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Safety Evaluation of Aminophylline and Methazolamide

Information source: Poudre Valley Health System
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mountain Sickness

Intervention: Aminophylline (Drug); Methazolamide (Drug); Aminophylline and Methazolamide (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Poudre Valley Health System

Official(s) and/or principal investigator(s):
Gary Luckasen, M.D., Principal Investigator, Affiliation: Poudre Valley Health System

Summary

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

Clinical Details

Official title: The Safety Evaluation of Aminophylline and Methazolamide When Administered Orally Alone and in Combination to Healthy Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Adverse Events.

Detailed description: After successful completion of this safety trial, our goal will be to evaluate the safety of this combination in healthy individuals exposed to hypoxia and exercise. Subsequently, an efficacy study will clarify whether this drug combination improves physical and mental functions in human subjects under high altitude conditions.

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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. Exclusion Criteria:

- 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.

Locations and Contacts

Medical Center of the Rockies, Loveland, Colorado 80538, United States
Additional Information

Related Info

Starting date: December 2011
Last updated: May 12, 2014

Page last updated: August 23, 2015

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