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NCT07837648
A Study to Test How Much BI 3034701 Gets Into the Blood in Healthy People When Given in Two Different Ways
Conditions: Healthy
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 30
Sponsor: Boehringer Ingelheim
Location: Quotient Sciences Nottingham
Summary
The aim of the trial is to investigate relative bioavailability of BI 3034701 treatment T vs. BI 3034701 treatment R.
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) 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.
Source: ClinicalTrials.gov (NCT07837648). StuddyBuddy aggregates publicly available trial information.