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NCT03423446 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Pharmacokinetics of Telotristat Ethyl in Subjects With Severe Hepatic Impairment
A Phase 1 study, sponsored by Lexicon Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT03423446: Completed Phase 1 study, sponsored by Lexicon Pharmaceuticals.
NCT03423446 is a Phase 1 study that has completed, run by Lexicon Pharmaceuticals. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03423446, a Phase 1 study, has completed, sponsored by Lexicon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This study is designed to evaluate the effect of severe hepatic impairment on the pharmacokinetics (PK) of telotristat ethyl (TE) ( LP-778902 active moiety, metabolite), following administration of a single dose of TE 250 mg (1 x 250-mg tablet) compared to healthy, demographically-matched subjects with normal hepatic function.
Interventions
- DRUG Telotristat Ethyl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2017-11-28 |
| Est. Completion | 2018-06-15 |
| Phase | Phase 1 |
What the finished NCT03423446 record still lists
NCT03423446 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Telotristat Ethyl is the first listed.
NCT03423446 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03423446 about?
NCT03423446 is a clinical study titled "Study to Evaluate the Pharmacokinetics of Telotristat Ethyl in Subjects With Severe Hepatic Impairment". This study is designed to evaluate the effect of severe hepatic impairment on the pharmacokinetics (PK) of telotristat ethyl (TE) ( LP-778902 active moiety, metabolite), following administration of a single dose of TE 250 mg (1 x 250-mg tablet) compared to healthy, demographically-matched subjects w...
What is the current status of trial NCT03423446?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2017-11-28. Estimated completion is 2018-06-15.
What interventions are being tested in trial NCT03423446?
The interventions under investigation include: Telotristat Ethyl (DRUG).
Who is sponsoring clinical trial NCT03423446?
This trial is sponsored by Lexicon Pharmaceuticals, which has 56 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03423446's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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