Study to Evaluate the Relative Bioavailability and Safety... | NCT03397329

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

NCT03397329

Sponsor

Agios Pharmaceuticals, Inc.

Status

Completed

Last Update Posted

Jan 12, 2018Actual

Enrollment

26Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

AG-348 Sequence A
AG-348 Sequence B

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 3, 2017Actual

Primary Completion Date

Nov 13, 2017Actual

Completion Date

Nov 13, 2017Actual

First Submitted Date

Oct 25, 2017

First Submission Date that Met QC Criteria

Jan 10, 2018

First Posted Date

Jan 12, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2018

Last Update Posted Date

Jan 12, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sequence A	Active Comparator		Drug: AG-348 Sequence A
Sequence B	Active Comparator		Drug: AG-348 Sequence B

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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)

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided