Japanese Bridging Study of Ivosidenib (AG-120) in Healthy Subjects

ClinicalTrials.gov ID: NCT03071770

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT03071770
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Agios Pharmaceuticals, Inc.; Industry
Enrollment: 60 participants

Conditions and interventions

Conditions

Healthy

Interventions

ivosidenib (AG-120) Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 55 Years
Sex: Male
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 31, 2017 (Actual)
Primary completion: May 9, 2017 (Actual)
Completion: Sep 6, 2017 (Actual)
Last update posted: Jan 11, 2018

2017

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
West Coast Clinical Trial (WCCT)	Cypress	California	90630	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03071770, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 11, 2018 · Synced Nov 14, 2026