NCT02944435

A Comparative, Pharmacokinetic Study of CB-839 Capsule and Tablet Formulations in Healthy Adults

A Comparative, Randomized, Single-Dose, 2-Way Crossover Pharmacokinetic Comparability Study of CB-839 Administered as Capsule and Tablet Formulations in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Calithera Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, randomized, single-dose, 2-way crossover PK comparability study of CB-839 administered as capsule and tablet formulations in healthy adult subjects.

Detailed description

A new tablet formulation of CB-839 was recently developed in order to enable rapid, automated manufacturing of CB-839. Previous studies have used a capsule formulation of CB-839. This study will enable a PK comparison between CB-839 capsules and CB-839 tablets. This is a Phase 1, comparative, randomized, single-dose, 2-way crossover PK comparability study of CB-839 administered as capsule and tablet formulations in healthy adult subjects. Serial blood samples for PK analyses will be collected over a 24 hour period after each administration of CB-839. All subjects will be monitored for safety throughout their participation in the study.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	CB-839 Capsules	3 x 200 mg CB-839 Capsules (Reference Formulation)
DRUG	CB-839 Tablets	3 x 200 mg CB-839 Tablets (Test Formulation)

Timeline

• Start date: 2016-10-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2016-10-25
• Last updated: 2017-01-04

Locations

1 site across 1 country: United States