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Anti-metabolites

AG-181 for Healthy Subjects

Phase 1

Recruiting

Research Sponsored by Agios Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Weight ≥ 50 kilograms (kg) at screening

Postmenopausal women are women who have not menstruated at all for at least the 12 months before providing informed consent and who have an elevated follicle-stimulating hormone (FSH) level indicative of menopause during screening

Must not have

Prolonged heart rate-corrected QT interval (QTc) [heart rate-corrected QT interval by Fridericia's formula (QTcF) >450 milliseconds (msec)] during screening and prior to first dose of study drug

Creatinine clearance <90 milliliters per minute (mL/min) (by Cockcroft-Gault formula) at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

"The main goal of this study is to see if AG-181 is safe and well-tolerated when given to healthy participants in increasing doses in Part 1 and multiple doses in Part 2.

Who is the study for?

This trial is for healthy individuals who want to participate in a study testing the safety of a new medication, AG-181. The study will involve taking single or multiple doses of the drug with and without food to see how it's absorbed and tolerated.

What is being tested?

AG-181 is being tested in this trial. Participants will take either AG-181 or a placebo (a pill without any active drug) to compare effects. The study has three parts: one for single doses, another for multiple doses, and a third part to see how food affects the drug's absorption.

What are the potential side effects?

Since AG-181 is new, potential side effects are not fully known but may include typical reactions seen with oral medications such as stomach upset, headache, dizziness, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I weigh at least 50 kilograms.

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I am a woman who hasn't had a period for 12 months and my blood test shows I am in menopause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My heart's electrical activity (QTc interval) is longer than 450 milliseconds.

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My kidney function, measured by creatinine clearance, is below 90 mL/min.

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I have previously been treated with AG-181.

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I have not donated more than 450 mL of blood in the last 60 days.

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My family has a history of sudden or unexplained deaths and heart rhythm problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part 3: Food Effect - Sequence 2: BAExperimental Treatment1 Intervention

Participants will receive a single oral dose of AG-181 on Day 1 of Period 1 under fed (high fat meal) condition (B) followed by single oral dose of AG-181 on Day 1 of Period 2 under fasted condition (A). Each period will be separated by a washout period of 72 hours.

Group II: Part 3: Food Effect - Sequence 1: ABExperimental Treatment1 Intervention

Participants will receive single oral dose of AG-181 on Day 1 of Period 1 under fasted condition (A) followed by single oral dose of AG-181 on Day 1 of Period 2 under fed (high fat meal) condition (B). Each period will be separated by a washout period of 72 hours.

Group III: Part 2: Multiple Ascending Dose (MAD)Experimental Treatment2 Interventions

Participants will receive a range of doses of AG-181 or placebo twice daily (BID) for 13 days and a single dose on Day 14 under fasted conditions.

Group IV: Part 1: Single Ascending Dose (SAD)Experimental Treatment2 Interventions

Participants will receive a range of doses of AG-181 or placebo, orally, once on Day 1. AG-181 will be given under fasted conditions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670