Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium

Completed · Phase 1 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT02831231

Run by

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

People needed

70

Starts

2016-09-07

Expected to finish

2016-10-28

Last updated by the study team

2017-04-19

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Medpace — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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