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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03397329
• Other study ID #: AG348-C-005
• Status: Completed
• Phase: Phase 1
• First received: October 25, 2017
• Last updated: January 10, 2018
• Start date: October 3, 2017
• Est. completion date: November 13, 2017

Study information

• Verified date: January 2018
• Source: Agios Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 13, 2017
• Est. primary completion date: November 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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)
• 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)

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit, Inc.	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Agios Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	AG-348 Maximum Plasma Concentration	Pharmacokinetic sampling for AG-348 will be taken for 72 hours (3 days) after single dose
Primary	AUC0-last and AUC0-8	AG-348 Area Under the Curve	Pharmacokinetic sampling for AG-348 will be taken for 72 hours (3 days) after single dose
Secondary	Assessment of adverse events		From first dose of study drug to 10 (± 1) days after single-dose of AG-348]