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

NCT02438696 | Completed Phase 1

• 2 other identifiers: 1333.42014-005507-24
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (6)

3 BI 1060469 low dose

EXPERIMENTAL

TF2 followed by iFF followed by TF1

Drug: BI 1060469, TF1, Reference; Drug: BI 1060469, TF2, Test; Drug: BI 1060469, iFF, Test

1 BI 1060469 high dose

EXPERIMENTAL

TF1 followed by TF2 followed by iFF

Drug: BI 1060469, iFF, Test; Drug: BI 1060469, TF1, Reference; Drug: BI 1060469, TF2, Test

2 BI 1060469 high dose

EXPERIMENTAL

iFF followed by TF1 followed by TF2

Drug: BI 1060469, iFF, Test; Drug: BI 1060469, TF2, Test; Drug: BI 1060469, TF1, Reference

3 BI 1060469 high dose

EXPERIMENTAL

TF2 followed by iFF followed by TF1

Drug: BI 1060469, TF2, Test; Drug: BI 1060469, iFF, Test; Drug: BI 1060469, TF1, Reference

1 BI 1060469 low dose

EXPERIMENTAL

TF1 followed by TF2 followed by iFF

Drug: BI 1060469, iFF, Test; Drug: BI 1060469, TF1, Reference; Drug: BI 1060469, TF2, Test

2 BI 1060469 low dose

EXPERIMENTAL

iFF followed by TF1 followed by TF2

Drug: BI 1060469, iFF, Test; Drug: BI 1060469, TF1, Reference; Drug: BI 1060469, TF2, Test

Interventions

BI 1060469, iFF, Test DRUG

2 BI 1060469 high dose

BI 1060469, TF1, Reference DRUG

3 BI 1060469 low dose

BI 1060469, TF2, Test DRUG

2 BI 1060469 high dose

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1333.4.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

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: May 6, 2015
• First Posted: May 8, 2015
• Study Start: May 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 24, 2015

Record last verified: 2015-09

Locations

DE (1)