The Effect of Cinacalcet on Gastric Acid Output in Healthy Subjects

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether cinacalcet will increase gastric acid secretion in healthy volunteers.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tufts University
• Treatments: Cinacalcet; Cinacalcet Hydrochloride

Criteria

Inclusion Criteria:

• Healthy ambulatory men and postmenopausal women

• Age 45 to 70

• Avoid alcohol, antacids, H2 blockers, proton pump inhibitors, or antihistamines during the study.

Exclusion Criteria:

• Ionized Ca++ level <4.39 mg/dl or >5.02 mg/dl (normal reference range 4.18- 5.02).

• 24-hour UCa++ excretion >350 mg.

• Cr >1.3.

• AST/ALT values >10% beyond reference range.

• Hgb level <11.7 g/dl in women and <13.2 g/dl in men.

• MCV level >102 UM3.

• Basal acid output >5 mEq/h in men and >3.8 mEq/h in women.

• Basal acid output <1 mEq/h in men and <0.2 mEq/h in women.

• Age <45 or >70.

• Premenopausal or <1 year post-menopause.

• Individuals following vegan diets.

• Current EtOH abuse.

• Lidocaine allergy. Medications

• Antacids

• H2 blockers

• Proton pump inhibitors

• Carafate

• Anticholinergic agents (i.e. TCA)

• Cholinergic agents

• Antihistamines in the last 3 weeks

• Cogentin

• Adrenergic blockers

• Thiazide diuretics

• Antiplatelet drugs

• Oral and Inhaled Glucocorticoids

• Bisphosphonates

• Raloxifene, Tamoxifen

• Tobacco

• EtOH during study

• rPTH

• Calcitonin

• Ketoconazole/Itraconazole

• Calcitriol

• Paricalcitol

• Drisdol, Ergocalciferol

• Phosphate binders

• Anticoagulant

• Erythromycin

• Hormone replacement therapy except vaginal estrogen creams

Exclusion Diseases

• Achlorhydria

• Pernicious anemia

• Zollinger Ellison syndrome

• Congestive heart failure

• Esophageal strictures or motility problems

• History of a GI bleed

• Prior upper GI surgery

• Malabsorption

• History of GI malignancy

• GERD, gastritis, duodenitis

• Active peptic ulcer disease

• Gallbladder disease

• Liver disease

• Pancreatitis

• Current kidney stone

• Renal disease

• Current hypoparathyroidism or hyperparathyroidism

• Moderate to Severe coronary artery disease

• Aortic aneurysm

• Seizure disorder

• Current Arrhythmia