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Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

xanomeline tartrate

Trospium chloride

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Medpace

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Xanomeline plus placebo

Xanomeline plus trospium

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean weekly maximum composite Visual Analogue Scale (VAS) score (nausea, diarrhea, sweating, salivation and vomiting combined) comparing xanomeline + placebo to xanomeline + trospium

Secondary Outcome Measures

Full Information

NCT ID

NCT02831231

First Posted

July 6, 2016

Last Updated

April 18, 2017

Sponsor

Karuna Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT02831231

Brief Title

Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

September 7, 2016 (Actual)

Primary Completion Date

October 28, 2016 (Actual)

Study Completion Date

October 28, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Karuna Therapeutics

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Xanomeline plus placebo

Arm Type

Active Comparator

Arm Description

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

Arm Title

Xanomeline plus trospium

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

xanomeline tartrate

Other Intervention Name(s)

LY246708

Intervention Description

xanomeline tartrate, 75 mg capsule, TID

Intervention Type

Drug

Intervention Name(s)

Trospium chloride

Other Intervention Name(s)

Sanctura

Intervention Description

trospium chloride, over encapsulated 20 mg tablet, BID

Primary Outcome Measure Information:

Title

Mean weekly maximum composite Visual Analogue Scale (VAS) score (nausea, diarrhea, sweating, salivation and vomiting combined) comparing xanomeline + placebo to xanomeline + trospium

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lukasz Biernat, PhD

Organizational Affiliation

Medpace, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medpace

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45227

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium

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