A Study to Test How Much BI 3034701 Gets Into the Blood in Healthy People When Given in Two Different Ways

Boehringer Ingelheim

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: BI3034701 formulation II; Drug: BI3034701 formulation C1

Study type: Interventional

Funder types: Industry

Identifiers

NCT07837648

1507-0013

U1111-1340-3486 (Registry Identifier)

Details and patient eligibility

About

The aim of the trial is to investigate relative bioavailability of BI 3034701 treatment T vs. BI 3034701 treatment R.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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) at screening
3. Body mass index (BMI) of 20.0 to 32.0 kg/m^2 (inclusive) at screening
4. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) and local legislation prior to admission to the trial
5. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.

Exclusion criteria

1. Any finding in the medical examination (including BP, PR or ECG) deviating from and assessed as clinically relevant by the investigator
2. 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 50 to 90 bpm
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Further exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Reference treatment (R), then Test treatment (T)

Experimental group

Description:

BI3034701 formulation II (R), then BI3034701 formulation C1 (T)

Treatment:

Drug: BI3034701 formulation C1

Drug: BI3034701 formulation II

Test treatment (T), then Reference treatment (R)

Experimental group

Description:

BI3034701 formulation C1 (T), then BI3034701 formulation II (R)

Treatment:

Drug: BI3034701 formulation C1

Drug: BI3034701 formulation II