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Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium

NCT02831231 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2017-04-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

xanomeline tartrate

xanomeline tartrate, 75 mg capsule, TID

DRUG

Trospium chloride

trospium chloride, over encapsulated 20 mg tablet, BID

Sponsors & Collaborators

  • Karuna Therapeutics

    lead INDUSTRY

Principal Investigators

  • Lukasz Biernat, PhD · Medpace, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-07
Primary Completion
2016-10-28
Completion
2016-10-28

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02831231 on ClinicalTrials.gov