A Study in Healthy Men to Compare the Amount of Vicadrostat and Empagliflozin in the Blood When Taken Separately and Together

Boehringer Ingelheim

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Jardiance®; Drug: Vicadrostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT07035457

U1111-1313-3279 (Registry Identifier)

2024-518103-21-00 (Registry Identifier)

1378-0024

Details and patient eligibility

About

The main objective of this trial is to investigate the relative bioavailability of vicadrostat and empagliflozin when administered in combination or individually.

Enrollment: 16 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

• Healthy male subjects 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
• Age of 18 to 55 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 kg/m^2 (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

Exclusion Criteria :

• Any finding in the medical examination (including ECG) deviating from normal and assessed as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 105 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 65 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 Further exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

Treatment sequence A: R1-R2-T

Experimental group

Description:

Reference 1 (R1): vicadrostat Reference 2 (R2): empagliflozin Test (T): vicadrostat and empagliflozin taken together

Treatment:

Drug: Vicadrostat

Drug: Jardiance®

Treatment sequence B: R2-T-R1

Experimental group

Description:

Reference 1 (R1): vicadrostat Reference 2 (R2): empagliflozin Test (T): vicadrostat and empagliflozin taken together

Treatment:

Drug: Vicadrostat

Drug: Jardiance®

Treatment sequence C: T-R1-R2

Experimental group

Description:

Reference 1 (R1): vicadrostat Reference 2 (R2): empagliflozin Test (T): vicadrostat and empagliflozin taken together

Treatment:

Drug: Vicadrostat

Drug: Jardiance®