Safety Evaluation of Aminophylline and Methazolamide

NCT01587027 | Completed Phase 1 Results DMC

• 1 other identifier: GQ01 DARPA
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mountain Sickness

Keywords

Altitude Sickness; High Altitude Sickness

Outcome Measures

Primary Outcomes (1)

• Adverse Events.

  Adverse event data was evaluated for incidence and severity for 6 days.

  6 days.

Study Arms (2)

Sequence A

ACTIVE COMPARATOR

Aminophylline, Methazolamide, Aminophylline and Methazolamide

Drug: Aminophylline; Drug: Methazolamide; Drug: Aminophylline and Methazolamide

Sequence B

ACTIVE COMPARATOR

Methazolamide, Aminophylline, Aminophylline and Mathazolamide

Drug: Aminophylline; Drug: Methazolamide; Drug: Aminophylline and Methazolamide

Interventions

Aminophylline DRUG

Aminophylline dosage form-tablet dosage-500mg

Also known as: theophylline

Sequence A; Sequence B

Methazolamide DRUG

Methazolamide dosage form-tablet dosage-250mg

Also known as: Neptazane

Sequence A; Sequence B

Aminophylline and Methazolamide DRUG

Aminophylline 500mg orally and Methazolamide 250mg orally

Also known as: theophylline, Neptazane

Sequence A; Sequence B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poudre Valley Health System: lead
• Defense Advanced Research Projects Agency: collaborator
• University of Colorado, Denver: collaborator

Study Sites (1)

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Altitude Sickness

Interventions

Aminophylline; Theophylline; Methazolamide

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Alkaloids; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Gary Luckasen, M.D.
• Organization: Medical Center of the Rockies

gary.luckasen@uchealth.org

(970)624-1686

Study Officials

• Gary Luckasen, M.D.

  Poudre Valley Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: April 16, 2012
• First Posted: April 27, 2012
• Study Start: December 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 10, 2017
• Results First Posted: June 9, 2014

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)