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N-acetylcysteine

Phase 1

Aging | Small molecule | Other |Lantheus Holdings, Inc.|Last Updated: May 8, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

N-acetylcysteine · 1 trial · 1 indication

Phase 1 1
NCT01384591Pilot Study of Losartan and N-acetylcysteine as Inhibitors of Muscle Oxidative Stress in ElderlyAging
COMPLETED6 Analytics
PHASE1COMPLETED
Pilot Study of Losartan and N-acetylcysteine as Inhibitors of Muscle Oxidative Stress in Elderly
Aging
NCT013845916
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Study Endpoints

Primary Endpoints

Leg Blood Flow as Measured by Doppler Ultrasound
Baseline

Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.

Secondary Endpoints

Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline
baseline
Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline
baseline
Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at Baseline
baseline
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Losartan and placebo N-acetylcysteineEXPERIMENTALlosartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartan and placebo N-acetylcysteinePLACEBO_COMPARATORPlacebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2.
N-acetylcysteine and placebo losartanEXPERIMENTALN-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.

Interventions

NameTypeDescription
N-acetylcysteineDRUG50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
LosartanDRUG25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo losartanDRUGPlacebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
Placebo N-acetylcysteineDRUGPlacebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
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Eligibility Criteria

Age Range60 Years to 85 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age between 60-85 years. 2. Ability to sign informed consent. 3. Ability to sign consent form. 4. Ability to pass a mini-mental status exam (score \>23 on the 30-item Mini Mental State Examination, MMSE). 5. Free-living, prior to admission. Exclusion Criteria: 1. Subjects w...

Countries:United States
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Competitive Landscape -Cardiac Imaging 3 trials (matched to "Aging")

CompanyTickerTrialsLead PhaseDrugs
Boston Scientific CorporationBSX1N/AUndisclosed
HeartFlow, Inc.HTFL1N/ARosuvastatin
Ultragenyx Pharmaceutical, Inc.RARE1 - Undisclosed
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Frequently asked questions about N-acetylcysteine

What is N-acetylcysteine used for in aging?

N-acetylcysteine is being studied for use in aging, specifically as an inhibitor of muscle oxidative stress in elderly individuals. It is an investigational small molecule currently in Phase 1 clinical development. The drug is being evaluated in a pilot study to assess its potential effects on age-related muscle oxidative stress.

What does N-acetylcysteine target?

N-acetylcysteine targets muscle oxidative stress, which is associated with the aging process. The drug is being investigated for its ability to inhibit oxidative stress in muscle tissue of elderly individuals. This mechanism is the focus of the ongoing clinical research into its potential use in aging-related conditions.

Who makes N-acetylcysteine?

N-acetylcysteine is being developed by Lantheus Holdings, Inc., a company traded on the stock exchange under the ticker symbol LNTH. The company is conducting clinical research on this drug for its potential application in aging, specifically targeting muscle oxidative stress in the elderly population.

What phase is N-acetylcysteine in?

N-acetylcysteine is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is currently being studied in a Phase 1 pilot trial to evaluate its safety and potential efficacy in addressing muscle oxidative stress associated with aging.

What clinical trials is N-acetylcysteine in?

N-acetylcysteine is being studied in clinical trial NCT01384591, titled "Pilot Study of Losartan and N-acetylcysteine as Inhibitors of Muscle Oxidative Stress in Elderly." This Phase 1 trial has been completed and enrolled 6 participants in the United States. The study was randomized, double-blind, and placebo-controlled, and included healthy volunteers aged 60 years and older.

Is N-acetylcysteine the same as NAC?

N-acetylcysteine is commonly known by the abbreviation NAC. The drug is being developed by Lantheus Holdings, Inc. for potential use in aging-related conditions, specifically targeting muscle oxidative stress. It is currently in Phase 1 clinical development and remains an investigational compound.