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anle138b

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

anle138b · 1 trial · 1 indication

Phase 1 1
NCT05532358A Drug-Drug Interaction Study to Assess the CYP1A2 and CYP3A4 Interaction Potential of TEV-56286 (anle138b)Healthy Volunteers
COMPLETED54 Analytics
PHASE1COMPLETED
A Drug-Drug Interaction Study to Assess the CYP1A2 and CYP3A4 Interaction Potential of TEV-56286 (anle138b)
Healthy VolunteersUnlock trial analytics

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
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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
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Eligibility Criteria

Age Range18 Years to 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
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Frequently asked questions about anle138b

What is anle138b?

anle138b is an investigational small molecule being developed by Teva Pharmaceutical Industries Limited (TEVA). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, and its therapeutic area is classified as Other.

What is anle138b used for?

anle138b is being studied for use in healthy volunteers. It is an investigational small molecule in Phase 1 clinical development. The drug is not approved for any indication and is still in clinical trials.

Who makes anle138b?

anle138b is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting clinical trials to evaluate the drug in healthy volunteers.

What phase is anle138b in?

anle138b is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers as part of early-stage clinical trials.

What clinical trials is anle138b in?

anle138b has one completed Phase 1 clinical trial, NCT05532358, titled "A Drug-Drug Interaction Study to Assess the CYP1A2 and CYP3A4 Interaction Potential of TEV-56286 (anle138b)". The trial enrolled 54 healthy volunteers in the United Kingdom.

Is anle138b the same as TEV-56286?

Yes, anle138b is also known as TEV-56286. The clinical trial NCT05532358 refers to the drug as TEV-56286 (anle138b), confirming that both names refer to the same investigational small molecule.