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NCT03302845 · ClinicalTrials.gov registry record · Phase 1

A Phase 1 Study to Evaluate the Effects of Omeprazole and Famotidine on the Absorption of Telotristat Ethyl in Healthy Subjects

A Phase 1 study, sponsored by Lexicon Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
32
Enrollment target

NCT03302845: Completed Phase 1 study, sponsored by Lexicon Pharmaceuticals.

NCT03302845 is a Phase 1 study that has completed, run by Lexicon Pharmaceuticals. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03302845, a Phase 1 study, has completed, sponsored by Lexicon Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
32 participants
Enrollment target

Study Summary

This drug-drug interaction study will evaluate the impact of two different acid reducing agents (from two different drug classes) co-administered with a single dose of telotristat ethyl.

Primary Outcome

Maximum observed concentration of telotristat ethyl

Interventions

  • DRUG Omeprazole 40 MG
  • DRUG Famotidine 40 mg
  • DRUG Telotristat ethyl 250 mg

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2017-09-21
Est. Completion 2017-11-07
Phase Phase 1
Lexicon Pharmaceuticals

56 total trials

What the finished NCT03302845 record still lists

NCT03302845 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).

The record links to 0 conditions, and to 3 interventions - of which Omeprazole 40 MG is the first listed.

NCT03302845 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03302845 about?

NCT03302845 is a clinical study titled "A Phase 1 Study to Evaluate the Effects of Omeprazole and Famotidine on the Absorption of Telotristat Ethyl in Healthy Subjects". This drug-drug interaction study will evaluate the impact of two different acid reducing agents (from two different drug classes) co-administered with a single dose of telotristat ethyl.

What is the current status of trial NCT03302845?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2017-09-21. Estimated completion is 2017-11-07.

What interventions are being tested in trial NCT03302845?

The interventions under investigation include: Omeprazole 40 MG (DRUG), Famotidine 40 mg (DRUG), Telotristat ethyl 250 mg (DRUG).

Who is sponsoring clinical trial NCT03302845?

This trial is sponsored by Lexicon Pharmaceuticals, which has 56 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03302845's enrollment target sits among peer trials

32 1296th of 2000 higher than 679 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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Source: ClinicalTrials.gov NCT03302845, the US trial registry maintained by the National Library of Medicine. NCT03302845 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.