NCT03302845

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

A Phase 1, Open-label, Parallel Group, Drug-drug Pharmacokinetic Interaction Study to Evaluate the Effects of Multiple-dose Omeprazole and Famotidine on the Absorption of Single-dose Telotristat Ethyl in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Drug-drug Interaction

Interventions

Type	Name	Description
DRUG	Omeprazole 40 MG	Omeprazole 40 mg capsule
DRUG	Famotidine 40 mg	Famotidine 40 mg tablet
DRUG	Telotristat ethyl 250 mg	Telotristat ethyl 250 mg tablet

Timeline

• Start date: 2017-09-21
• Primary completion: 2017-10-23
• Completion: 2017-11-07
• First posted: 2017-10-05
• Last updated: 2018-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study