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

NCT05934942 | Terminated Phase 1 Results

• 1 other identifier: 1402-0019
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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)

Study Arms (1)

Yasmin® (Reference treatment (R)) followed by BI 1358894 and Yasmin® (Test treatment (T))

EXPERIMENTAL

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: Yasmin®; Drug: BI 1358894

Interventions

Yasmin® DRUG

Ethinylestradiol (EE) and Drospirenone (DRSP)

Yasmin® (Reference treatment (R)) followed by BI 1358894 and Yasmin® (Test treatment (T))

BI 1358894 DRUG

BI 1358894

Yasmin® (Reference treatment (R)) followed by BI 1358894 and Yasmin® (Test treatment (T))

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Age of 18 to 35 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
• 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
• 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

You may not qualify if:

• 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)
• 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)
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

CRS Clinical Research Services Berlin GmbH

Berlin, 13627, Germany

Location

Related Links

• Related Info

MeSH Terms

Interventions

drospirenone and ethinyl estradiol combination; TRPC inhibitor BI 1358894

Limitations and Caveats

The study was prematurely discontinued as per protocol during the run-in period and no data for the primary and secondary pharmacokinetic endpoints could be collected, and the statistical evaluations were not performed.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 7, 2023
• Study Start: September 8, 2023
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: February 24, 2025
• Results First Posted: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)