Study to Evaluate the Relative Bioavailability and Safety of the AG-348 Tablet and Capsule Formulations in Healthy Adults
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 1/14/2018 |
Start Date: | October 3, 2017 |
End Date: | November 13, 2017 |
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
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.
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.
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.
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