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Anti-metabolites

Part 1: Single Ascending Dose (SAD) 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose and multiple time points postdose from day 1 to day 17
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I weigh at least 50 kilograms.
Select...
I am a woman who hasn't had a period for 12 months and my blood test shows I am in menopause.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose and multiple time points postdose from day 1 to day 17
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose and multiple time points postdose from day 1 to day 17 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Food Effect: Apparent Oral Clearance (CL/F) of AG-181
Food Effect: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181
Food Effect: Area Under the Concentration-time Curves (AUCs) of AG-181
+6 more
Secondary outcome measures
Food Effect: Number of Participants with AEs and SAEs by Type, Severity, and Relationship to Study Drug
MAD: Accumulation Ratio for Area Under the Concentration-time Curve (RA_AUC) of AG-181
MAD: Accumulation Ratio for Cmax (RA_Cmax) of AG-181
+20 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 3: Food EffectExperimental Treatment1 Intervention
Participants will receive a single dose of AG-181 orally, once on Day 1 of the fasted phase, followed by an additional single dose administered on Day 1 of the phenylalanine (Phe)-restricted diet phase and Day 1 of the high-fat meal phase.
Group II: 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 III: 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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Agios Pharmaceuticals, Inc.Lead Sponsor
52 Previous Clinical Trials
4,086 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which specific criteria determine the eligibility of individuals for participation in this clinical trial?

"To be considered for participation, individuals must be in good health and aged between 18 and 55 years. This study aims to enroll approximately 120 patients."

Answered by AI

Has Part 3 of the study on food impact been given clearance by the FDA?

"The safety assessment for Part 3: Food Effect in this study has been rated as 1 on a scale of 1 to 3 by our team at Power. This Phase 1 trial indicates that there is minimal available data supporting both the safety and efficacy of the intervention."

Answered by AI

How large is the participant pool for this clinical investigation?

"Affirmative. The details on clinicaltrials.gov reveal that this investigation is currently seeking eligible participants. Initially shared on February 20th, 2024, the latest revision was made on February 23rd of the same year. A total of 120 individuals are sought to participate from a single designated site."

Answered by AI

Are eligible patients able to enroll in this ongoing trial at the present time?

"Affirmative. The details on clinicaltrials.gov specify that this investigation is currently seeking candidates. This trial was first listed on February 20, 2024, and most recently revised on February 23, 2024. Enrollment of about 120 participants will take place at one designated site."

Answered by AI

Is there an age limit for potential participants over 45 years old in this study?

"Applicants eligible for this research study must be aged between 18 and 55 years old. Notably, there are a total of 67 studies tailored to those under 18 and an additional 375 aimed at participants over the age of 65."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Safety Study of Single and Multiple Doses of AG-181 in Healthy Participants
2024. "A Safety Study of Single and Multiple Doses of AG-181 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06286033.
~80 spots leftby Jun 2025
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