Clinical trials: sponsored by Agios Pharmaceuticals, Inc.
Acute Myeloid Leukemia, Relapsed Adult AML
Ivosidenib Expanded Access Program in Relapsed/Refractory AML With an IDH1 Mutation
To provide access to ivosidenib monotherapy to patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation.
- Conditions
- Acute Myeloid Leukemia, Relapsed Adult AML, Relapsed Pediatric AML
- Trial name
- NCT03245424
- Testing
- ivosidenib (AG-120)
- Sponsor
- Agios Pharmaceuticals, Inc.
Hepatic Impairment
A Study of AG-120 (Ivosidenib) in Subjects With Mild or Moderate Hepatic Impairment or Normal Hepatic Function
Study AG120-C-012 is a Phase 1, open-label, single-dose study designed to evaluate the PK, safety, and tolerability of a single 500 mg AG-120 (Ivosidenib) dose in subjects with mild or moderate hepatic impairment (HI) compared to…
- Trial name
- NCT03282513
- Testing
- AG-120 (Ivosidenib)
- Where
- 2 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.
Healthy Volunteers
Study to Evaluate the Relative Bioavailability and Safety of the AG-348 Tablet and Capsule Formulations in Healthy Adults
The purpose of this Phase 1, randomized, open-label, two-period crossover study is to characterize and compare the pharmacokinetic (PK) profiles and evaluate the safety of the AG-348 tablet and capsule formulations after…
- Trial name
- NCT03397329
- Testing
- AG-348 Sequence A, AG-348 Sequence B
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.
Healthy
Japanese Bridging Study of Ivosidenib (AG-120) in Healthy Subjects
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.
- Trial name
- NCT03071770
- Testing
- ivosidenib (AG-120)
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.
Healthy, Japanese
Study to Evaluate the Pharmacokinetics, Safety, and QTc Effect of AG-348 in Healthy Subjects of Japanese Origin and Non-Asian Origin
The purpose of this Phase I, single-dose, open-label trial is to evaluate the pharmacokinetics, safety, and effect on QTc interval of AG-348 in healthy, adult Japanese and Non-Asian subjects.
- Conditions
- Healthy, Japanese, Non-Asian
- Trial name
- NCT03250598
- Testing
- AG-348
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.
Anemia
A Safety and Tolerability Study of AG-519 in Healthy Subjects
The purpose of the study is to investigate a drug called AG-519, which is being developed for the treatment of a disease called pyruvate kinase deficiency (also known as PK deficiency) and other forms of anemia.
- Trial name
- NCT02630927
- Testing
- AG-519
- Where
- United Kingdom
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.
Healthy
Drug-Drug Interaction Study of AG120 in Healthy Subjects
An Open-Label, 2-Period, Fixed Sequence Study to Determine the Effect of Multiple Oral Doses of Itraconazole on the Single Dose Pharmacokinetics of AG 120 in Healthy Adult Subjects.
- Trial name
- NCT02831972
- Testing
- AG120, Itraconazole
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.
Healthy
Food Effect Study of AG120 in Healthy Subjects
This will be a 2-part study. PART 1 is an open-label, randomized, food effect study of AG-120. Subjects will be enrolled to a fed/fasted or fasted/fed treatment sequence in a 2-period crossover design.
- Trial name
- NCT02579707
- Testing
- AG120
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.
Healthy Volunteers
Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-AG-120
The study is designed to characterize the absorption, metabolism, and excretion of AG-120 using radiolabeled drug in healthy adult male subjects to support its further development and registration.
- Trial name
- NCT02489513
- Testing
- [14C]-AG-120
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.
Healthy Volunteers
Food Effect Study of AG-221 in Healthy Male Subjects
AG-221 is a first-in-class drug targeted specifically to inhibit the IDH2 enzyme. Small molecule inhibition of the IDH enzyme represents a new, targeted approach to cancer treatment.
- Trial name
- NCT02218346
- Testing
- AG221
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.
Healthy Volunteer
A Phase I Study of AG-348 in Healthy Volunteers
This is a dose escalation study that will be conducted in healthy volunteers. Multiple cohorts of volunteers will receive ascending (increasingly higher) oral doses of AG-348 daily for 14 days to evaluate the safety and…
- Trial name
- AG-348MAD (NCT02149966)
- Testing
- AG-348
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.
Healthy Volunteer
A Phase I Study of AG-348 in Healthy Volunteers
This is a dose escalation study that will be conducted in healthy volunteers. Multiple cohorts of volunteers will receive ascending oral doses of AG-348 to evaluate the safety and tolerability of a single oral dose of AG-348, the…
- Trial name
- AG-348 SAD (NCT02108106)
- Testing
- AG-348
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.