Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Lexicon Pharmaceuticals. The registered enrollment target is 16 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03423446
The ClinicalTrials.gov registry entry for NCT03423446 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lexicon Pharmaceuticals, which has 56 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Telotristat Ethyl is the first listed.
NCT03423446 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.