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PF-00217830

Phase 2

Schizophrenia | Small molecule | Psychiatry |Pfizer, Inc.|Trials Updated: Apr 18, 2012

PF-00217830 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Dec 2007

PF-00217830 target and mechanism

Molecular targetDRD2
Target classPartial Agonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment164

FDA Designations

No designations recorded

PF-00217830 clinical trials

PF-00217830 · 1 trial · 1 indication

Phase 2 1
NCT00580125Dose-response Study to Evaluate Safety, Efficacy, and Pharmacokinetics of PF-00217830 Compared With Placebo in Acute Exacerbation of SchizophreniaSchizophrenia
COMPLETED164 Analytics
PHASE2COMPLETED
Dose-response Study to Evaluate Safety, Efficacy, and Pharmacokinetics of PF-00217830 Compared With Placebo in Acute Exacerbation of Schizophrenia
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical laboratory (Screening, Days 1, 7, 14, 21 and Followup); Fasting insulin, HDL, LDL, HbA1c , prolactin, ACTH, and cortisol (Days 1 and 21).
5 weeks
Physical examination (Screening, Days 1 and 21), neurological examination (Days 1 and 21), and ECG (Screening, Days 1, 7, 14, 20, 21 and Followup).
5 weeks
Positive and Negative Symptom Scale (PANSS) total score.
Screening, Day 1, 3, 7, 14 and 21
Adverse events (Daily), weight (Screening, Days 1, and 21) and girth (Days 1 and 21), vital signs (Screening, Days 1, 3, 7, 14, 21 and Followup),
5 weeks
Extrapyramidal Symptom Rating Scale (Screening, Days 1, 3, 7, 14 and 21) and the Stanford Sleepiness Scale (Days 1, 3, 7, 14 and 21).
4 weeks

Secondary Endpoints

PANSS-derived Marder factor scores (positive, negative, disorganized thought, hostility/excitement, anxiety/depression)
Screening, Day 1, 3, 7, 14 and 21
PANSS positive, negative, and general psychopathology subscales
Screening, Day 1, 3, 7, 14 and 21
Clinical Global Impression Scale-S (severity), and Clinical Global Impression Scale-I (improvement)
Screening and Days 1, 3, 7, 14 and 21
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
A2EXPERIMENTAL -
A5PLACEBO_COMPARATOR -
A4ACTIVE_COMPARATOR -
A3EXPERIMENTAL -
A1EXPERIMENTAL -

Interventions

NameTypeDescription
PF-00217830DRUGPF-00217830 5 mg, oral capsule, once daily for 21 days
PlaceboOTHERPlacebo, oral capsule, once daily for 21 days
AripiprazoleDRUGAripiprazole 15 mg, oral capsule, once daily for 21 days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: Key inclusion criteria include: * Have a current diagnosis of schizophrenia. * Increase in symptoms over the past 2-4 weeks. * Willing to remain inpatients for the duration of the trial. Exclusion Criteria: * Subjects with a current DSM-IV axis I diagnosis other than schizoph...

Countries:United StatesIndiaRussiaUkraine
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Frequently asked questions about PF-00217830

What is PF-00217830 used for?

PF-00217830 was studied for the treatment of schizophrenia, specifically for acute exacerbation of the condition. It is an investigational small molecule that was developed by Pfizer as a potential antipsychotic therapy. The compound was evaluated in a Phase 2 clinical trial but has not been approved for any indication.

What does PF-00217830 target?

PF-00217830 targets the dopamine D2 receptor, also known as DRD2. It acts as a partial agonist at this receptor. This mechanism is intended to modulate dopamine signaling, which is implicated in schizophrenia. The target class is a partial agonist, distinguishing it from full antagonists or agonists.

Who is developing PF-00217830?

PF-00217830 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. Pfizer is the sponsor of the clinical program for this compound. The drug remains an investigational asset in Pfizer's pipeline.

What phase is PF-00217830 in?

PF-00217830 is in Phase 2 clinical development. It has completed one Phase 2 trial but has not advanced to Phase 3. The drug is investigational and has not received FDA approval for any indication.

What clinical trials is PF-00217830 in?

PF-00217830 has been studied in one completed Phase 2 clinical trial, NCT00580125. This trial was a dose-response study evaluating the safety, efficacy, and pharmacokinetics of PF-00217830 compared with placebo in patients with acute exacerbation of schizophrenia. It enrolled 164 participants across the United States, India, Russia, and Ukraine.