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Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium

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ClinicalTrials.gov Identifier: NCT02831231
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: xanomeline tartrate Drug: Trospium chloride Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 7, 2016
Primary Completion Date : October 28, 2016
Study Completion Date : October 28, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Xanomeline plus placebo
Drug: Xanomeline tartrate 75 mg TID, for 225 mg total daily dose Placebo, TID
Drug: xanomeline tartrate
xanomeline tartrate, 75 mg capsule, TID
Other Name: LY246708
Experimental: 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
Drug: xanomeline tartrate
xanomeline tartrate, 75 mg capsule, TID
Other Name: LY246708
Drug: Trospium chloride
trospium chloride, over encapsulated 20 mg tablet, BID
Other Name: Sanctura


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831231


Locations
United States, Ohio
Medpace
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
Karuna Pharmaceuticals
Investigators
Principal Investigator: Lukasz Biernat, PhD Medpace, Inc.
More Information

Responsible Party: Karuna Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02831231     History of Changes
Other Study ID Numbers: KAR-001
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Trospium chloride
Xanomeline
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents
Parasympathomimetics
Psychotropic Drugs
Muscarinic Agonists
Cholinergic Agonists