Safety Study of RMJH-111b to Treat Essential Hypertension

• Status: Completed
• Trial end date: 2016-07-07
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to evaluate the safety of RMJH-111b, including how well it is tolerated, and the effect of RMJH-111b on blood pressure in subjects with hypertension. The study also measured the amount of magnesium in the blood and urine before and after RMJH-111b administration to evaluate what the body does to RMJH-111b (pharmacokinetics).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RMJ Holdings, LLC
• Treatments: Citric Acid; Magnesium citrate

Criteria

Inclusion Criteria:

• Male or female, 18-80 years old

• Diagnosed with essential hypertension

• SBP ≥ 150 & ≤ 200 mmHg & DBP ≥ 95 and ≤ 115 mmHg after resting for 5 minutes in the seated position at Day 1 & baseline (pre-dose Day 4)

• Both males & women of child bearing potential (WCBP) agree to use adequate contraceptive methods while on study

• Willing and able to sign informed consent form (ICF)

• Suitable for participation in the study in the opinion of the Investigator

Exclusion Criteria:

• History of myocardial infarction, congestive heart failure, or stroke within 6 months of Screening, or evidence of greater than 1st degree heart block or myocardial damage

• History of chronic hepatitis

• Uncontrolled diabetes (hemoglobin A1C ≥ 6.5%) at Screening or Day 1

• Glomerular filtration rate < 60 mL/min at Screening or Day 1

• Serum hypo- or hyper-natremia (≤ 133 & ≥145 meq/L) at Screening or Day 1

• Low serum potassium (≤ 3.3 meq/L) at Screening or Day 1

• Low total serum magnesium (≤ 1.3 mg/dL) or total serum magnesium greater than the upper limit of normal (2.5 mg/dL) at Screening or Day 1

• Serum uric acid > 6.5 mg/dL for females or >7.5 mg/dL for males at Screening or Day 1

• Absence of patellar reflex (knee jerk) at Day 1-3, or pre-dose Day 4

• Evidence of clinically significant findings at Screening, during the run-in period (Days 1-3), or at baseline (pre-dose Day 4) which, in the opinion of the Investigator would pose a safety risk or interfere with appropriate interpretation of safety data

• Malignancy within 5 years of the Screening Visit (with the exception of basal cell and squamous cell skin carcinoma)

• Major surgery within four weeks prior to Screening

• Presence of a malabsorption syndrome possibly affecting drug absorption (e.g., Crohn's disease or chronic pancreatitis)

• Presence of irritable bowel syndrome, ulcerative colitis, or chronic diarrhea

• History of psychotic disorder

• History of alcoholism or drug addiction or current alcohol or drug use that, in the opinion of the Investigator, will interfere with the subject's ability to comply with the dosing schedule & study evaluations

• History of any illicit drug use within one year prior to Screening

• Positive drug screen at Screening or at Day 1, except subjects on prescription drugs that in the opinion of the Investigator will not influence the outcome of the study

• Positive breathalyzer test for blood alcohol content at Screening or at Day 1

• Consumption of more than five cups of caffeinated beverages per day

• Current treatment or treatment within 30 days prior to the first dose of Study Drug (active or placebo; Day 4) with another investigational drug, or current enrollment in another clinical trial

• Current treatment or treatment within 10 days prior to the first dose of Study Drug (active or placebo; Day 4) with any anti-hypertension medication (other than Study Drug during the treatment period)

• Current treatment or treatment within 30 days prior to the first dose of Study Drug (active or placebo; Day 4) with magnesium-containing antacids or laxatives, dietary supplement(s) where the total daily dose of magnesium is greater than 150 mg, central nervous system depressants, neuromuscular blocking agents, or cardiac glycosides, lithium-containing drugs, bisphosphonates, sodium polystyrene sulfonate, or tetracycline/quinolone antibiotics, anti-tumor necrosis factor-alpha drugs, or phytotherapeutic/herbal/ plant derived preparations

• Known hypersensitivity to magnesium

• Known hypersensitivity to the inactive ingredients in the Study Drug (placebo and active)

• Positive pregnancy test at Screening or at Day 1, or lactating

• Arm circumference greater than 42 centimeters