Status:
COMPLETED
Study to Evaluate the Relative Bioavailability and Safety of the AG-348 Tablet and Capsule Formulations in Healthy Adults
Lead Sponsor:
Agios Pharmaceuticals, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 capsul...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2017
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03397329
Start Date
October 3 2017
End Date
November 13 2017
Last Update
January 12 2018
Active Locations (1)
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1
Covance Clinical Research Unit, Inc.
Dallas, Texas, United States, 75247