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A Drug-Drug Interaction Study to Assess the CYP1A2 and CYP3A4 Interaction Potential of TEV-56286 (anle138b)

NCT05532358 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-03-23

No results posted yet for this study

Summary

The purpose of this healthy volunteers drug-drug interaction study is to assess the CYP1A2 and CYP3A4 perpetrator interaction potential and CYP1A2 victim potential of TEV-56286 (anle138b).

Conditions

  • Healthy Volunteers

Interventions

DRUG

anle138b (TEV-56286)

Anle138b (TEV-56286) as perpetrator

DRUG

Fluvoxamine 100 mg QD for 5 days

Anle138b (TEV-56286) as victim

Sponsors & Collaborators

  • Aptuit

    collaborator INDUSTRY

  • Quotient Sciences

    collaborator INDUSTRY

  • Teva Pharmaceutical Industries, Ltd.

    collaborator INDUSTRY

  • MODAG GmbH

    lead INDUSTRY

Principal Investigators

  • Nand Singh, MD · Quotient Sciences Mere Way Ruddington Fields Ruddington Nottingham NG11 6JS, UK

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-12
Primary Completion
2023-01-28
Completion
2023-02-10

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05532358 on ClinicalTrials.gov