Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-02-25 @ 8:16 PM
Study NCT ID:
NCT02387866
Status:
COMPLETED
Last Update Posted:
2018-10-30
First Post:
2015-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PK and Safety Study of AG-221 in Healthy Male Japanese Subjects and Healthy Male Caucasian Subjects
Sponsor:
Celgene
Organization:
Study Overview
Official Title:
A Phase 1, Single Ascending Dose, Open-label Study to Evaluate the Pharmacokinetics and Safety of AG-221 in Healthy Male Japanese Subjects Relative to Healthy Male Caucasian Subjects
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03723057
Has Expanded Access, NCT# Status:
NO_LONGER_AVAILABLE
Acronym:
None
Brief Summary:
This is a single ascending dose, open-label study that will evaluate the pharmacokinetics and safety of the AG-221 compound in normal, healthy volunteer male subjects (both Japanese and Caucasian).
Detailed Description:
This is a phase 1, single ascending dose study to evaluate the PK and safety of AG-221 in healthy adult male Japanese subjects relative to healthy adult male Caucasian subjects. A total of 60 subjects will be enrolled; 30 will be Japanese subjects and 30 will be Caucasian subjects. There will be a total of 3 cohorts. Cohort A will receive a single dose of 100 mg AG-221. Cohort B will receive a single dose of 50 mg AG-221. Cohort C will receive a single dose of 300 mg AG-221. Within each cohort, 10 subjects will be Japanese and 10 subjects will be Caucasian.
Investigational product (IP) will be administered orally with approximately 240 mL of noncarbonated, room-temperature water. Subjects will enter the clinic prior to the evening meal on the day before dosing (Day -1) and will take a single oral dose of AG-221 at Hour 0 on the dosing day (Day 1), following a 10 hour overnight fast. After the dose is administered, subjects will be observed for 7 days to assess the acute safety profile before the next higher, protocol specified dose cohorts can enroll. The Sponsor and Investigator will review all available safety information prior to escalation to the next cohort to ensure that no safety issues exist.
Subjects will be confined to the study center from Day -1 to Day 3. Subjects will be discharged from the study center upon completion of the 48 hour PK blood draw. Subjects will return to the study center for additional PK blood draws on Days 5, 8, 11, 15, 22 and 29. In the event that a subject discontinues from the study, an early termination visit will be performed.
Blood samples will be collected at the following time (hours) for analysis of AG-221 and AGI-16903 (minor, active metabolite in humans) concentrations: Pre-dose, 1, 2, 3, 4, 6, 9, 12, 18, 24, 48, 96, 168, 240, 336, 504 and 672 hours.
In accordance with the guidance for clinical pharmacokinetic studies in Japan, this study design was selected to obtain PK data from Japanese in comparison to Caucasian healthy subjects. As the IP is an anticancer agent and, following the Japanese guidance for global studies, a single dose design was chosen.
AG-221 is a novel, first-in-class compound targeted specifically to inhibit the mutated IDH2 enzyme. AG-221 is currently being studied in a Phase 1 dose escalation study in subjects with advanced hematologic malignancies harboring an IDH2 mutation (AG221-C-001). The AG221-C-001 study is currently being conducted in the United States and France. This Japanese PK bridging study is intended to provide single dose PK and safety information in healthy Japanese subjects, relative to healthy Caucasian
Investigational product (IP) will be administered orally with approximately 240 mL of noncarbonated, room-temperature water. Subjects will enter the clinic prior to the evening meal on the day before dosing (Day -1) and will take a single oral dose of AG-221 at Hour 0 on the dosing day (Day 1), following a 10 hour overnight fast. After the dose is administered, subjects will be observed for 7 days to assess the acute safety profile before the next higher, protocol specified dose cohorts can enroll. The Sponsor and Investigator will review all available safety information prior to escalation to the next cohort to ensure that no safety issues exist.
Subjects will be confined to the study center from Day -1 to Day 3. Subjects will be discharged from the study center upon completion of the 48 hour PK blood draw. Subjects will return to the study center for additional PK blood draws on Days 5, 8, 11, 15, 22 and 29. In the event that a subject discontinues from the study, an early termination visit will be performed.
Blood samples will be collected at the following time (hours) for analysis of AG-221 and AGI-16903 (minor, active metabolite in humans) concentrations: Pre-dose, 1, 2, 3, 4, 6, 9, 12, 18, 24, 48, 96, 168, 240, 336, 504 and 672 hours.
In accordance with the guidance for clinical pharmacokinetic studies in Japan, this study design was selected to obtain PK data from Japanese in comparison to Caucasian healthy subjects. As the IP is an anticancer agent and, following the Japanese guidance for global studies, a single dose design was chosen.
AG-221 is a novel, first-in-class compound targeted specifically to inhibit the mutated IDH2 enzyme. AG-221 is currently being studied in a Phase 1 dose escalation study in subjects with advanced hematologic malignancies harboring an IDH2 mutation (AG221-C-001). The AG221-C-001 study is currently being conducted in the United States and France. This Japanese PK bridging study is intended to provide single dose PK and safety information in healthy Japanese subjects, relative to healthy Caucasian
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?: