Brief Summary

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

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

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Study Primary Completion Date: February 2012

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

• Drug: Treatment 1
  • Aminophylline dosage form-tablet dosage-500mg
• Drug: Treatment 2
  • Methazolamide dosage form-tablet dosage-250mg
• Drug: Treatment 3
  • Aminophylline 500mg orally and Methazolamide 250mg orally

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Sequence A
  • Treatment 1, Treatment 2, Treatment 3
• Active Comparator: Sequence B
  • Treatment 2, Treatment 1, Treatment 3

Outcome Measures for this Clinical Trial

Primary Measures

• Adverse Events, including clinically significant laboratory and other relevant results and findings.
  • Time Frame: 6 days.
    Safety Issue?: Yes

Secondary Measures

• Pharmacokinetic profile of aminophylline.
  • Time Frame: Day 1, 3 and 5.
    Safety Issue?: Yes
• Pharmacokinetic profile of methazolamide.
  • Time Frame: Days 1, 3, and 5.
    Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

• Lead Sponsor
  • Poudre Valley Health System
• Collaborator
  • Defense Advanced Research Projects Agency
• Provider of Information About this Clinical Study
  • Principal Investigator: Gary J. Luckasen, MD, Prinicipal Investigator - Poudre Valley Health System
• Overall Official(s)
  • Gary Luckasen, M.D., Principal Investigator, Poudre Valley Health System