NCT02831231

Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium

A Phase I, Double-Blind, Randomized, Multiple-Dose, Pilot Study Comparing Xanomeline Administered Alone to Xanomeline Administered in Combination With Trospium Chloride in Normal Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study is intended to determine whether the addition of trospium chloride to xanomeline tartrate will ameliorate the peripheral cholinergic side effects that have been previously experienced with xanomeline tartrate when administered alone.

Detailed description

In this inpatient study, volunteers will received either xanomeline alone, or xanomeline plus trospium for 7 days. Subjects will report cholinergic side effects daily via visual analog scales, for each of nausea, vomiting, diarrhea, sweating and excessive salivation. Clinician administered scales will also be administered daily for assessment of the same cholinergic side effects.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	xanomeline tartrate	xanomeline tartrate, 75 mg capsule, TID
DRUG	Trospium chloride	trospium chloride, over encapsulated 20 mg tablet, BID

Timeline

• Start date: 2016-09-07
• Primary completion: 2016-10-28
• Completion: 2016-10-28
• First posted: 2016-07-13
• Last updated: 2017-04-19

Locations

1 site across 1 country: United States