This Study Tests in Healthy Korean Women Which Effects BI 409306 and a Birth-control Pill Have on Each Other

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03193307
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.1
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

The primary objective of this trial is to investigate the effect of multiple doses of ethinylestradiol / levonorgestrel (Microgynon®) on single dose pharmacokinetics of BI 409306 and the effect of single dose of BI 409306 on multiple dose pharmacokinetics of ethinylestradiol / levonorgestrel (Microgynon®)

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Microgynon; Drug: BI 409306	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study to Investigate the Pharmacokinetic Drug-drug Interaction Following Oral Administration of Ethinylestradiol/Levonorgestrel (Microgynon®) and BI 409306 in Healthy Korean Premenopausal Female Subjects (an Open-label, Two-period, Fixed-sequence Study)
• Actual Study Start Date: Jun 29, 2017
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: All subjects Microgynon alone (run in period) then Microgynon & BI 409306 treatment period	Drug: Microgynon; Run in period & Treatment Period; Drug: BI 409306; Day 18 & 29 (Treatment Period)

Outcome Measures

Primary Outcome Measures

1. 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) (BI 409306) [up to 72 hours]

2. Cmax (maximum measured concentration of the analyte in plasma) (BI 409306) [up to 72 hours]

3. AUC0-24,ss (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) (ethinylestradiol and levonorgestrel) [up to 24 hours]

4. Cmax, ss (maximum measured concentration of the analyte in plasma) (ethinylestradiol and levonorgestrel) [up to 24 hours]

Secondary Outcome Measures

1. AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(BI 409306) [up to 24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy CYP2C19 PM genotyped premenopausal female subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests.

• Korean ethnicity according to the following criteria

;be a current Korean passport or national identification card holder, and have parents and grandparents who were all born in Korea

• Age of 19 to 40 years (incl.)

• Body Mass Index (BMI) of 18.5 to 25.0 kg/m2 (incl.)

• Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

• Female subjects who meet any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion:

• Use of adequate contraception, e.g. non-hormonal intrauterine device plus condom

• Sexually abstinent

• A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)

• Surgically sterilised (including hysterectomy)

Exclusion Criteria:

• Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (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 45 to 90 beats per minutes (bpm)

• 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, oncologic 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)

• Use of drugs within 30 days prior to administration of trial medication that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)

• Participation in another trial (including bioequivalence trial) where an investigational drug has been administered within 3 months prior to planned administration of trial medication

• Current smoker or ex-smoker who quit smoking less than 30 days prior to screening

• 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

• 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.

• Any relevant finding of the gynaecological examination

• Thrombotic predisposition according to thrombophilic testing

• Existing or history of arterial thrombotic or embolic processes, conditions which predispose to them e.g. disorders of the clotting processes, valvular heart disease and atrial fibrillation

• Existing or history of confirmed venous thromboembolism, family history of venous thromboembolism, and other known risk factors for venous thromboembolism.

• Relevant varicosis

• Use of hormone-containing intrauterine device, depot injection or contraceptive implants

• Any history of relevant liver diseases (for instance, disturbances of liver function, jaundice or persistent itching during a previous pregnancy, Dubin-Johnson syndrome, Rotor syndrome, or previous or existing liver tumours)

• Any history of migraine with focal neurological symptoms

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT03193307
• Other Study ID Numbers: 1289-0040
• First Posted: Jun 20, 2017
• Last Update Posted: Dec 15, 2017
• Last Verified: Dec 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination; BI 409306

Study Results

No Results Posted as of Dec 15, 2017