A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood

An Open-label, Fixed-sequence Cross-over, Two-period, Phase I Trial to Evaluate the Effect of Multiple Doses of BI 1358894 on the Pharmacokinetics of a Combination of Ethinylestradiol and Drospirenone in Healthy Female Subjects

This study aims to investigate the effect of multiple doses of BI 1358894 on pharmacokinetics of ethinylestradiol (EE) and drospirenone (DRSP) (Yasmin®)

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 1358894; Drug: Yasmin®

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13627
    • CRS Clinical Research Services Berlin GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy premenopausal female subjects according to the assessment of the investigator, as based on a complete medical history including a physical and gynaecological examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 35 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
4. Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

5. Female subject who meet any of the following criteria for a highly effective contraception from at least 30 days before the first administration of trial medication until 30 days after trial completion:

   • Use of an oral hormonal contraception method in combination with a barrier contraception method and willing to stop the hormonal method and to continue using the barrier method plus Yasmin® for the duration of the trial
   • Use of non-hormonal intrauterine device (IUD)
   • Sexually abstinent
   • Female subject who underwent tubal ligation
   • A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant

Exclusion Criteria:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator (e.g. pronounced varicosis, thrombophlebitis, and evidence of peripheral circulatory disturbances)
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
8. History of relevant orthostatic hypotension, fainting spells, or blackouts

Further exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Yasmin® (Reference treatment (R)) followed by BI 1358894 and Yasmin® (Test treatment (T)); All female participants were treated with 1 daily tablet of the contraceptive Yasmin® (ethinylestradiol and drospirenone) during the run-in period (Day-56 to Day-8). Since the study was discontinued as per protocol after the run-in period, none of the participants received the intended treatments for periods 1 and 2.

Drug: BI 1358894; BI 1358894; Drug: Yasmin®; Ethinylestradiol (EE) and Drospirenone (DRSP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under the Concentration-time Curve of Ethinylestradiol and Drospirenone in Plasma at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)	Planned: pre-dose within 10 minutes before 1st drug administration, and then in period 1 and period 2 post-dose : 480:30, 481:00, 481:30, 482:00, 482:30, 483:00, 483:30, 484:00, 485:00, 486:00, 488:00, 490:00, 492:00, 504:00 hours (h)
Maximum Measured Concentration of Ethinylestradiol and Drospirenone in Plasma at Steady State Over the Uniform Dosing Interval τ (Cmax,ss)	Planned: pre-dose within 10 minutes before 1st drug administration, and then in period 1 and period 2 post-dose : 480:30, 481:00, 481:30, 482:00, 482:30, 483:00, 483:30, 484:00, 485:00, 486:00, 488:00, 490:00, 492:00, 504:00 hours (h)

Secondary Outcome Measures

Outcome Measure	Time Frame
Minimum Measured Concentration of Ethinylestradiol and Drospirenone in Plasma at Steady State Over the Uniform Dosing Interval τ (Cmin,ss)	Planned: pre-dose within 10 minutes before 1st drug administration, and then in period 1 and period 2 post-dose : 480:30, 481:00, 481:30, 482:00, 482:30, 483:00, 483:30, 484:00, 485:00, 486:00, 488:00, 490:00, 492:00, 504:00 hours (h)

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2023
• Primary Completion (Actual): February 8, 2024
• Study Completion (Actual): February 8, 2024

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: June 29, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Drospirenone and ethinyl estradiol combination
• Other Study ID Numbers: 1402-0019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No