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Methadone

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Aug 30, 2010

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment13

FDA Designations

No designations recorded

Clinical trial landscape

Methadone · 1 trial · 1 indication

Phase 1 1
NCT01099748Estimate The Effect Of Lersivirine On The Pharmacokinetics Of S- And R-MethadoneHealthy Volunteers
COMPLETED13 Analytics
PHASE1COMPLETED
Estimate The Effect Of Lersivirine On The Pharmacokinetics Of S- And R-Methadone
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Study Endpoints

Primary Endpoints

R-methadone and S-methadone plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h on Days 1 and 11
Day 12

Secondary Endpoints

Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments
Day 12
Symptoms of methadone withdrawal as assessed by the Short Opiate Withdrawal Scale (SOWS), Desires for Drug Questionnaire (DDQ) and Pupillary Diameter measurement performed on Days 0 -12.
Day 12
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MethadoneACTIVE_COMPARATORDose of methadone must not change from 1 week prior to study start and through the duration of the study.
Lersivirine + MethadoneEXPERIMENTAL -

Interventions

NameTypeDescription
MethadoneDRUGMethadone 50 - 150 mg QD (Day 1)
Lersivirine + MethadoneDRUGLersivirine 1000 mg QD + Methadone 50 - 150 mg QD (Days 2-11)
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history except drug abuse), full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory test...

Countries:United States
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Frequently asked questions about Methadone

What is Methadone used for in Healthy Volunteers?

Methadone is a small molecule being studied in healthy volunteers to assess its pharmacokinetics. In the completed Phase 1 trial, researchers estimated the effect of lersivirine on the pharmacokinetics of S- and R-methadone. The study enrolled 13 participants in the United States and was active-controlled, though it was not randomized or double-blinded.

Who makes Methadone?

Methadone is being developed by Pfizer, Inc., which trades under the ticker PFE. The company is conducting clinical research on this small molecule in the therapeutic area of Other, with a focus on healthy volunteers. Pfizer's development program includes a completed Phase 1 trial involving 13 participants.

What phase is Methadone in?

Methadone is in Phase 1 clinical development. The investigational drug is being studied in healthy volunteers, and the single trial in its development program has been completed. This Phase 1 study was active-controlled and enrolled 13 participants in the United States. Methadone remains in early-stage clinical research.

What clinical trials is Methadone in?

Methadone has one completed clinical trial, NCT01099748, titled "Estimate The Effect Of Lersivirine On The Pharmacokinetics Of S- And R-Methadone." This Phase 1 study enrolled 13 healthy volunteers in the United States, with participants aged 18 years and older. The trial was active-controlled, not randomized or double-blinded, and included both sexes.

Is Methadone FDA approved?

Methadone is an investigational drug in clinical development and has not been approved by the FDA. It is currently in Phase 1 trials, with one completed study in healthy volunteers. The development program is being conducted by Pfizer, Inc. Approval status is not indicated beyond its investigational stage.