Safety Evaluation of Aminophylline and Methazolamide

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Brief Title

Safety Evaluation of Aminophylline and Methazolamide

Official Title

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

Brief Summary

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

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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Adverse Events.


Condition

Mountain Sickness

Intervention

Aminophylline

Study Arms / Comparison Groups

 Sequence A
Description:  Aminophylline, Methazolamide, Aminophylline and Methazolamide

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

16

Start Date

December 2011

Completion Date

February 2012

Primary Completion Date

February 2012

Eligibility 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.
      

Gender

All

Ages

18 Years - 40 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Gary Luckasen, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01587027

Organization ID

GQ01 DARPA


Responsible Party

Principal Investigator

Study Sponsor

Poudre Valley Health System

Collaborators

 Defense Advanced Research Projects Agency

Study Sponsor

Gary Luckasen, M.D., Principal Investigator, Poudre Valley Health System


Verification Date

December 2016