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N-acetylcysteine

Phase 1

Drug-Induced Acute Liver Injury | Small molecule | Gastrointestinal |Novo Nordisk A/S|Last Updated: Sep 24, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

N-acetylcysteine · 1 trial · 1 indication

Phase 1 1
NCT03679442Macrophage Markers, Soluble CD163 (sCD163) and Soluble CD206 (sCD206) in Paracetamol OverdoseDrug-Induced Acute Liver Injury
COMPLETED16 Analytics
PHASE1COMPLETED
Macrophage Markers, Soluble CD163 (sCD163) and Soluble CD206 (sCD206) in Paracetamol Overdose
Drug-Induced Acute Liver Injury
NCT0367944216
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Study Endpoints

Primary Endpoints

Change from baseline in sCD163
16 hours

Change in macrophage activation marker soluble CD163 after treatment of healthy individuals with N-acetylcysteine

Change from baseline in sCD206
16 hours

Change in macrophage activation marker soluble CD206 after treatment of healthy individuals with N-acetylcysteine

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Healthy individualsEXPERIMENTALHealthy individuals received intravenous N-acetylcysteine (NAC) treatment to investigate its actions on macrophage activation assessed by the markers soluble CD163 and CD206

Interventions

NameTypeDescription
N-acetylcysteineDRUGNon-randomized exposure to N-acetylcysteine (NAC) of healthy individuals corresponding to the clinical treatment guidelines for paracetamol-overdosed patients
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Age 18 to 75 Exclusion Criteria: * A history of previous illness

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Frequently asked questions about N-acetylcysteine

What is N-acetylcysteine used for in drug-induced acute liver injury?

N-acetylcysteine is being studied for drug-induced acute liver injury, a condition where the liver is damaged by medications. It is currently in Phase 1 clinical development as an investigational small molecule therapy. The drug is being evaluated for its potential to address this serious gastrointestinal condition.

What does N-acetylcysteine target?

N-acetylcysteine is being studied for its effects on macrophage markers, specifically soluble CD163 (sCD163) and soluble CD206 (sCD206), in the context of paracetamol overdose. These markers are associated with macrophage activation and may play a role in drug-induced acute liver injury.

Who makes N-acetylcysteine?

N-acetylcysteine is being developed by Novo Nordisk A/S, a biopharmaceutical company listed on the stock exchange under the ticker symbol NVO. The company is conducting clinical research to evaluate the drug's potential in treating drug-induced acute liver injury.

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 being studied for its safety and potential efficacy in patients with drug-induced acute liver injury.

What clinical trials is N-acetylcysteine in?

N-acetylcysteine is associated with one completed clinical trial, NCT03679442, titled 'Macrophage Markers, Soluble CD163 (sCD163) and Soluble CD206 (sCD206) in Paracetamol Overdose.' This Phase 1 study enrolled 16 participants and was an uncontrolled, non-randomized trial that included healthy volunteers.

Is N-acetylcysteine the same as other forms of acetylcysteine?

N-acetylcysteine is a specific form of acetylcysteine being investigated by Novo Nordisk for drug-induced acute liver injury. While acetylcysteine is a known compound, this particular development program focuses on its use in this indication and is currently in early-stage clinical research.