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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: AG-348 Sequence A; Drug: AG-348 Sequence B

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Covance Clinical Research Unit, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sequence A	Drug: AG-348 Sequence A; Treatment Period 1 Single 50 mg dose of AG-348 administered as a capsule formulation (2 × 25 mg capsules); Washout Period 7 days; Treatment Period 2 Single 50 mg dose of AG-348 administered as a tablet formulation (1 × 50 mg tablet)
Active Comparator: Sequence B	Drug: AG-348 Sequence B; Treatment Period 1 Single 50 mg dose of AG-348 administered as a tablet formulation (1 × 50 mg tablet); Washout Period 7 days; Treatment Period 2 Single 50 mg dose of AG-348 administered as a capsule formulation (2 × 25 mg capsules)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	AG-348 Maximum Plasma Concentration	Pharmacokinetic sampling for AG-348 will be taken for 72 hours (3 days) after single dose
AUC0-last and AUC0-∞	AG-348 Area Under the Curve	Pharmacokinetic sampling for AG-348 will be taken for 72 hours (3 days) after single dose

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Agios Pharmaceuticals, Inc.
• Investigators: Study Chair: Medical Affairs, Agios Pharmaceuticals, Inc, Agios Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2017
• Primary Completion (Actual): November 13, 2017
• Study Completion (Actual): November 13, 2017

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: January 10, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 10, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Healthy Volunteers
• Other Study ID Numbers: AG348-C-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No