NCT04540965

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

Double-Blind, Randomized, 2-Way Crossover Evaluation of the Impact of a Histamine-H2 Receptor Antagonist (H2RA) on the Pharmacokinetics of Telaglenastat Administered to Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Calithera Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Telaglenastat	Glutaminase inhibitor
DRUG	Famotidine	Histamine-H2 Receptor Antagonist
DRUG	Placebo for famotidine	Placebo for Histamine-H2 Receptor Antagonist

Timeline

• Start date: 2020-09-22
• Primary completion: 2020-12-08
• Completion: 2020-12-08
• First posted: 2020-09-07
• Last updated: 2021-03-09

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study