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

NCT03397329 | Completed Phase 1 FDA Drug

• 1 other identifier: AG348-C-005
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Assessment of adverse events

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

Study Arms (2)

Sequence A

ACTIVE COMPARATOR

Drug: AG-348 Sequence A

Sequence B

ACTIVE COMPARATOR

Drug: AG-348 Sequence B

Interventions

AG-348 Sequence A DRUG

1. Treatment Period 1 Single 50 mg dose of AG-348 administered as a capsule formulation (2 × 25 mg capsules) 2. Washout Period 7 days 3. Treatment Period 2 Single 50 mg dose of AG-348 administered as a tablet formulation (1 × 50 mg tablet)

Sequence A

AG-348 Sequence B DRUG

1. Treatment Period 1 Single 50 mg dose of AG-348 administered as a tablet formulation (1 × 50 mg tablet) 2. Washout Period 7 days 3. Treatment Period 2 Single 50 mg dose of AG-348 administered as a capsule formulation (2 × 25 mg capsules)

Sequence B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Agios Pharmaceuticals, Inc.: lead

Study Sites (1)

Covance Clinical Research Unit, Inc.

Dallas, Texas, 75247, United States

Location

Study Officials

• Medical Affairs, Agios Pharmaceuticals, Inc

  Agios Pharmaceuticals, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: January 12, 2018
• Study Start: October 3, 2017
• Primary Completion: November 13, 2017
• Study Completion: November 13, 2017
• Last Updated: January 12, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)