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AZD4451

Phase 1

Bipolar Disorder | Small molecule | Psychiatry |AstraZeneca PLC|Last Updated: Aug 1, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment63

FDA Designations

No designations recorded

Clinical trial landscape

AZD4451 · 1 trial · 1 indication

Phase 1 1
NCT01196676Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4451Bipolar Disorder
COMPLETED63 Analytics
PHASE1COMPLETED
Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4451
Bipolar Disorder
NCT0119667663
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Study Endpoints

Primary Endpoints

To assess the safety and tolerability of single ascending oral doses of AZD4451 by assessing AEs, vital signs, physical examinations, neurological examinations clinical laboratory parameters, Columbia Suicide Severity Rating Scale(CSSRS), EEGs and ECGs
Screening to end of study.

Secondary Endpoints

To assess the pharmacokinetics of single ascending oral doses of AZD4451 by maximum plasma concentration (Cmax).
Predose, 30 min, 1 hr, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 18, 24, 30, 48, and 72 hours postdose.
To evaluate and characterize the PK of AZD4451 and its metabolites AZ13263197 and AZ13263195 when given orally in single ascending doses by assessment of drug concentration in urine.
Urine will be collectioned for 72 hours post-dose. Pre-dose to 12 hours, 12-24, 24- 48 and 48-72 hours post-dose.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
1EXPERIMENTALAZD4451
2PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
AZD4451DRUG1 mg capsules, 5 mg capsules, and 25 mg capsules
PlaceboDRUG1 mg capsules, 5 mg capsules, and 25 mg capsules
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provide a signed and dated, written informed consent prior to any study specific procedures being performed. including the genetic sampling and analyses. If a volunteer declines to participate in the genetic component of the study, there will be no penalty or loss of benefit t...

Countries:United States
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Competitive Landscape -Bipolar Disorder 20 trials

CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY4PHASE3KarXT
AbbVie, Inc.ABBV3PHASE3Cariprazine
Alkermes Public Limited CompanyALKS2PHASE3OLZ/SAM
Xenon Pharmaceuticals Inc.XENE2PHASE3Azetukalner
Eli Lilly and CompanyLLY1PHASE2Brenipatide
Rapport Therapeutics, Inc.RAPP1PHASE2RAP-219
Neurocrine Biosciences, Inc.NBIX1PHASE2NBI-1117568
Alto Neuroscience, Inc.ANRO1PHASE2ALTO-100
LB Pharmaceuticals, Inc.LBRX1PHASE2LB-102
BioXcel Therapeutics, Inc.BTAI1PHASE1BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
Alzamend Neuro, Inc.ALZN1PHASE1AL001, Lithium carbonate
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Frequently asked questions about AZD4451

What is AZD4451 used for?

AZD4451 is an investigational small molecule being developed for the treatment of bipolar disorder. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied to assess its safety, tolerability, and pharmacokinetics in clinical trials.

Who makes AZD4451?

AZD4451 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's safety and tolerability in patients with bipolar disorder.

What phase is AZD4451 in?

AZD4451 is currently in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing for the treatment of bipolar disorder.

What clinical trials is AZD4451 in?

AZD4451 has been studied in one clinical trial with the identifier NCT01196676. This was a Phase 1 single ascending dose study that assessed the safety, tolerability, and pharmacokinetics of the drug. The trial was completed and enrolled 63 participants in the United States.

Is AZD4451 FDA approved?

AZD4451 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for bipolar disorder. The completed Phase 1 trial focused on safety, tolerability, and pharmacokinetics, but the drug has not yet progressed to later-stage trials or received marketing approval.