Safety Evaluation of Aminophylline and Methazolamide

Phase 1

Completed

• Conditions: Mountain Sickness
• Interventions: Drug: Aminophylline; Drug: Methazolamide; Drug: Aminophylline and Methazolamide

• Registration Number: NCT01587027
• Lead Sponsor: Poudre Valley Health System

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 Timeline

• Study Start: 2011-12
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2012-04-16
• Study First Submitted QC: 2012-04-26
• Study First Posted: 2012-04-27
• Results First Submitted: 2013-08-07
• Results First Submitted QC: 2014-05-12
• Results First Posted: 2014-06-09
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-22
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A	Aminophylline and Methazolamide	Aminophylline, Methazolamide, Aminophylline and Methazolamide
Sequence B	Aminophylline and Methazolamide	Methazolamide, Aminophylline, Aminophylline and Mathazolamide
Sequence A	Aminophylline	Aminophylline, Methazolamide, Aminophylline and Methazolamide
Sequence A	Methazolamide	Aminophylline, Methazolamide, Aminophylline and Methazolamide
Sequence B	Aminophylline	Methazolamide, Aminophylline, Aminophylline and Mathazolamide
Sequence B	Methazolamide	Methazolamide, Aminophylline, Aminophylline and Mathazolamide

Primary Outcome Measures

Name	Time	Method
Adverse Events.	6 days.	Adverse event data was evaluated for incidence and severity for 6 days.

Trial Locations

Locations (1)

Medical Center of the Rockies; 🇺🇸 Loveland, Colorado, United States