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AZD3241 formulation 1

Phase 1

Parkinson's Disease | Small molecule | Neurology |AstraZeneca PLC|Last Updated: Aug 17, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

AZD3241 formulation 1 · 1 trial · 1 indication

Phase 1 1
NCT01457807To Assess the Effect of Administration of 2 Formulation of AZD3241 on Blood Concentration in Healthy VolunteersParkinson's Disease
COMPLETED24 Analytics
PHASE1COMPLETED
To Assess the Effect of Administration of 2 Formulation of AZD3241 on Blood Concentration in Healthy Volunteers
Parkinson's Disease
NCT0145780724
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Study Endpoints

Primary Endpoints

AUC(0-12),ss: Area under the plasma concentration-time curve from time zero to the end of the 12-hour dosing interval at steady state.
Day 1 until 24 hours post last dose (administered on the morning of Day 8)
AUC(0-12),ss/DN: Area under the plasma concentration-time curve from time zero to the end of the 12-hour dosing interval at steady state observed with the 300 mg ER formulations normalised to a 100 mg dose of AZD3241
Day 1 until 24 hours post last dose (administered on the morning of Day 8)
Css,max: Observed maximum plasma concentration at steady state.Css,max/DN Observed maximum plasma concentration at steady state observed with the 300 mg ER formulations normalised to a 100 mg dose of AZD3241.
Day 1 until 24 hours post last dose (administered on the morning of Day 8)
Css,min: Observed minimum plasma concentration at steady state.Css,min/DN Observed minimum plasma concentration at steady state observed with the 300 mg ER formulations normalised to a 100 mg dose of AZD3241.
Day 1 until 24 hours post last dose (administered on the morning of Day 8)
Css,av: Average plasma concentration during the 12-hour dosing interval at steady state calculated as follows: AUC(0-12),ss/12 h.
Day 1 until 24 hours post last dose (administered on the morning of Day 8)
Description of fluctuation at steady-state [(Css,max-Css,min)/Css,av]
Day 1 until 24 hours post last dose (administered on the morning of Day 8)
AUC(0-t),ss: Area under the plasma concentration-time curve from time zero to the last quantifiable time point.
Day 1 until 24 hours post last dose (administered on the morning of Day 8)
λz,ss: Terminal elimination rate constant at steady state.
Day 1 until 24 hours post last dose (administered on the morning of Day 8)
t½λz,ss: Half-life of terminal elimination phase at steady state.
Day 1 until 24 hours post last dose (administered on the morning of Day 8)

Secondary Endpoints

Description of the safety and tolerability profile in terms of Adverse Events of 8 days of administration of AZD3241, up to steady state (300 mg twice daily), of 2 new, different extended release tablets of AZD3241 (300 mg), including initial titration.
Day 1 to Day 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
1EXPERIMENTALAZD3241 300mg extended release formulation 1
2EXPERIMENTALAZD3241 300mg extended release formulation 2
3PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
AZD3241 ER formulation 1DRUGOral tablets, 100mg bd on Day 1 to Day 2, 200mg bd on Day3, 300mg bd on Day 4 to Day7 and 300mg Once daily on Day 8 with High Fat Breakfast
PlaceboDRUGPlacebo will be administered with the same intervention scheme as intervention 1 and 2
AZD3241 Alternative titration scheme with formulation 1 or 2DRUG50 mg oral dose bd on Day 1, 100 mg oral dose bd on Day 2 and 3, 200 mg oral dose bd on Day 4, 300 mg oral dose bd on Day 5 to 7 and 300 mg once in the morning on Day 8
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Eligibility Criteria

Age Range30 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures * Healthy male or female volunteers aged 30 to 65 years, inclusive, with suitable veins for cannulation or repeated venepuncture * Female volunteers must have a negative pregnancy te...

Countries:United Kingdom
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Competitive Landscape -Parkinson's Disease 58 trials

CompanyTickerTrialsLead PhaseDrugs
Supernus Pharmaceuticals, Inc.SUPN2PHASE3apomorphine infusion
Prothena Corp. PlcPRTA3PHASE3Prasinezumab
Biohaven Ltd.BHVN1PHASE2BHV-8000
Denali Therapeutics Inc.DNLI1PHASE2BIIB122
AC Immune SAACIU2PHASE2ACI-7104.056 at Dose A, ACI-7104.056 at Dose B, ACI-7104.056 at Dose C
Gain Therapeutics, Inc.GANX2PHASE2Low Dose GT-02287
Eli Lilly and CompanyLLY3PHASE1LY3884961, Methylprednisolone, Sirolimus
Annovis Bio IncANVS1PHASE2buntanetap/posiphen
Regeneron Pharmaceuticals, Inc.REGN2PHASE1ALN-SNCA
QIAGEN NVQGEN1PHASE2NEU-411
AbbVie, Inc.ABBV9 - Undisclosed
Illumina, Inc.ILMN1PHASE218F-MFBG
MeiraGTx Holdings PlcMGTX1PHASE1AAV-GAD
Masimo CorporationMASI1PHASE1Diprivan, Astra-Zeneca
Boston Scientific CorporationBSX3 - Undisclosed
AgeX Therapeutics, Inc.SER1PHASE1SER-252
Abbott LaboratoriesABT2N/AUndisclosed
Ardelyx, Inc.ARDX1PHASE2Tenapanor
Novo Nordisk A/S Sponsored ADR Class BNVO1 - Undisclosed
Sage BionetworksSAGE1N/AUndisclosed
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Frequently asked questions about AZD3241 formulation 1

What is AZD3241 formulation 1 used for?

AZD3241 formulation 1 is an investigational small molecule being studied for Parkinson's Disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its safety and pharmacokinetic profile in clinical trials.

Who makes AZD3241 formulation 1?

AZD3241 formulation 1 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's safety and tolerability in healthy volunteers.

What phase is AZD3241 formulation 1 in?

AZD3241 formulation 1 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 trial has been completed, and the drug remains under investigation for Parkinson's Disease.

What clinical trials is AZD3241 formulation 1 in?

AZD3241 formulation 1 has one completed Phase 1 clinical trial with the identifier NCT01457807. This trial assessed the effect of two formulations of AZD3241 on blood concentration in healthy volunteers in the United Kingdom. The study enrolled 24 participants and was randomized, double-blind, and placebo-controlled.

Is AZD3241 formulation 1 the same as AZD3241?

AZD3241 formulation 1 is one of two formulations of the drug AZD3241 evaluated in a clinical trial. The study NCT01457807 compared two formulations of AZD3241 to assess their effects on blood concentration. Both formulations are being developed by AstraZeneca for Parkinson's Disease.