Healthy VolunteersPhase 1NCT06286033
Single and Multiple Ascending Dose Study and Food Effect Study for AG181
A Phase 1 study testing AG-181 in people with Healthy Volunteers, run by Agios Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The primary purpose of this study is to assess the safety and tolerability of AG-181 in healthy participants after oral administration of single ascending dose (SAD) of AG-181 in Part 1 and multiple ascending dose (MAD) in Part 2 along with the effect of food on the pharmacokinetics (PK) of single oral doses of AG-181… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AG-181
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2024to 9 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing to participate in the study, give written informed consent, and comply with the study restrictions.
- Body mass index in the range of 18.0 to 30.0 kilograms per square meter (kg/m^2).
- Weight ≥ 50 kilograms (kg) at screening.
- Healthy status as defined by the absence of evidence of any clinically significant, in the opinion of the Investigator, active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology, and urinalysis.
- Ability and willingness to refrain from alcohol-, caffeine-, and methylxanthine-containing beverages or food (e.g., coffee, tea, cola, chocolate, energy drinks) from 72 hours (3 days) before administration of the first dose of study drug through follow-up.
- All values for hematology and clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations, as judged by the Investigator.
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- For women of child bearing potential (WOCBP)*, have a negative serum pregnancy test at Screening and during admission to the clinic.
- *WOCBP are defined as sexually mature women who have not undergone a hysterectomy, bilateral oophorectomy, or tubal occlusion; or who have not been naturally postmenopausal. WOCBP must use an acceptable method of contraception from Screening and until 14 days or 5 half-lives of AG-181, whichever is longer, after last dose of AG-181. WOCBP using hormonal contraception as a highly effective form of contraception must also use an acceptable barrier method.
- Male participants with female partners of childbearing potential must use a condom during treatment and for 14 days or 5 half-lives of AG-181, whichever is longer, after last dose of AG-181.
- Male participants must agree not to donate sperm during the study and for 14 days or 5 half-lives of AG-181, whichever is longer, after the last dose of study drug.
- 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.
- Participants must have discontinued use of prescription drugs (including topical skin preparations other than nonsteroidal/nonantibiotic nonprescription moisturizers) within 2 weeks or 5 half-lives (whichever is longer) of the first dose of study drug, and over-the-counter (OTC) medication (excluding routine vitamins) within 7 days of the first dose of study drug, unless agreed as not clinically relevant by the Investigator and Medical Monitor (or designee).
Who cannot join
- Women who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 14 days or 5 half-lives of AG-181, whichever is longer, after last dose of study drug.
- Males with female partners who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 14 days or 5 half-lives of AG-181, whichever is longer, after last dose of study drug.
- Prior exposure to AG-181.
- Use of any investigational drug or device within 30 days before administration of the first dose of study drug.
- Any disease which, in the opinion of the Investigator, poses an unacceptable risk to the participants.
- Clinically significant history of, including treatment within an Emergency Department for, any drug sensitivity, drug allergy, or food allergy, as determined by the Investigator (such as anaphylaxis, hepatotoxicity, or treatment with steroids or epinephrine).
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- Creatinine clearance <90 milliliters per minute (mL/min) (by Cockcroft-Gault formula) at screening.
- Aspartate aminotransferase >upper limit of normal (ULN) or alanine aminotransferase >ULN at screening.
- Use of tobacco or nicotine products in the 48 hours (2 days) prior to administration of the first dose of study drug.
- Strenuous activity, sunbathing, and contact sports within 48 hours (2 days) prior to administration of the first dose of study drug.
- History of donation of more than 450 milliliters (mL) of blood within 60 days prior to administration of the first dose of study drug.
- Plasma or platelet donation within 7 days prior to administration of the first dose of study drug.
- History within the 12 months before Screening of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink=12 ounce (oz) beer, 5 oz wine, and 1.5 oz spirits). Alcohol consumption will be prohibited 72 hours prior to administration of the first dose of study drug and until discharge.
- Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies at screening.
- Consumption of any nutrients known to modulate cytochrome P450 (CYP450) enzymes activity (e.g., grapefruit or grapefruit juice, pomelo juice, star fruit, or Seville [blood] orange products) within 14 days prior to administration of the first dose of study drug.
- Positive alcohol or drug screen (cannabinoids, amphetamines, methamphetamines, 3,4-methylenedioxy-N-methylamphetamine [ecstasy], opiates, methadone, oxycodone, phencyclidine, cocaine, cotinine, benzodiazepines, and barbiturates) at screening or admission to the clinical facility.
- 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.
- History of long-QT syndrome, torsade de pointes, or any risk factors for torsades de pointes in the opinion of the investigator.
- A history in any family member of any of the following: sudden cardiac death, unexplained death, long-QT syndrome, or death from a primary dysrhythmia potentially associated with QT prolongation.
Trial locations and contacts
1 site in 1 country.
United States1 site
ICON 1255 East 3900 South
Salt Lake City, Utah, 84124
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AG-181 in Healthy Participants
The primary purpose of this study is to assess the safety and tolerability of AG-181 in healthy participants after oral administration of single ascending dose (SAD) of AG-181 in Part 1 and multiple ascending dose (MAD) in Part 2 along with the effect of food on the pharmacokinetics (PK) of single oral doses of AG-181 in healthy participants in Part 3.
- Conditions
- Healthy Volunteers
- Being tested
- AG-181, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG-181Drug
AG-181 tablets
PlaceboDrug
AG-181 matched-placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) | Experimental | 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. Receives: Drug: AG-181; Drug: Placebo |
| Part 2: Multiple Ascending Dose (MAD) | Experimental | 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. Receives: Drug: AG-181; Drug: Placebo |
| Part 3: Food Effect - Sequence 1: AB | Experimental | 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 1 week. Receives: Drug: AG-181 |
| Part 3: Food Effect - Sequence 2: BA | Experimental | 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 1 week. Receives: Drug: AG-181 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAD: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) by Type, Severity, and Relationship to Study Drug
Measured: Up to Day 7
MAD: Number of Participants with AEs and SAEs by Type, Severity, and Relationship to Study Drug
Measured: Up to Day 26
Food Effect: Maximum Observed Plasma Concentration (Cmax) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Area Under the Concentration-time Curve up to the Last Quantifiable Concentration (AUC0-last) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Time to Reach Maximum Observed Concentration (tmax) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Terminal Elimination Rate Constant (Kel) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Terminal Elimination Half-Life (t1/2) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Apparent Oral Clearance (CL/F) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 4
Secondary outcomes (23)
SAD: Maximum Observed Plasma Concentration (Cmax) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 4
SAD: Time to Reach Maximum Observed Concentration (tmax) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 4
SAD: Terminal Elimination Rate Constant (Kel) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 4
SAD: Terminal Elimination Half-Life (t1/2) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 4
SAD: Area Under the Concentration-time Curves (AUCs) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 4
SAD: Apparent Oral Clearance (CL/F) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 4
SAD: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 4
SAD: Renal Clearance (CLR) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 3
SAD: Total Percent of AG-181 Dose Excreted Unchanged in Urine (Fet%)
Measured: Predose and multiple time points postdose from Day 1 to Day 3
SAD: Percent of AG-181 Dose Excreted Unchanged in Urine Between Time 1 and Time 2 (Fet1-t2%)
Measured: Predose and multiple time points postdose from Day 1 to Day 3
SAD: Cumulative Amount of AG-181 Drug Excreted in Urine (Ae0-t)
Measured: Predose and multiple time points postdose from Day 1 to Day 3
SAD: Amount of AG-181 Drug Excreted in Urine Between Time 1 and Time 2 (Aet1-t2)
Measured: Predose and multiple time points postdose from Day 1 to Day 3
MAD: Maximum Observed Plasma Concentration (Cmax) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Time to Reach Maximum Observed Concentration (tmax) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Terminal Elimination Rate Constant (Kel) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Terminal Elimination Half-Life (t1/2) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Area Under the Concentration-time Curve (AUC) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Apparent Oral Clearance (CL/F) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Time to Maximum Observed Plasma Concentration at Steady State (Cmax_ss) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Accumulation Ratio for Cmax (RA_Cmax) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 14
MAD: Accumulation Ratio for Area Under the Concentration-time Curve (RA_AUC) of AG-181
Measured: Predose and multiple time points postdose from Day 1 to Day 14
Food Effect: Number of Participants with AEs and SAEs by Type, Severity, and Relationship to Study Drug
Measured: Up to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start20 Feb 2024
- Primary completion9 Oct 2025
- Study completion9 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Agios Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- There are 3 parts in this study. Part 1 and 2 follows a sequential design. Part 3 is a food effect study with a 2x2 crossover design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agios Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286033
- Sponsor's protocol ID
- AG181-C-001
- Status last verified
- Dec 2025
- First submitted
- 23 Feb 2024
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AG-181 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06286033
- Acronym / sponsor ID
- AG181-C-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Agios Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 9 Oct 2025 (actual)
- Study completion
- 9 Oct 2025 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to assess the safety and tolerability of AG-181 in healthy participants after oral administration of single ascending dose (SAD) of AG-181 in Part 1 and multiple ascending dose (MAD) in Part 2 along with the effect of food on the pharmacokinetics (PK) of single oral doses of AG-181 in healthy participants in Part 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- There are 3 parts in this study. Part 1 and 2 follows a sequential design. Part 3 is a food effect study with a 2x2 crossover design.
| Arm | Type | Receives |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) | Experimental | Drug: AG-181, Drug: PlaceboParticipants will receive a range of doses of AG-181 or placebo, orally, once on Day 1. AG-181 will be given under fasted conditions. |
| Part 2: Multiple Ascending Dose (MAD) | Experimental | Drug: AG-181, Drug: PlaceboParticipants 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. |
| Part 3: Food Effect - Sequence 1: AB | Experimental | Drug: AG-181Participants 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 1 week. |
| Part 3: Food Effect - Sequence 2: BA | Experimental | Drug: AG-181Participants 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 1 week. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Willing to participate in the study, give written informed consent, and comply with the study restrictions.
- Body mass index in the range of 18.0 to 30.0 kilograms per square meter (kg/m^2).
- Weight ≥ 50 kilograms (kg) at screening.
- Healthy status as defined by the absence of evidence of any clinically significant, in the opinion of the Investigator, active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology, and urinalysis.
- Ability and willingness to refrain from alcohol-, caffeine-, and methylxanthine-containing beverages or food (e.g., coffee, tea, cola, chocolate, energy drinks) from 72 hours (3 days) before administration of the first dose of study drug through follow-up.
Key exclusion criteria (19 listed)
- Women who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 14 days or 5 half-lives of AG-181, whichever is longer, after last dose of study drug.
- Males with female partners who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 14 days or 5 half-lives of AG-181, whichever is longer, after last dose of study drug.
- Prior exposure to AG-181.
- Use of any investigational drug or device within 30 days before administration of the first dose of study drug.
- Any disease which, in the opinion of the Investigator, poses an unacceptable risk to the participants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AG-181AG-181 tablets | Drug | Part 1: Single Ascending Dose (SAD), Part 2: Multiple Ascending Dose (MAD), Part 3: Food Effect - Sequence 1: AB, Part 3: Food Effect - Sequence 2: BA |
| PlaceboAG-181 matched-placebo tablets | Drug | Part 1: Single Ascending Dose (SAD), Part 2: Multiple Ascending Dose (MAD) |
Primary outcome
SAD: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) by Type, Severity, and Relationship to Study Drug
Time frame: Up to Day 7
MAD: Number of Participants with AEs and SAEs by Type, Severity, and Relationship to Study Drug
Time frame: Up to Day 26
Food Effect: Maximum Observed Plasma Concentration (Cmax) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Area Under the Concentration-time Curve up to the Last Quantifiable Concentration (AUC0-last) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Time to Reach Maximum Observed Concentration (tmax) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Terminal Elimination Rate Constant (Kel) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Terminal Elimination Half-Life (t1/2) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Apparent Oral Clearance (CL/F) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
23 secondary outcomes
SAD: Maximum Observed Plasma Concentration (Cmax) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
SAD: Time to Reach Maximum Observed Concentration (tmax) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
SAD: Terminal Elimination Rate Constant (Kel) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
SAD: Terminal Elimination Half-Life (t1/2) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
SAD: Area Under the Concentration-time Curves (AUCs) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
SAD: Apparent Oral Clearance (CL/F) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
SAD: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
SAD: Renal Clearance (CLR) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 3
SAD: Total Percent of AG-181 Dose Excreted Unchanged in Urine (Fet%)
Time frame: Predose and multiple time points postdose from Day 1 to Day 3
SAD: Percent of AG-181 Dose Excreted Unchanged in Urine Between Time 1 and Time 2 (Fet1-t2%)
Time frame: Predose and multiple time points postdose from Day 1 to Day 3
SAD: Cumulative Amount of AG-181 Drug Excreted in Urine (Ae0-t)
Time frame: Predose and multiple time points postdose from Day 1 to Day 3
SAD: Amount of AG-181 Drug Excreted in Urine Between Time 1 and Time 2 (Aet1-t2)
Time frame: Predose and multiple time points postdose from Day 1 to Day 3
MAD: Maximum Observed Plasma Concentration (Cmax) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Time to Reach Maximum Observed Concentration (tmax) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Terminal Elimination Rate Constant (Kel) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Terminal Elimination Half-Life (t1/2) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Area Under the Concentration-time Curve (AUC) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Apparent Oral Clearance (CL/F) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Time to Maximum Observed Plasma Concentration at Steady State (Cmax_ss) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Accumulation Ratio for Cmax (RA_Cmax) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 14
MAD: Accumulation Ratio for Area Under the Concentration-time Curve (RA_AUC) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 14
Food Effect: Number of Participants with AEs and SAEs by Type, Severity, and Relationship to Study Drug
Time frame: Up to Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AG-181 in people with Healthy Volunteers, run by Agios Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAD: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) by Type, Severity, and Relationship to Study Drug (time frame: Up to Day 7). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.