- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01587027
Safety Evaluation of Aminophylline and Methazolamide
December 22, 2016 updated by: Gary J. Luckasen, MD, Poudre Valley Health System
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Loveland, Colorado, United States, 80538
- Medical Center of the Rockies
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Sequence A
Aminophylline, Methazolamide, Aminophylline and Methazolamide
|
Aminophylline dosage form-tablet dosage-500mg
Other Names:
Methazolamide dosage form-tablet dosage-250mg
Other Names:
Aminophylline 500mg orally and Methazolamide 250mg orally
Other Names:
|
Active Comparator: Sequence B
Methazolamide, Aminophylline, Aminophylline and Mathazolamide
|
Aminophylline dosage form-tablet dosage-500mg
Other Names:
Methazolamide dosage form-tablet dosage-250mg
Other Names:
Aminophylline 500mg orally and Methazolamide 250mg orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events.
Time Frame: 6 days.
|
Adverse event data was evaluated for incidence and severity for 6 days.
|
6 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gary Luckasen, M.D., Poudre Valley Health System
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
April 16, 2012
First Submitted That Met QC Criteria
April 26, 2012
First Posted (Estimate)
April 27, 2012
Study Record Updates
Last Update Posted (Actual)
February 10, 2017
Last Update Submitted That Met QC Criteria
December 22, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Respiration Disorders
- Altitude Sickness
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Purinergic Antagonists
- Purinergic Agents
- Protective Agents
- Carbonic Anhydrase Inhibitors
- Natriuretic Agents
- Cardiotonic Agents
- Diuretics
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Phosphodiesterase Inhibitors
- Purinergic P1 Receptor Antagonists
- Theophylline
- Aminophylline
- Methazolamide
Other Study ID Numbers
- GQ01 DARPA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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