A Study in Healthy People to Test How 2 Different Formulations of a Combination Treatment (Vicadrostat and Empagliflozin) Are Taken up in the Body and How Food Influences the Amount of the Medicines in the Blood

NCT ID: NCT07133399

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-08
• Study Completion Date: 2025-10-22

Brief Summary

To investigate the relative bioavailability of two different vicadrostat/empagliflozin combinations. Additionally, the trial investigates the effect of food on the pharmacokinetics of the vicadrostat/empagliflozin.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

R -T1 -T2

R = reference (vicadrostat / empagliflozin combination 1) fasted T1 = test 1 (vicadrostat / empagliflozin 2) fasted T2 = test 2 (vicadrostat / empagliflozin 1) fed

Group Type: EXPERIMENTAL

vicadrostat / empagliflozin combination 1

Intervention Type: DRUG

vicadrostat / empagliflozin combination 1

vicadrostat / empagliflozin 2

Intervention Type: DRUG

vicadrostat / empagliflozin 2

T1 - R - T2

R = reference (vicadrostat / empagliflozin combination 1) fasted T1 = test 1 (vicadrostat / empagliflozin 2) fasted T2 = test 2 (vicadrostat / empagliflozin 1) fed

Group Type: EXPERIMENTAL

vicadrostat / empagliflozin combination 1

Intervention Type: DRUG

vicadrostat / empagliflozin combination 1

vicadrostat / empagliflozin 2

Intervention Type: DRUG

vicadrostat / empagliflozin 2

Interventions

vicadrostat / empagliflozin combination 1

vicadrostat / empagliflozin combination 1

Intervention Type: DRUG

vicadrostat / empagliflozin 2

vicadrostat / empagliflozin 2

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy male or female trial participant according to the assessment of the investigator, as 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

2. Age of 18 to 55 years (inclusive)

3. Body Mass Index (BMI) of 18.5 to 29.9 kg / m^2 (inclusive)

4. Signed and dated written informed consent in accordance with Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

5. For female trial participants: Female trial participants 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 combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal), plus condom
• Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus condom
• Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) plus condom
• Sexually abstinent (if refraining from heterosexual intercourse is the preferred and usual lifestyle of the subject).
• 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
• Surgically sterilised (including hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or bilateral tubal ligation)
• Postmenopausal, defined as no menses for 1 year without an alternative medical cause.

Exclusion Criteria

1. Any finding in the medical examination (including Blood pressure (BP) Pulse rate (PR) or ECG) deviating from normal and assessed as clinically relevant by the investigator

2. Repeated measurement of systolic blood pressure outside the range of 105 to 140 mmHg, diastolic blood pressure outside the range of 65 to 90 mmHg, or pulse rate outside the range of 50 to 90 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CRS Clinical Research Services Mannheim GmbH

Mannheim, , Germany

Countries

Germany

Related Links

http://www.mystudywindow.com

Related Info

Other Identifiers

2025-521650-42-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1319-1746

Identifier Type: REGISTRY

Identifier Source: secondary_id

1378-0043

Identifier Type: -

Identifier Source: org_study_id