Status:
COMPLETED
Modulation of Heme Oxygenase 1 by Nizatidine and Lisinopril in Healthy Subjects
Lead Sponsor:
Adil Bharucha
Collaborating Sponsors:
National Center for Research Resources (NCRR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Gastroparesis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
To assess if oral nizatidine or lisinopril alone and in combination will increase heme oxygenase 1 (HO-1) protein concentration and activity compared to placebo in healthy subjects.
Detailed Description
Current therapeutic options for gastroparesis are limited to dietary modifications and pharmacological (i.e., prokinetic and symptomatic) agents. Exciting and novel preliminary data from our programs ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy subjects without clinical evidence of significant cardiovascular, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns
- Normal serum potassium and estimated glomerular filtration rate (eGFR) \> 60 ml/minute
- Baseline systolic BP ≥ 110 mmHg
- No known hypersensitivity to lisinopril or nizatidine
- Able to provide written informed consent before participating in the study
- Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
- Exclusion criteria:
- Pregnant
- Breast feeding
- Current smoker
- Symptoms of functional GI disorder as assessed by a validated questionnaire
- Previous history of peptic ulcer disease.
Exclusion
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02232308
Start Date
July 1 2014
End Date
September 1 2014
Last Update
April 30 2015
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
2
Mayo Clinic
Rochester, Minnesota, United States, 55905