Safety Study of RP-1127 (Glyburide for Injection) in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Remedy Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01132703
First received: April 14, 2010
Last updated: June 3, 2014
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Traumatic Brain Injury
Stroke
Drug: RP-1127 (Glyburide for injection)
Drug: Placebo (RP-1127 excipients, excluding active)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Remedy Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]
    In particular, events of hypoglycemia and EKG changes will be studied


Enrollment: 34
Study Start Date: February 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RP-1127 (Glyburide for Injection) Drug: RP-1127 (Glyburide for injection)
RP-1127 is administered as a bolus followed by continuous infusion for 72 hours
Placebo Comparator: Placebo
Placebo (RP-1127 excipients without active)
Drug: Placebo (RP-1127 excipients, excluding active)
RP-1127 excipients, excluding active

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01132703

Locations
United States, Michigan
Jasper Clinic
Kalamazoo, Michigan, United States, 49007
Sponsors and Collaborators
Remedy Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Remedy Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01132703     History of Changes
Other Study ID Numbers: RPI 101
Study First Received: April 14, 2010
Last Updated: June 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Glyburide
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014