Safety Evaluation of Aminophylline and Methazolamide

Completed · Phase 1

Conditions studied: Mountain Sickness

In brief

This safety study is the first in a series of studies testing the application of the combination of aminophylline and methazolamide.

Key facts

Study ID

NCT01587027

Run by

Poudre Valley Health System

People needed

16

Starts

2011-12-01

Expected to finish

2012-02-01

Last updated by the study team

2017-02-10

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects must be healthy non-smoking adult male and female volunteers between the ages of 18 and 40 years, with a BMI of 18-30 kg/m2 and weighting at least 150 lbs. Women who are of childbearing potential, must, if sexually active, must agree to use appropriate contraceptive measures for the duration of the study and for one (1) month afterwards.
• Subjects must agree not to donate blood, plasma, platelets, or any other blood components during the study and for 4 weeks after the last dose.

You may not qualify if…

• History or manifestation of clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematologic or other medical disorders.
• Serious mental or physical illness within the past year.
• History of clinically significant illness within 4 weeks prior to Day 1.
• History of allergic reaction, hypersensitivity or idiosyncratic reaction to any of the products administered during the study, including allergy to any sulfa or sulfonamide derivatives.
• Use of any of the following:
• Any concomitant medication. Subjects who have received any prescribed or non-prescribed (over-the-counter [OTC]) systemic medication, topical medications, or herbal supplements within 14 days from Day 1. St. John's Wort (hypericin) must not have been taken for at least 30 days prior to Period 1, Day 1.
• Any drugs, foods or substances known to be strong inhibitors or strong inducers of CYP enzymes (also known as cytochrome P450 enzymes); especially CYP 1A2, or Pgp within 30 days prior to Period 1, Day 1.
• Currently abusing drugs or alcohol or with a history of drug or alcohol abuse within the past two years.
• Positive results on screening tests for drugs of abuse, cotinine or alcohol at screening or the pre-dose assessment at check-in.
• Clinically significant ECG abnormality, in the opinion of the Investigator.
• Use of tobacco products or other nicotine-containing products (including smoking cessation aids, such as gums or patches) with in 14 days of screening and throughout hospitalization.
• Subjects of childbearing potential who are pregnant (as based on test results) or are breast feeding.
• Has taken any other investigational drug during the 30 days prior to the screening visit or is currently participating in another investigational clinical trial.
• Subjects who have made any significant donation (including plasma) or have had a significant loss of blood within 30 days prior to Period 1, Day 1.
• Receipt of a transfusion or any blood products within 30 days prior to Period 1, Day 1.

Where it is running

• Medical Center of the Rockies — Loveland, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.