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Impact of a Histamine H2 Receptor Antagonist (H2RA) on the Pharmacokinetics (PK) of Telaglenastat in Healthy Subjects

NCT04540965 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-03-09

No results posted yet for this study

Summary

This study is designed to formally evaluate the impact of famotidine, an H2R antagonist, on the pharmacokinetics of telaglenastat.

This study will be conducted in up to 22 healthy volunteers, who meet all of the inclusion criteria and none of the exclusion criteria. The study is double-blinded, randomized 2-way crossover in design.

Subjects will receive four 200 mg tablets of telaglenastat either in the presence or absence of 20 mg famotidine (H2R-antagonist) with a 4-day wash-out period in between each regimen.

Conditions

  • Drug Interaction

Interventions

DRUG

Telaglenastat

Glutaminase inhibitor

DRUG

Famotidine

Histamine-H2 Receptor Antagonist

DRUG

Placebo for famotidine

Placebo for Histamine-H2 Receptor Antagonist

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Calithera Biosciences, Inc

    lead INDUSTRY

Principal Investigators

  • Paul Griffin, Dr. · Nucleus Network

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2020-09-22
Primary Completion
2020-12-08
Completion
2020-12-08
FDA Drug
Yes

Countries

  • Australia

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 NCT04540965 on ClinicalTrials.gov