NCT07526194
Not yet recruiting
Phase 1
A Phase I Single-blind, Randomised, Placebo-controlled, Parallel Group Design Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BI 3821001 Administered to Healthy Trial Participants
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
Overview
Brief Summary
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3821001 in healthy male trial participants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male 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
- •Age of 18 to 55 years (inclusive)
- •Body mass idnex (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
- •Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply
Exclusion Criteria
- •Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- •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
- •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
Arms & Interventions
Placebo group
Placebo Comparator
Intervention: Placebo (Drug)
Dose group 2
Experimental
part A
Intervention: BI 3821001 (Drug)
Dose group 3
Experimental
part A
Intervention: BI 3821001 (Drug)
Dose group 1
Experimental
part A
Intervention: BI 3821001 (Drug)
Dose group 4
Experimental
part A
Intervention: BI 3821001 (Drug)
Dose group 5
Experimental
part A
Intervention: BI 3821001 (Drug)
Dose group 6
Experimental
part A
Intervention: BI 3821001 (Drug)
Dose group 7
Experimental
part B
Intervention: BI 3821001 (Drug)
Dose group 8
Experimental
part B
Intervention: BI 3821001 (Drug)
Dose group 9
Experimental
part B
Intervention: BI 3821001 (Drug)
Outcomes
Primary Outcomes
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
Time Frame: Up to 60 days
Secondary Outcomes
- Area under the concentration-time curve of the analyte in blood over the time interval from 0 extrapolated to infinity (AUC0-∞)(Up to 60 days)
- Maximum measured concentration of the analyte in blood (Cmax)(Up to 60 days)
- Percentage of participants treated with investigational drug who experience a treatment-emergent adverse event(Up to 60 days)
Investigators
Study Sites (1)
Loading locations...
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