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NCT01205373 · ClinicalTrials.gov registry record · Phase 1
A Phase I Trial to Investigate the Metabolism and Pharmacokinetics as Well as Safety and Tolerability of a Single Dose BI671800 HEA Administered as an Oral Solution of the Choline Salt in Healthy Male Volunteers
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT01205373 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 8 participants.
The verdict
NCT01205373, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
The main objectives of the present study are to investigate the basic pharmacokinetics of BI 671800, its major metabolite CD6384, and 14C-radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of 400 mg \[14C\]BI 671800 HEA to healthy male volunteers. Secondary objectives are to evaluate the safety and tolerability following a single oral dose of 400 mg \[14C\]BI 671800 HEA to healthy male volunteers.
Interventions
- DRUG BI 671800
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2010-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01205373
The ClinicalTrials.gov registry entry for NCT01205373 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BI 671800 is the first listed.
NCT01205373 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01205373 about?
NCT01205373 is a clinical study titled "A Phase I Trial to Investigate the Metabolism and Pharmacokinetics as Well as Safety and Tolerability of a Single Dose BI671800 HEA Administered as an Oral Solution of the Choline Salt in Healthy Male Volunteers". The main objectives of the present study are to investigate the basic pharmacokinetics of BI 671800, its major metabolite CD6384, and 14C-radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of 400 mg \[14C\]BI 671800 HEA to healthy male volunteers. S...
What is the current status of trial NCT01205373?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2010-09.
What interventions are being tested in trial NCT01205373?
The interventions under investigation include: BI 671800 (DRUG).
Who is sponsoring clinical trial NCT01205373?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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