NCT02195635

Phase 1, Open-label, Drug-drug Interaction Study With Octreotide Acetate Injection and Telotristat Etiprate in Healthy Subjects

A Phase 1, Open-label, Single-center, 2-period, Single Sequence Drug-drug Interaction Study to Evaluate the Effects of Octreotide Acetate Injection (Sandostatin®) on the Pharmacokinetics of Single-dose Telotristat Etiprate in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To evaluate the effect of octreotide acetate injections (200 µg 3 times daily \[tid\]) on the pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to administration of single-dose telotristat etiprate in healthy male and female subjects

Conditions

• Drug Interactions

Interventions

Type	Name	Description
DRUG	Telotristat etiprate	500 mg telotristat etiprate
DRUG	Octreotide acetate	200 µg octreotide acetate three times daily

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-10-01
• First posted: 2014-07-21
• Last updated: 2016-09-07

Locations

1 site across 1 country: United States