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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02831231
Other study ID # KAR-001
Secondary ID
Status Completed
Phase Phase 1
First received July 6, 2016
Last updated April 18, 2017
Start date September 7, 2016
Est. completion date October 28, 2016

Study information

Verified date April 2017
Source Karuna Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date October 28, 2016
Est. primary completion date October 28, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
xanomeline tartrate
xanomeline tartrate, 75 mg capsule, TID
Trospium chloride
trospium chloride, over encapsulated 20 mg tablet, BID

Locations

Country Name City State
United States Medpace Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Karuna Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean weekly maximum composite Visual Analogue Scale (VAS) score (nausea, diarrhea, sweating, salivation and vomiting combined) comparing xanomeline + placebo to xanomeline + trospium 7 days
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