NCT02831231

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_1 schizophrenia

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 7, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2016

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

2 months

First QC Date

July 6, 2016

Last Update Submit

April 18, 2017

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

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

    7 days

Study Arms (2)

Xanomeline plus placebo

ACTIVE COMPARATOR

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

Drug: xanomeline tartrate

Xanomeline plus trospium

EXPERIMENTAL

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

Drug: xanomeline tartrateDrug: Trospium chloride

Interventions

xanomeline tartrateDRUG

xanomeline tartrate, 75 mg capsule, TID

Also known as: LY246708
Xanomeline plus placeboXanomeline plus trospium
Trospium chlorideDRUG

trospium chloride, over encapsulated 20 mg tablet, BID

Also known as: Sanctura
Xanomeline plus trospium

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medpace

Cincinnati, Ohio, 45227, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

xanomelinetrospium chloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Lukasz Biernat, PhD

    Medpace, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 13, 2016

Study Start

September 7, 2016

Primary Completion

October 28, 2016

Study Completion

October 28, 2016

Last Updated

April 19, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)