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

• Register: ClinicalTrials.gov
• Last refreshed on: 6 October 2015
• Main ID: NCT02438696
• Date of registration: 06/05/2015
• Prospective Registration: No
• Primary sponsor: Boehringer Ingelheim
• Public title: 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
• Scientific title: 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)
• Date of first enrolment: May 2015
• Target sample size: 29
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02438696
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: BI 1060469, TF2, Test

Drug: BI 1060469, iFF, Test

Drug: BI 1060469, TF1, Reference

Primary Outcome(s)

Cmax (maximum measured concentration of the analyte in plasma) [Time Frame: up to 72 h]

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) [Time Frame: up to 72 h]

Secondary Outcome(s)

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

Secondary ID(s)

2014-005507-24

1333.4

Source(s) of Monetary Support

Please refer to primary and secondary sponsors