Healthy Volunteers
Conditions
Keywords
Healthy Volunteers
Brief summary
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 single-dose administration in healthy adult subjects. Pharmacokinetic sampling will take place serially at specified times during conduct of the study.
Interventions
DRUGAG-348 Sequence A
1. Treatment Period 1 Single 50 mg dose of AG-348 administered as a capsule formulation (2 × 25 mg capsules) 2. Washout Period 7 days 3. Treatment Period 2 Single 50 mg dose of AG-348 administered as a tablet formulation (1 × 50 mg tablet)
DRUGAG-348 Sequence B
1. Treatment Period 1 Single 50 mg dose of AG-348 administered as a tablet formulation (1 × 50 mg tablet) 2. Washout Period 7 days 3. Treatment Period 2 Single 50 mg dose of AG-348 administered as a capsule formulation (2 × 25 mg capsules)
Sponsors
Agios Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Be a male or female aged 18 to 55 years, inclusive. * Have a body mass index (BMI) of ≥ 18.5 to ≤ 29.0 kg/m2 at Screening. * Agrees to abstain from any alcohol consumption. * Be healthy overall with no clinically significant medical abnormalities, as determined by the Investigator through evaluation of the subject's medical history and Screening vital signs, ECG, physical examination, and laboratory assessments.
Exclusion criteria
* Have undergone any major surgical procedure within the 3 months prior to Screening. * Has at Screening or has had within the 12 months prior to Screening any significant illness. * Test positive at Screening for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), or human immunodeficiency virus (HIV). * Have a Screening systolic blood pressure (BP) reading of ≥140 mmHg (≥150 mmHg in subjects \>45 years of age) OR a diastolic BP reading of ≥90 mmHg. * Has any history of drug or alcohol abuse within the 2 years prior to Screening. * Is a current smoker or user of any other tobacco product. * Have had, including by voluntary donation, \> 400 mL of blood collected within the 3 months prior to Screening. * Have taken within the 14 days prior to study drug dosing any prescription medication, over-the counter medication, or nonprescription preparation-including vitamins, minerals, phytotherapeutic/herbal/plant-derived preparations, or grapefruit juice-unless deemed acceptable by the Investigator OR have taken within the 28 days prior to study drug dosing any restricted product known to strongly induce CYP3A4 metabolism (eg, St. John's Wort). * Have participated in another clinical research study within the 3 months prior to Screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Pharmacokinetic sampling for AG-348 will be taken for 72 hours (3 days) after single dose | AG-348 Maximum Plasma Concentration |
| AUC0-last and AUC0-∞ | Pharmacokinetic sampling for AG-348 will be taken for 72 hours (3 days) after single dose | AG-348 Area Under the Curve |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of adverse events | From first dose of study drug to 10 (± 1) days after single-dose of AG-348] |
Countries
United States
Outcome results
None listed