Safety Evaluation of Aminophylline and Methazolamide

This study has been completed.
Sponsor:
Collaborators:
Defense Advanced Research Projects Agency
University of Colorado, Denver
Information provided by (Responsible Party):
Gary J. Luckasen, MD, Poudre Valley Health System
ClinicalTrials.gov Identifier:
NCT01587027
First received: April 16, 2012
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Mountain Sickness
Drug: Aminophylline
Drug: Methazolamide
Drug: Aminophylline and Methazolamide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Safety Evaluation of Aminophylline and Methazolamide When Administered Orally Alone and in Combination to Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Poudre Valley Health System:

Primary Outcome Measures:
  • Adverse Events. [ Time Frame: 6 days. ] [ Designated as safety issue: Yes ]
    Adverse event data was evaluated for incidence and severity for 6 days.


Enrollment: 16
Study Start Date: December 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sequence A
Aminophylline, Methazolamide, Aminophylline and Methazolamide
Drug: Aminophylline
Aminophylline dosage form-tablet dosage-500mg
Other Name: theophylline
Drug: Methazolamide
Methazolamide dosage form-tablet dosage-250mg
Other Name: Neptazane
Drug: Aminophylline and Methazolamide
Aminophylline 500mg orally and Methazolamide 250mg orally
Other Names:
  • theophylline
  • Neptazane
Active Comparator: Sequence B
Methazolamide, Aminophylline, Aminophylline and Mathazolamide
Drug: Aminophylline
Aminophylline dosage form-tablet dosage-500mg
Other Name: theophylline
Drug: Methazolamide
Methazolamide dosage form-tablet dosage-250mg
Other Name: Neptazane
Drug: Aminophylline and Methazolamide
Aminophylline 500mg orally and Methazolamide 250mg orally
Other Names:
  • theophylline
  • Neptazane

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01587027

Locations
United States, Colorado
Medical Center of the Rockies
Loveland, Colorado, United States, 80538
Sponsors and Collaborators
Poudre Valley Health System
Defense Advanced Research Projects Agency
University of Colorado, Denver
Investigators
Principal Investigator: Gary Luckasen, M.D. Poudre Valley Health System
  More Information

Additional Information:
No publications provided

Responsible Party: Gary J. Luckasen, MD, Prinicipal Investigator, Poudre Valley Health System
ClinicalTrials.gov Identifier: NCT01587027     History of Changes
Other Study ID Numbers: GQ01 DARPA
Study First Received: April 16, 2012
Results First Received: August 7, 2013
Last Updated: May 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Poudre Valley Health System:
Altitude Sickness
High Altitude Sickness

Additional relevant MeSH terms:
Altitude Sickness
Respiration Disorders
Respiratory Tract Diseases
Theophylline
Aminophylline
Methazolamide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Cardiovascular Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Cardiotonic Agents
Protective Agents
Carbonic Anhydrase Inhibitors
Diuretics
Natriuretic Agents

ClinicalTrials.gov processed this record on September 18, 2014