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N-acetylcysteine

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01384591Pilot Study of Losartan and N-acetylcysteine as Inhibitors of Muscle Oxidative Stress in ElderlyPHASE1 COMPLETED 6Jul 1, 2011May 1, 2015May 8, 20181 United States
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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 — 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