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NCT05203289 · ClinicalTrials.gov registry record · Phase 1
A Study in Healthy People to Test How 2 Different Formulations of BI 695501 Are Taken up by the Body When Given as an Injection
A Phase 1 study of Healthy, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 200
- Enrollment target
- 2
- Study locations
NCT05203289: Completed Phase 1 study of Healthy, sponsored by Boehringer Ingelheim.
NCT05203289 is a Phase 1 study of Healthy that has completed, run by Boehringer Ingelheim. The registered enrollment target is 200 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (69% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05203289, a Phase 1 study of Healthy, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 200 participants
- Enrollment target
- 2
- Study locations
Study Summary
The main objective of this trial is to compare the pharmacokinetics (PK) of 40 mg BI 695501 100 mg/mL with 40 mg BI 695501 50 mg/mL following single subcutaneous administration.
Primary Outcome
Area under the concentration-time curve of BI 695501 in plasma over the time interval from 0 to 1344 hours after dose administration (AUC0-1344). The presented means are adjusted based on analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment, location of trial medication injection and baseline body weight.
Conditions Studied
Interventions
- DRUG BI 695501 - higher concentration
- DRUG BI 695501 - lower concentration
Study Locations (2)
Florida
- Miami Research Associates, Inc - Miami
Missouri
- QPS MO - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2022-02-18 |
| Est. Completion | 2022-08-29 |
| Phase | Phase 1 |
What the finished NCT05203289 record still lists
NCT05203289 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which BI 695501 - higher concentration is the first listed.
NCT05203289 reports a single indexed study location in Florida, Missouri.
Frequently Asked Questions
What is clinical trial NCT05203289 about?
NCT05203289 is a clinical study titled "A Study in Healthy People to Test How 2 Different Formulations of BI 695501 Are Taken up by the Body When Given as an Injection". The main objective of this trial is to compare the pharmacokinetics (PK) of 40 mg BI 695501 100 mg/mL with 40 mg BI 695501 50 mg/mL following single subcutaneous administration.
What is the current status of trial NCT05203289?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 200 participants. The study started on 2022-02-18. Estimated completion is 2022-08-29.
What conditions does trial NCT05203289 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT05203289?
The interventions under investigation include: BI 695501 - higher concentration (DRUG), BI 695501 - lower concentration (DRUG).
Who is sponsoring clinical trial NCT05203289?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05203289 being conducted?
This trial has 2 study locations across Florida, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05203289's enrollment target sits among peer trials
200 118th of 1090 higher than 965 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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