Safety Study of RP-1127 (Glyburide for Injection) in Healthy Volunteers
Information source: Remedy Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Traumatic Brain Injury; Stroke
Intervention: RP-1127 (Glyburide for injection) (Drug); Placebo (RP-1127 excipients, excluding active) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Remedy Pharmaceuticals, Inc.
Summary
The primary objective of this study is to evaluate the safety and tolerability of RP-1127
(glyburide for injection), administered as a bolus dose followed by a 3 day continuous
infusion. The secondary objectives are to assess the pharmacokinetics of RP-1127 and blood
glucose and serum insulin PD responses to RP-1127.
Clinical Details
Official title: A Phase I Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Escalating Doses of RP-1127 (Glyburide for Injection) in Healthy Male and Female Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Between 18 and 55 years of age, inclusive.
2. A healthy male or a healthy nonpregnant, nonlactating female.
3. Capable of understanding and complying with the protocol and has signed the informed
consent form before the Screening procedures begin.
4. Have a body mass index of between 18. 0 and 30. 0 kg/m², inclusive.
5. A clinically normal physical examination, 12-lead electrocardiogram (ECG), screening
laboratory studies and urinalysis.
6. A negative urine or saliva test for selected substances of abuse and cotinine.
Exclusion Criteria:
1. Clinically significant history of hypoglycemia as assessed by the investigator.
2. History of seizure disorder, even if currently not receiving anticonvulsant
medications.
3. History of adverse reaction to glyburide, other sulfonylurea class of anti-diabetic
medications, or other sulfa drugs.
4. Glucose-6-phosphate dehydrogenase (G6PD) deficiency as determined by G6PD enzyme
testing at screening.
5. Be an active smoker or user of other forms of tobacco. Former smokers or tobacco
users must have refrained from smoking or using other forms of tobacco for at least 6
months prior to dosing on Study Day 1.
6. A history or clinical manifestations of significant metabolic (including diabetes
mellitus, hypercholesterolemia, or dyslipidemia), hematologic, pulmonary,
cardiovascular, gastrointestinal, neurologic, hepatic, renal, urologic, immunologic,
or psychiatric disorders (a history of mild depression, currently not receiving
therapy, is acceptable).
7. Use any prescription medication within 14 days prior to randomization, or
nonprescription drugs within 7 days. Exceptions may be made by the medical monitor
on a case-by-case basis.
8. Received another investigational drug within 30 days prior to randomization.
9. A positive hepatitis virus test (Hepatitis B virus surface antigen or hepatitis C
virus antibody) or a positive human immunodeficiency virus (HIV) antibody test at
screening. If the HIV test is positive, the subject will be informed privately and
referred for additional counseling.
Locations and Contacts
Jasper Clinic, Kalamazoo, Michigan 49007, United States
Additional Information
Starting date: February 2010
Last updated: June 3, 2014
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