Study to Evaluate the Relative Bioavailability and Safety of the AG-348 Tablet and Capsule Formulations in Healthy Adults

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: AG-348 Sequence A; Drug: AG-348 Sequence B

• Registration Number: NCT03397329
• Lead Sponsor: Agios Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-03
• Study First Submitted: 2017-10-25
• Primary Completion: 2017-11-13
• Study Completion: 2017-11-13
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-10
• Last Update Submitted: 2018-01-10
• Study First Posted: 2018-01-12
• Last Update Posted: 2018-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A	AG-348 Sequence A	-
Sequence B	AG-348 Sequence B	-

Primary Outcome Measures

Name	Time	Method
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
Cmax	Pharmacokinetic sampling for AG-348 will be taken for 72 hours (3 days) after single dose	AG-348 Maximum Plasma Concentration

Secondary Outcome Measures

Name	Time	Method
Assessment of adverse events	From first dose of study drug to 10 (± 1) days after single-dose of AG-348]

Trial Locations

Locations (1)

Covance Clinical Research Unit, Inc.; 🇺🇸 Dallas, Texas, United States