A Phase 1, Single-Dose, Open-Label Trial to Evaluate the Pharmacokinetics and Safety of AG-120 in Healthy Male Japanese Subjects Relative to Healthy Male Caucasian Subjects

Agios Pharmaceuticals, Inc.1 site in 1 country60 target enrollmentMarch 31, 2017

ConditionsHealthy

Interventionsivosidenib (AG-120)

Drugsivosidenib (AG-120)

Overview

Phase: Phase 1
Intervention: ivosidenib (AG-120)
Conditions: Healthy
Sponsor: Agios Pharmaceuticals, Inc.
Enrollment: 60
Locations: 1
Primary Endpoint: AUC
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this Phase I, single-dose, open-label trial is to evaluate the pharmacokinetics and safety of ivosidenib (AG-120) in healthy, adult male Japanese and Caucasian subjects. The study plans to evaluate 3 cohorts of a single oral dose of ivosidenib (AG-120) in Japanese and Caucasian subjects. Pharmacokinetic sampling will take place serially through-out the duration of subject participation.

Registry

clinicaltrials.gov

Start Date

March 31, 2017

End Date

September 6, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Agios Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Applicable to Japanese Subjects Only: Japanese subjects must have been born in Japan, have both parents and grandparents of Japanese origin, and not have lived outside of Japan for more than 5 years.
•Applicable to Caucasian Subjects Only: Non-Japanese subjects must be Caucasian (ie, White) but may be of any ethnicity.
•Healthy male subjects between 18 and 55 years of age (inclusive).
•Provision of voluntary, written informed consent.
•Capable of adhering to trial restrictions and examination schedules, in the opinion of the Investigator.
•Must be able to communicate with the Investigator.
•Must be in good health as determined by the Investigator according to past medical history, physical examination, vital signs, clinical laboratory test results, and ECGs.
•Must have a body mass index (BMI) between 18 and 29 kg/m2 (inclusive), and body weight between 50-120kg.
•Clinical laboratory test results (serum chemistry, hematology, and urinalysis) must be within normal limits or considered by the Investigator to be not clinically significant after confirmation with the Agios Medical Monitor.
•Vital signs (systolic and diastolic blood pressure, pulse rate, and oral body temperature) will be assessed in the supine position after the subject has rested for at least 5 minutes. Subject must be afebrile with vital signs within the following ranges at screening, Day -1 and pre dose: Systolic blood pressure: 90 to 140 mmHg; Diastolic blood pressure: 50 to 90 mmHg; Pulse rate: 40 to 110 bpm

Exclusion Criteria

•Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from providing informed consent or participating in the trial in the opinion of the Investigator.
•Any condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he were to participate in the trial.
•Recent history (within 3 years prior to dosing) of any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorder.
•Use of any prescribed systemic or topical medication within 30 days or 5 terminal half-lives, whichever is longer, of IMP administration.
•Exposure to an investigational drug within 30 days prior to IMP administration or 5 half lives of that investigational drug, if known (whichever is longer).
•Use of any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines, eg, St. John's Wort) within 7 days of IMP administration.
•Any surgical or medical condition that could affect drug absorption, distribution, metabolism, or excretion (eg, gastrectomy and cholecystectomy)
•Subjects who plan to have any elective or medical procedures during the conduct of the trial (eg, dental procedure).
•History of clinically significant multiple drug allergies (ie, 2 or more).
•Any clinically significant allergic disease.