NCT04145128 is a Phase 1 clinical trial of AG881 in Healthy Volunteers, sponsored by Agios Pharmaceuticals, Inc..

Who is sponsoring NCT04145128?

NCT04145128 is sponsored by Agios Pharmaceuticals, Inc..

What drugs are being tested in NCT04145128?

Interventions in NCT04145128: AG881.

What condition does NCT04145128 study?

NCT04145128 studies Healthy Volunteers.

Is NCT04145128 still recruiting?

NCT04145128 is currently completed. Last updated 2 April 2020.

Last reviewed 2020-04-02 · How we verify

NCT04145128

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate AG-881 in Healthy Japanese and Non-Asian Participants

Completed Phase 1 Last updated 2 April 2020

What this trial tests

Phase 1 trial testing AG881 in Healthy Volunteers in 32 participants. Completed in 18 December 2019.

Timeline

2 October 2019

Primary endpoint
11 December 2019

18 December 2019

Quick facts

Lead sponsor	Agios Pharmaceuticals, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	2 October 2019
Primary completion	11 December 2019
Estimated completion	18 December 2019
Sites	1 location across United States

Drugs / interventions tested

AG881 — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Agios Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to compare the pharmacokinetics (PK) and safety of AG-881 in healthy Japanese and Non-Asian participants after single oral doses of 10 mg and 50 mg of AG-881.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A Phase 1, Open-Label, Single Ascending (Two Levels) Dose Study to Evaluate the Pharmacokinetics of Vorasidenib in Healthy Japanese and Non-Asian Participants.
Limsakun T, Man A, Nguyen D, Hossain M. · · 2026 · PMID 42053456 · DOI 10.1002/jcph.70196

Verify or expand the search:

Other trials of AG881

Trials testing the same drug.

NCT03343197 — Study of AG-120 and AG-881 in Subjects With Low Grade Glioma · Phase 1 · completed
NCT02492737 — Study of Orally Administered AG-881 in Patients With Advanced Hematologic Malignancies With an IDH1 and/or IDH2 Mutation · Phase 1 · completed

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

NCT07504003 — Influence of Training Session Duration on Improvements in Physiological Resilience to Exercise · NA · recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
NCT07495813 — A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease · Phase 1 · recruiting
NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting

Other Agios Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT07075640 — A Study to Determine the Safety and Tolerability of AG-236 and How it is Absorbed, Broken Down, and Eliminated From the · Phase 1 · recruiting
NCT06745271 — A Study to Determine How Tebapivat is Absorbed, Broken Down, and Removed From the Body and the Extent to Which Tebapivat · Phase 1 · completed
NCT06648824 — Study of How Mitapivat Affects Midazolam Blood Levels in Healthy Participants · Phase 1 · completed
NCT06286033 — Single and Multiple Ascending Dose Study and Food Effect Study for AG181 · Phase 1 · completed
NCT05610657 — A Pharmacokinetic Study of Mitapivat in Participants With Moderate Hepatic Impairment Compared to Matched Healthy Contro · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04145128 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Agios Pharmaceuticals, Inc.
Last refreshed: 2 April 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04145128.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing