Effect of Multiple BI 1356 Doses of on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Female Premenopausal Subjects

NCT02175394 | Completed Phase 1

• 1 other identifier: 1218.44
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective was to investigate the effect of multiple oral doses of 5 mg BI 1356 on the steady-state pharmacokinetics of ethinylestradiol (EE) and levonorgestrel (LNG), the components of Microgynon®

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve of ethinylestradiol and levonogestrel (Microgynon®) in plasma over the dosing interval at steady-state (AUCτ,ss)

  On day 14 and on day 21

• Maximum measured concentration of ethinylestradiol and levonogestrel (Microgynon®) in plasma at steady state (Cmax,ss)

  On day 14 and on day 21

Secondary Outcomes (14)

• Time from last dosing to the maximum measured concentration of EE and LNG in plasma at steady state (tmax,ss)

  Up to day 22 after start of treatment

• Apparent clearance of EE and LNG in plasma following extravascular administration at steady state (CL/F,ss)

  Up to day 22 after start of treatment

• Apparent volume of distribution of EE and LNG during the terminal phase λz at steady state following extravascular administration (Vz/F,ss)

  Up to day 22 after start of treatment

• Terminal half-life of EE and LNG in plasma at steady state (t1/2,ss)

  Up to day 22 after start of treatment

• Terminal rate constant of EE and LNG in plasma at steady state (λz,ss)

  Up to day 22 after start of treatment

Study Arms (2)

Microgynon®

ACTIVE COMPARATOR

Microgynon® once daily during period 1 (day 1 to day 14)

Drug: Microgynon®

Microgynon® and BI 1356

EXPERIMENTAL

Microgynon® combined with BI 1356, once daily during period 2 (day 15 to day 21)

Drug: Microgynon®; Drug: BI 1356

Interventions

Microgynon® DRUG

Microgynon®; Microgynon® and BI 1356

BI 1356 DRUG

Microgynon® and BI 1356

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy premenopausal female subjects as determined by the results of screening based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), heart rate (HR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
• Age 18 - 40 years
• BMI 18.5 - 27 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
• Gynaecological examination without relevant findings

You may not qualify if:

• Any finding of the medical examination deviating from normal and of clinical relevance. Systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
• 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 or hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs with a long half-life (greater than 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to day 1 or during the trial
• Use of antibiotics and drugs known to inhibit or induce cytochrome P450 enzymes, especially CYP3A4, within one month prior to study day 1 or during the trial (CYP3A4 inhibitors are for example azole antimycotics, macrolides, CYP3A inducers are for example St. John's Wort or certain anticonvulsants)
• Participation in another trial with an investigational drug within two months prior to day 1 or during the trial
• Regular smokers of more than two cigarettes daily
• Drug or alcohol abuse (more than 20 g alcohol/day)
• Blood donation (more than 100 mL within four weeks prior to day 1)
• Excessive physical activities within 48 hours prior to day 1)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

ethinyl estradiol, levonorgestrel drug combination; Linagliptin

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: June 26, 2014
• Study Start: July 1, 2008
• Primary Completion: October 1, 2008
• Last Updated: July 8, 2014

Record last verified: 2014-07