Recent Updates
Recently added Catalysts

Methadone

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
ACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment13
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01099748Estimate The Effect Of Lersivirine On The Pharmacokinetics Of S- And R-MethadonePHASE1 COMPLETED 13 — — May 1, 2010Jun 1, 2010Aug 30, 20101 United States
Unlock Drug Trial Details
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
Unlock Study Endpoints
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)
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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
Unlock Eligibility Criteria