Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium

NCT ID: NCT02831231

Last Updated: 2017-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-07
• Study Completion Date: 2016-10-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Xanomeline plus placebo

Drug: Xanomeline tartrate 75 mg TID, for 225 mg total daily dose Placebo, TID

Group Type: ACTIVE_COMPARATOR

xanomeline tartrate

Intervention Type: DRUG

xanomeline tartrate, 75 mg capsule, TID

Xanomeline plus trospium

Drug: Xanomeline tartrate 75 mg TID, for 225 mg total daily dose Drug: Trospium chloride 20 mg BID, for a 40 mg total daily dose

Group Type: EXPERIMENTAL

xanomeline tartrate

Intervention Type: DRUG

xanomeline tartrate, 75 mg capsule, TID

Trospium chloride

Intervention Type: DRUG

trospium chloride, over encapsulated 20 mg tablet, BID

Interventions

xanomeline tartrate

xanomeline tartrate, 75 mg capsule, TID

Intervention Type: DRUG

Trospium chloride

trospium chloride, over encapsulated 20 mg tablet, BID

Intervention Type: DRUG

Other Intervention Names

LY246708; Sanctura

Eligibility Criteria

Inclusion Criteria

• Female subjects must be postmenopausal (at least 2 years prior to dosing) or agree to use an acceptable form of birth control from screening until 14 days after completion of the study. If on birth control pills, have been on a stable dose for≥12 months.
• Good general health
• Ability to give informed consent and understand verbal instructions
• Willingness to spend 10 days in an in-patient facility

Exclusion Criteria

• History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results. (Subjects with any history of resolved cancer that is >5 years passed can be included.)
• Body Mass Index <18 or > 40 kg/m2
• History of or high risk of urinary retention, gastric retention, or narrow-angle glaucoma
• History of alcohol or drug abuse within the last 24 months, or current abuse as determined by urine toxicology screen
• Clinically significant abnormal finding on the physical exam, medical history, ECG, or clinical laboratory results at screening
• Has participated in another clinical trial within 90 days prior to the first dose of study medication
• Needs to take any prescription medication besides the investigational product or those specifically noted above.

Use of any vitamins, herbs, supplements, or over the counter medications are excluded within one week of enrollment, and during the course of the trial. Specifically, subjects may not take Benadryl® for one week prior and during the course of the study.

• Use of any tobacco products within the past 30 days
• Previous positive test for HIV 1 and/or 2, or Hepatitis A, B, or C, or a positive test obtained at screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karuna Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lukasz Biernat, PhD

Role: PRINCIPAL_INVESTIGATOR

Medpace, Inc.

Locations

Medpace

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

KAR-001

Identifier Type: -

Identifier Source: org_study_id