Recent Updates
Recently added Catalysts

anle138b

Phase 1

Healthy Volunteers | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Mar 23, 2023

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05532358A Drug-Drug Interaction Study to Assess the CYP1A2 and CYP3A4 Interaction Potential of TEV-56286 (anle138b)PHASE1 COMPLETED 54 — — Sep 12, 2022Feb 10, 2023Mar 23, 20231 United Kingdom
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Oral pharmacokinetics (PK) of caffeine administered without TEV-56286 in healthy volunteers in the fasted state (Part I).
Day 1

PK parameter: Cmax for caffeine.

Oral pharmacokinetics (PK) of midazolam administered without TEV-56286 in healthy volunteers in the fasted state (Part I).
Day 1

PK parameter: Cmax for midazolam.

Oral pharmacokinetics (PK) of caffeine after single co-administration with TEV-56286 in healthy volunteers in the fasted state (Part I).
Day 3

Cmax for caffeine.

Oral pharmacokinetics (PK) of midazolam after single co-administration with TEV-56286 in healthy volunteers in the fasted state (Part I).
Day 3

Cmax for midazolam

Oral pharmacokinetics (PK) of caffeine after repeated administration of TEV-56286 in healthy volunteers in the fasted state (Part I).
Day 18

PK parameter: Cmax for caffeine.

Oral pharmacokinetics (PK) of midazolam after repeated administration of TEV-56286 in healthy volunteers in the fasted state (Part I).
Day 18

PK parameter: Cmax for midazolam.

Oral pharmacokinetics (PK) of TEV-56286 without fluvoxamine in healthy volunteers after repeated administration in the fasted state (Part II).
Day 14

PK parameter: Cmax for TEV-56286.

Oral pharmacokinetics (PK) of TEV-56286 in healthy volunteers after repeated co-administration with fluvoxamine in the fasted state.
Day 19

PK parameter: Cmax for TEV-56286 (Part II).

Secondary Endpoints
Oral pharmacokinetics (PK) of substrates caffeine and midazolam
Day 1, Day 3, Day 18
Oral pharmacokinetics (PK) of TEV-56286 after repeated co-administration with fluvoxamine
Day 19
Oral pharmacokinetics (PK) of TEV-56286 as perpetrator drug after co-administration with caffeine and midazolam
Day 3
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
anle138b (TEV-56286) as perpetrator (part I)EXPERIMENTALDrug: TEV-56286 300 mg QD (single dose and multiple dose for 14 days) Victim drugs: Caffeine 200 mg Midazolam 2 mg
anle138b (TEV-56286) as victim (part II)EXPERIMENTALDrug: fluvoxamine 100 mg QD for 5 days Victim drug: TEV-56286 150 mg QD for 14 days + 5 days of co-administation with fluvoxamine
Interventions
NameTypeDescription
anle138b (TEV-56286)DRUGAnle138b (TEV-56286) as perpetrator
Fluvoxamine 100 mg QD for 5 daysDRUGAnle138b (TEV-56286) as victim
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males or healthy females of non-childbearing potential * Must provide written informed consent for participation in the study and must be able to understand the study requirements * Body mass index (BMI) 18.5 to 32.0 kg/m2. * Must agree to adhere to the contraception r...

Countries:United Kingdom
Unlock Eligibility Criteria