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Acetazolamide Pill

Phase 1

Hypoxia | Small molecule | Respiratory |United Therapeutics Corporation|Last Updated: Jul 5, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

Acetazolamide Pill · 1 trial · 4 indications

Early Phase 1 1
NCT03525561Acetazolamide and Exercise Performance at AltitudeHypoxia
COMPLETED10 Analytics
EARLY_PHASE1COMPLETED
Acetazolamide and Exercise Performance at Altitude
HypoxiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Endurance exercise performance
Exercise performance will be assessed during a 30-hour simulated altitude exposure, once during placebo and once during acetazolamide administration

the primary outcome measure is performance of a 2-mile treadmill time trial (self-paced) at simulated altitude.

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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
acetazolamide armACTIVE_COMPARATORThis is the arm of the study in which the volunteers will take the acetazolamide (Diamox) pill.
placebo armPLACEBO_COMPARATORThis is the arm of the study in which volunteers will take the placebo.

Interventions

NameTypeDescription
Acetazolamide PillDRUGSubjects will take acetazolamide pill (Diamox), 500 mg/ day, and assess effect on exercise performance during 30-hour exposure to 3,500 m simulated altitude.
Placebo pillDRUGSubjects will take placebo pill and then we will assess exercise performance during 30-hour exposure to 3,500 m simulated altitude.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Volunteers must meet all of the following criteria to be included in the study: * Male or female, age 18-45 * In good health as determined by Office of Medical Support and Oversight (OMSO) General Medical Clearance * Passed his/her most recent Army Physical Fitness Test (APFT; ...

Countries:United States
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Frequently asked questions about Acetazolamide Pill

What is Acetazolamide Pill used for in hypoxia?

Acetazolamide Pill is an investigational small molecule being studied for hypoxia, a condition of insufficient oxygen in the body. It is being developed by United Therapeutics Corporation. The drug is currently in Phase 1 clinical development, meaning it is still being tested in early-stage trials and is not yet approved for any use.

What does Acetazolamide Pill target?

Acetazolamide Pill is a small molecule being developed for hypoxia. The specific molecular target or target class has not been disclosed in available information. The drug is being studied for its effects on exercise performance, cognitive function, and dexterity under hypoxic conditions.

Who makes Acetazolamide Pill?

Acetazolamide Pill is being developed by United Therapeutics Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker UTHR. The company is conducting clinical research on this drug for the treatment of hypoxia.

What phase is Acetazolamide Pill in?

Acetazolamide Pill is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in early-stage trials to evaluate its safety and effects in healthy volunteers.

What clinical trials is Acetazolamide Pill in?

Acetazolamide Pill has one completed clinical trial, NCT03525561, titled 'Acetazolamide and Exercise Performance at Altitude'. This early Phase 1 study enrolled 10 participants in the United States and was placebo-controlled, though not double-blinded. The trial investigated hypoxia, exercise performance, cognitive function, and dexterity.

Is Acetazolamide Pill the same as acetazolamide?

Acetazolamide Pill is a formulation of acetazolamide, a well-known carbonic anhydrase inhibitor. However, the specific brand name or alternative names for this investigational product have not been provided. The drug is being developed by United Therapeutics for hypoxia and is currently in Phase 1 trials.