Modulation of Heme Oxygenase 1 by Nizatidine and Lisinopril in Healthy Subjects

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Adil Bharucha
• Collaborators: National Center for Research Resources (NCRR); National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Lisinopril; Nizatidine

Criteria

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.