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Completed

NCT Number: NCT03397329

Study to Evaluate the Relative Bioavailability and Safety of the AG-348 Tablet and Capsule Formulations 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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit, Inc.

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AG-348 Sequence A

Drug
  • 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)

AG-348 Sequence B

Drug
  • 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)

Primary outcomes

  1. Cmax

    Time frame: Pharmacokinetic sampling for AG-348 will be taken for 72 hours (3 days) after single dose

    AG-348 Maximum Plasma Concentration

  2. AUC0-last and AUC0-∞

    Time frame: Pharmacokinetic sampling for AG-348 will be taken for 72 hours (3 days) after single dose

    AG-348 Area Under the Curve

Secondary outcomes

  1. Assessment of adverse events

    Time frame: From first dose of study drug to 10 (± 1) days after single-dose of AG-348]

Sponsors and collaborators

Lead sponsor

Agios Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 12, 2018
Registry last updated
Jan 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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