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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-03

Study Completion Date

2017-11-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase I Study of AG-348 in Healthy Volunteers

NCT02108106

Healthy Volunteer

COMPLETED PHASE1

A Phase I Study of AG-348 in Healthy Volunteers

NCT02149966

Healthy Volunteer

COMPLETED PHASE1

A Study to Evaluate the Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability of AG-348 in Healthy Male Participants Following Administration of a Single Oral Dose of [14C]AG-348 and Concomitant Single Intravenous Microdose of [13C6]AG-348

NCT03703505

Healthy Volunteers

COMPLETED PHASE1

Study to Evaluate the Pharmacokinetics, Safety, and QTc Effect of AG-348 in Healthy Subjects of Japanese Origin and Non-Asian Origin

NCT03250598

Healthy Japanese Non-Asian

COMPLETED PHASE1

Single and Multiple Ascending Dose Study and Food Effect Study for AG181

NCT06286033

Healthy Volunteers

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sequence A

Group Type ACTIVE_COMPARATOR

AG-348 Sequence A

Intervention Type 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 B

Group Type ACTIVE_COMPARATOR

AG-348 Sequence B

Intervention Type 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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AG-348 Sequence A

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)

Intervention Type DRUG

AG-348 Sequence B

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)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes