HealthyPhase 1NCT03193307

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

A Phase 1 study testing Microgynon® 30 and BI 409306 in people with Healthy, run by Boehringer Ingelheim at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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®) Read more about this study

Who is it for?: Ages 19 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Microgynon® 30 and BI 409306
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteSouth Korea
Study dates: 29 Jun 2017to 1 Dec 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Show all 11Show fewer

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)

Who cannot join

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)

Show all 28Show fewer

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul, 03080

Other trials in South Korea

About this study

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)

Conditions: Healthy
Being tested: Microgynon® 30, BI 409306

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Microgynon® 30Drug
Run in period \& Treatment Period
BI 409306Drug
Day 18 \& 29 (Treatment Period)

Study groups in NCT03193307
Study group	Role	What they receive
Microgynon® 30 +BI 409306 then BI 409306 alone	Experimental	Run in period: Microgynon alone Treatment period: Microgynon® 30 +BI 409306 then BI 409306 alone Receives: Drug: Microgynon® 30; Drug: BI 409306

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
AUC0-tz , area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 to the last quantifiable concentration is presented.
Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'.
Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 14, 24, 36, 48 and 72 hours (h) after single oral administration of 1 tablet of 25 mg BI 409306 together with 1 tablet of Microgynon® 30 (Day 18) and after single administration of one tablet of 25 mg BI 409306 alone (Day 29).
Measured: PK samples were collected 10 min pre-dose and up to 72 h after administration of BI 409306 together with Microgynon® 30 (Day 18) and up to 72 h after administration of BI 409306 alone (Day 29).
Maximum Measured Concentration of BI 409306 in Plasma (Cmax)
Cmax, maximum measured concentration of BI 409306 in plasma is presented. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'.
Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 14, 24, 36, 48 and 72 hours (h) after single oral administration of 1 tablet of 25 mg BI 409306 together with 1 tablet of Microgynon® 30 (Day 18) and after single administration of one tablet of 25 mg BI 409306 alone (Day 29).
Measured: PK samples were collected 10 min pre-dose and up to 72 h after administration of BI 409306 together with Microgynon® 30 (Day 18) and up to 72 h after administration of BI 409306 alone (Day 29).
Area Under the Concentration-time Curve of Ethinylestradiol in Plasma Over the Time Interval From 0 to 24 Hour at Steady State (AUC0-24,ss)
AUC0-24,ss, area under the concentration-time curve of the ethinylestradiol in plasma over the time interval from 0 to 24 hour at steady state.
Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'.
Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI 409306 (Day 18).
Measured: PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18).
Area Under the Concentration-time Curve of Levonorgestrel in Plasma Over the Time Interval From 0 to 24 Hour at Steady State (AUC0-24,ss)
AUC0-24,ss, area under the concentration-time curve of the levonorgestrel in plasma over the time interval from 0 to 24 hour at steady state.
Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'.
Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI 409306 (Day 18).
Measured: PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18).
Maximum Measured Concentration of Ethinylestradiol in Plasma at Steady State (Cmax,ss)
Cmax,ss, maximum measured concentration of ethinylestradiol in plasma at steady state is presented.
Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'.
Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI409306 (Day 18).
Measured: PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18).
Maximum Measured Concentration of Levonorgestrel in Plasma at Steady State (Cmax,ss)
Cmax,ss, maximum measured concentration of levonorgestrel in plasma at steady state is presented.
Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'.
Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI409306 (Day 18).
Measured: PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18).

Secondary outcomes (1)

Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)
AUC0-infinity, area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 extrapolated to infinity is presented.
Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'.
Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 14, 24, 36, 48 and 72 hours (h) after single oral administration of 1 tablet of 25 mg BI 409306 together with 1 tablet of Microgynon® 30 (Day 18) and after single administration of 1 tablet of 25 mg BI 409306 alone (Day 29).
Measured: PK samples were collected 10 min pre-dose and up to 72h after administration of BI 409306 together with Microgynon® 30 (Day 18) and up to 72 h after administration of BI 409306 alone (Day 29).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jun 20171 Dec 2017

First posted20 Jun 2017
Study start29 Jun 2017
Primary completion1 Dec 2017
Study completion1 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03193307
Sponsor's protocol ID: 1289-0040
Status last verified: Aug 2023
First submitted: 19 Jun 2017
Last updated: 13 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT03193307
Acronym / sponsor ID: 1289-0040
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 29 Jun 2017 (actual)
Primary completion: 1 Dec 2017 (actual)
Study completion: 1 Dec 2017 (actual)
First posted: 20 Jun 2017 (actual)
Results: Posted 13 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Microgynon® 30 +BI 409306 then BI 409306 alone	Experimental	Drug: Microgynon® 30, Drug: BI 409306Run in period: Microgynon alone Treatment period: Microgynon® 30 +BI 409306 then BI 409306 alone

Who may qualify

Ages: 19 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

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.)

Key exclusion criteria (28 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Microgynon® 30Run in period \& Treatment Period	Drug	Microgynon® 30 +BI 409306 then BI 409306 alone
BI 409306Day 18 \& 29 (Treatment Period)	Drug	Microgynon® 30 +BI 409306 then BI 409306 alone

Primary outcome

Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: PK samples were collected 10 min pre-dose and up to 72 h after administration of BI 409306 together with Microgynon® 30 (Day 18) and up to 72 h after administration of BI 409306 alone (Day 29).
AUC0-tz , area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 to the last quantifiable concentration is presented. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 14, 24, 36, 48 and 72 hours (h) after single oral administration of 1 tablet of 25 mg BI 409306 together with 1 tablet of Microgynon® 30 (Day 18) and after single administration of one tablet of 25 mg BI 409306 alone (Day 29).
Maximum Measured Concentration of BI 409306 in Plasma (Cmax)
Time frame: PK samples were collected 10 min pre-dose and up to 72 h after administration of BI 409306 together with Microgynon® 30 (Day 18) and up to 72 h after administration of BI 409306 alone (Day 29).
Cmax, maximum measured concentration of BI 409306 in plasma is presented. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 14, 24, 36, 48 and 72 hours (h) after single oral administration of 1 tablet of 25 mg BI 409306 together with 1 tablet of Microgynon® 30 (Day 18) and after single administration of one tablet of 25 mg BI 409306 alone (Day 29).
Area Under the Concentration-time Curve of Ethinylestradiol in Plasma Over the Time Interval From 0 to 24 Hour at Steady State (AUC0-24,ss)
Time frame: PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18).
AUC0-24,ss, area under the concentration-time curve of the ethinylestradiol in plasma over the time interval from 0 to 24 hour at steady state. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI 409306 (Day 18).
Area Under the Concentration-time Curve of Levonorgestrel in Plasma Over the Time Interval From 0 to 24 Hour at Steady State (AUC0-24,ss)
Time frame: PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18).
AUC0-24,ss, area under the concentration-time curve of the levonorgestrel in plasma over the time interval from 0 to 24 hour at steady state. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI 409306 (Day 18).
Maximum Measured Concentration of Ethinylestradiol in Plasma at Steady State (Cmax,ss)
Time frame: PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18).
Cmax,ss, maximum measured concentration of ethinylestradiol in plasma at steady state is presented. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI409306 (Day 18).
Maximum Measured Concentration of Levonorgestrel in Plasma at Steady State (Cmax,ss)
Time frame: PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18).
Cmax,ss, maximum measured concentration of levonorgestrel in plasma at steady state is presented. Geometric Least Squares Mean and adjusted geometric standard error were derived from an Analysis of variance (ANOVA) model which included random effect for 'subject' and fixed effect for 'treatment'. Pharmacokinetics samples were collected 10 minutes (min) pre-dose, 0.5, 1, 1.5, 2, 4, 8, 14 and 24 hours (h) after single oral administration of 1 tablet Microgynon® 30 (Day 17) and after single administration of 1 tablet Microgynon® 30 together with one tablet of 25 mg BI409306 (Day 18).

1 secondary outcome

Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)
Time frame: PK samples were collected 10 min pre-dose and up to 72h after administration of BI 409306 together with Microgynon® 30 (Day 18) and up to 72 h after administration of BI 409306 alone (Day 29).

Results and safety

Results posted to the registry on 13 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Microgynon® 30 + BI 409306 Then BI 409306 Alone	16	16

Primary outcome: Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

Time frame: PK samples were collected 10 min pre-dose and up to 72 h after administration of BI 409306 together with Microgynon® 30 (Day 18) and up to 72 h after administration of BI 409306 alone (Day 29).. Geometric least squares mean (Standard Error). Unit: nanomoles*hour/Litre [nmol*h/L]

Measure	BI 409306 + Microgynon® 30 (T1) n = 16	BI 409306 Alone (R1) n = 16
Value	5931.13 (NA)	3871.50 (NA)

BI 409306 + Microgynon® 30 (T1) vs BI 409306 Alone (R1): Geometric Mean (T1/R1) ratio (%): 153.20 (90% CI 134.34 to 174.70)

Population analysed: Pharmacokinetic (PK) set (PKS): The PKS included all subjects in the treated set (TS) who provided at least one primary or secondary PK parameter value for one period to the statistical assessment and was not excluded from the study as predefined in the Trial statistical analysis plan (TSAP).

Primary outcome: Maximum Measured Concentration of BI 409306 in Plasma (Cmax)

Measure	BI 409306 + Microgynon® 30 (T1) n = 16	BI 409306 Alone (R1) n = 16
Value	1786.026 (NA)	1540.816 (NA)

BI 409306 + Microgynon® 30 (T1) vs BI 409306 Alone (R1): Geometric Mean (T1/R1) ratio (%): 115.91 (90% CI 104.559 to 128.502)

Primary outcome: Area Under the Concentration-time Curve of Ethinylestradiol in Plasma Over the Time Interval From 0 to 24 Hour at Steady State (AUC0-24,ss)

Time frame: PK samples were collected 10 min pre-dose and up to 24 h after administration of Microgynon® 30 (Day 17) and up to 24 h after administration of Microgynon® 30 together with BI 409306 (Day 18).. Geometric least squares mean (Standard Error). Unit: Picograms*hour/millilitre [pg*h/mL]

Measure	Microgynon® 30 + BI 409306 (T2) n = 16	Microgynon® 30 Alone (R2) n = 16
Value	921.880 (NA)	879.521 (NA)

Microgynon® 30 + BI 409306 (T2) vs Microgynon® 30 Alone (R2): Geometric Mean (T2/R2) ratio (%): 104.82 (90% CI 102.092 to 107.613)

Primary outcome: Area Under the Concentration-time Curve of Levonorgestrel in Plasma Over the Time Interval From 0 to 24 Hour at Steady State (AUC0-24,ss)

Measure	Microgynon® 30 + BI 409306 (T2) n = 16	Microgynon® 30 Alone (R2) n = 16
Value	86110.14 (NA)	83791.03 (NA)

Microgynon® 30 + BI 409306 (T2) vs Microgynon® 30 Alone (R2): Geometric Mean (T2/R2) ratio (%): 102.77 (90% CI 100.66 to 104.92)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From first drug administration until 6 days after last drug administration, up to 35 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Microgynon® 30 Alone (R2)	0 of 16 (0%)	9 of 16 (56.3%)	0 of 16
BI 409306 + Microgynon® 30 (T1)	0 of 16 (0%)	11 of 16 (68.8%)	0 of 16
BI 409306 Alone (R1)	0 of 16 (0%)	12 of 16 (75%)	0 of 16
Total BI409306	0 of 16 (0%)	14 of 16 (87.5%)	0 of 16
Microgynon® 30 + BI 409306 Then BI 409306 Alone	0 of 16 (0%)	15 of 16 (93.8%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Microgynon® 30 and BI 409306 in people with Healthy, run by Boehringer Ingelheim at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (time frame: PK samples were collected 10 min pre-dose and up to 72 h after administration of BI 409306 together with Microgynon® 30 (Day 18) and up to 72 h after administration of BI 409306 alone (Day 29).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03193307.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.