2, Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)	up to 72 h
Cmax (maximum measured concentration of the analyte in plasma)	up to 72 h

Secondary Outcome Measures

Outcome Measure	Time Frame
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	up to 72 h

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: May 6, 2015
• First Submitted That Met QC Criteria: May 6, 2015
• First Posted (Estimate): May 8, 2015

Study Record Updates

• Last Update Posted (Estimate): September 24, 2015
• Last Update Submitted That Met QC Criteria: September 23, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 1333.4; 2014-005507-24 (EudraCT Number: EudraCT)