Clinical Trials in the UK / NCT07837648
Recruiting
Phase 1
A Study to Test How Much BI 3034701 Gets Into the Blood in Healthy People When Given in Two Different Ways
NCT07837648 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Healthy
Investigational drug(s) / intervention(s)
BI3034701 formulation IIBI3034701 formulation C1
BI3034701 formulation II: BI3034701 formulation II (reference treatment)
BI3034701 formulation C1: BI3034701 formulation C1 (test treatment)
Study summary
The aim of the trial is to investigate relative bioavailability of BI 3034701 treatment T vs. BI 3034701 treatment R.
Eligibility
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.
Primary outcome measure(s)
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) — Up to 19 days.
- Maximum measured concentration of the analyte in plasma (Cmax) — Up to 19 days.
Highest observed plasma concentrations within the time interval.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Quotient Sciences | Nottingham | United Kingdom | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07837648 on ClinicalTrials.gov ↗ ← All trials in the UK