Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2026-01-06 @ 9:59 AM
Study NCT ID:
NCT02944435
Status:
COMPLETED
Last Update Posted:
2017-01-04
First Post:
2016-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative, Pharmacokinetic Study of CB-839 Capsule and Tablet Formulations in Healthy Adults
Sponsor:
Calithera Biosciences, Inc
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: