Clinical trial NCT03397329: Study to Evaluate the Relative Bioavailability and Safety of the AG-348 Tablet and Capsule Formulations in Healthy Adults
Official title: A Phase 1, Randomized, Open-Label, Two-Period Crossover Study Evaluating the Relative Bioavailability and Safety of the AG-348 Tablet and Capsule Formulations After Single-Dose Administration in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Lead sponsor: Agios Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-12
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cmax
timeFrame: Pharmacokinetic sampling for AG-348 will be taken for 72 hours (3 days) after single dose
measure: AUC0-last and AUC0-∞
timeFrame: Pharmacokinetic sampling for AG-348 will be taken for 72 hours (3 days) after single dose
Secondary outcomes:
measure: Assessment of adverse events
timeFrame: From first dose of study drug to 10 (± 1) days after single-dose of AG-348]
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance Clinical Research Unit, Inc.
state: Texas
Study officials:
affiliation: Agios Pharmaceuticals, Inc.
name: Medical Affairs, Agios Pharmaceuticals, Inc
role: STUDY_CHAIR
References: