Healthy VolunteersPhase 1NCT04145128
A Study to Evaluate AG-881 in Healthy Japanese and Non-Asian Participants
A Phase 1 study testing AG881 in people with Healthy Volunteers, run by Agios Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the pharmacokinetics (PK) and safety of AG-881 in healthy Japanese and Non-Asian participants after single oral doses of 10 mg and 50 mg of AG-881. 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?
- AG881
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2019to 18 Dec 2019
- 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
- Have provided voluntary written informed consent.
- Adult male or female, 18 to 55 years of age, inclusive, at Screening.
- Continuous nonsmoker who has not used nicotine containing products for at least 3 months prior to the first dosing and throughout the study.
- Have a body mass index (BMI) of ≥ 18.0 and ≤ 32.0 kg/m^2 at Screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECG. Liver function tests (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP], and bilirubin [total and direct]) must be ≤ the upper limit of normal (ULN).
- Female participants must be of nonchildbearing potential defined as a female who has undergone one of the following sterilization procedures at least 6 months prior to the first dosing: hysteroscopic sterilization; bilateral tubal ligation or bilateral salpingectomy; hysterectomy; bilateral oophorectomy. Or is postmenopausal with amenorrhea for at least 1 year prior to the first dosing and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status.
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- A nonvasectomized, male participant must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days after the last dosing. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to the first dosing of study drug. A male who has been vasectomized less than 4 months prior to study first dosing must follow the same restrictions as a nonvasectomized male).
- Male participants must agree not to donate sperm from the first dosing until 90 days after the last dosing.
- Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
- Additional Criteria for Japanese participants only: be first-generation Japanese, defined as meeting all of the following conditions: born in Japan; has 2 Japanese biological parents and 4 Japanese biological grandparents; has lived outside of Japan for <5 years; has made no significant changes in lifestyle, including diet, since leaving Japan.
- Additional Criteria for Non-Asian participants only: Non-Asian participants will have 2 biological parents and 4 biological grandparents of Non-Asian descent.
Who cannot join
- Mentally or legally incapacitated or has significant emotional problems at the time of the Screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the Investigator or designee.
- History of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or pose an additional risk to the participant (eg, history or presence of rashes) by their participation in the study.
- History of stomach or intestinal surgery that would potentially alter absorption/secretion; or any major surgical procedure within the previous 3 months prior to Screening.
- History of severe and/or uncontrolled ventricular arrhythmias, or other factors that increase the risk of QT prolongation or arrhythmic events (eg, heart failure, hypokalemia, family history of long QT interval syndrome).
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
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- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
- Any positive responses on the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Female participants of childbearing potential.
- Female participants with a positive pregnancy test or who are lactating.
- Positive urine drug or alcohol results at Screening or Day -1/Day 21.
- Positive results at Screening for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) antibodies.
- QTcF interval is >450 msec, or QRS interval >110 msec, or PR interval >220 msec, or participants who have ECG findings deemed abnormal with clinical significance by the Investigator or designee at Screening.
- Supine blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at Screening.
- Supine heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at Screening.
- Estimated creatinine clearance <90 mL/min at Screening.
- Unable to refrain from or anticipates the use of: any drug, including prescription and non-prescription medications, herbal remedies, and vitamin supplements, beginning 14 days prior to the first dosing and throughout the study. After first dosing, acetaminophen (<2 g per 24 hour) may be administered at the discretion of Investigator or designee. Hormone replacement therapy will not be allowed; any drugs known to be strong inducers of CYP3A, CYP2C9, or CYP2C19 enzymes including St. John's Wort and/or, gastric acid reducing agents (eg, protonpump inhibitors, H2-receptor antagonists, antacids) for 28 days, or drugs that can prolong the QT interval for 28 days, prior to the first dosing and throughout the study. Appropriate sources (eg, Flockhart TableTM) will be consulted to confirm lack of PK/Pharmacodynamic (PD) interaction with study drug.
- Refuses to abstain from alcohol from 48 hours prior to the first dosing and throughout the study.
- Refuses to abstain from grapefruit-containing foods or beverages or Seville orange containing foods or beverages from 14 days prior to the first dosing and throughout the study.
- Donation of blood or significant blood loss within 56 days prior to the first dose.
- Plasma donation within 7 days prior to the first dose.
- Receipt of blood or blood products within 2 months prior to the first dose.
- Participation in another clinical study within 30 days prior to the first dose. The 30-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Single Ascending Dose Study to Evaluate AG-881 in Healthy Japanese and Non-Asian Subjects
The purpose of this study is to compare the pharmacokinetics (PK) and safety of AG-881 in healthy Japanese and Non-Asian participants after single oral doses of 10 mg and 50 mg of AG-881.
- Conditions
- Healthy Volunteers
- Being tested
- AG881
- Keywords
- Pharmacokinetic study, AG-881
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG881Drug
Also called Vorasidenib, AGI 23088, AGI 0023088
AG-881 tablets.
| Study group | Role | What they receive |
|---|---|---|
| AG-881 | Experimental | Participants will receive AG-881 10 mg, tablet orally, once in Period 1 followed by AG-881 50 mg, tablet orally, once in Period 2. Period 1 and Period 2 will be separated by a washout period of 20 days between doses. Receives: Drug: AG881 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Time of the Last Measurable Concentration (AUC0-last) of AG881
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-∞) of AG881
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Clearance Following Extravascular Dosing (CL/F) of AG881
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Maximum Plasma Concentration Observed (Cmax) of AG881
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Terminal Elimination Half-life (t1/2) of AG881
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Time of Maximum Plasma Concentration (tmax) of AG881
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Volume of Distribution (Vd/F) of AG881
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Secondary outcomes (6)
Number of Participants with Changes in Clinical Laboratory Tests from Screening to 22 days in Period 1 and 2
Clinical laboratory assessments will include hematology, blood chemistry, and urinalysis.
Measured: Screening (Day -1) up to 22 days in Period 1 and 2 (Each Period is 22 days)
Number of Participants with Changes in Physical Examinations from Screening to 22 days in Period 1 and 2
Physical examination will include, examination of skin, neurological, respiratory, cardiovascular, and gastrointestinal systems.
Measured: Screening (Day -1) up to 22 days in Period 1 and 2 (Each Period is 22 days)
Number of Participants with Changes in Vital Sign Measurements from Screening to 22 days in Period 1 and 2
Vital sign measurements will include body temperature, respiratory rate, blood pressure, and heart rate.
Measured: Screening (Day -1) up to 22 days in Period 1 and 2 (Each Period is 22 days)
Number of Participants with Changes in Electrocardiograms (ECGs) from Screening to 22 days in Period 1 and 2
Measured: Screening (Day -1) up to 22 days in Period 1 and 2 (Each Period is 22 days)
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence associated with the use of a drug, whether or not considered drug-related.
Measured: Up to 28 days after last dose of AG-881 (Up to 71 days)
Number of Participants Using Concomitant Medications
Measured: Up to 28 days after last dose of AG-881 (Up to 71 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start2 Oct 2019
- Primary completion11 Dec 2019
- Study completion18 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agios Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Affairs, Study chair, Agios Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145128
- Sponsor's protocol ID
- AG881-C-008
- Status last verified
- Apr 2020
- First submitted
- 29 Oct 2019
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Limsakun T, Man A, Nguyen D, Hossain M. A Phase 1, Open-Label, Single Ascending (Two Levels) Dose Study to Evaluate the Pharmacokinetics of Vorasidenib in Healthy Japanese and Non-Asian Participants. J Clin Pharmacol. 2026 May;66(5):e70196. doi: 10.1002/jcph.70196.
PubMed 42053456
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single Ascending Dose Study to Evaluate AG-881 in Healthy Japanese and Non-Asian Subjects
- ClinicalTrials.gov ID
- NCT04145128
- Acronym / sponsor ID
- AG881-C-008
- Conditions
- Healthy Volunteers
- Keywords
- Pharmacokinetic study, AG-881
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Agios Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 30 Oct 2019 (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 purpose of this study is to compare the pharmacokinetics (PK) and safety of AG-881 in healthy Japanese and Non-Asian participants after single oral doses of 10 mg and 50 mg of AG-881.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AG-881 | Experimental | Drug: AG881Participants will receive AG-881 10 mg, tablet orally, once in Period 1 followed by AG-881 50 mg, tablet orally, once in Period 2. Period 1 and Period 2 will be separated by a washout period of 20 days between doses. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Have provided voluntary written informed consent.
- Adult male or female, 18 to 55 years of age, inclusive, at Screening.
- Continuous nonsmoker who has not used nicotine containing products for at least 3 months prior to the first dosing and throughout the study.
- Have a body mass index (BMI) of ≥ 18.0 and ≤ 32.0 kg/m^2 at Screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECG. Liver function tests (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP], and bilirubin [total and direct]) must be ≤ the upper limit of normal (ULN).
Key exclusion criteria (23 listed)
- Mentally or legally incapacitated or has significant emotional problems at the time of the Screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the Investigator or designee.
- History of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or pose an additional risk to the participant (eg, history or presence of rashes) by their participation in the study.
- History of stomach or intestinal surgery that would potentially alter absorption/secretion; or any major surgical procedure within the previous 3 months prior to Screening.
- History of severe and/or uncontrolled ventricular arrhythmias, or other factors that increase the risk of QT prolongation or arrhythmic events (eg, heart failure, hypokalemia, family history of long QT interval syndrome).
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 |
|---|---|---|
| AG881Also: Vorasidenib, AGI 23088, AGI 0023088AG-881 tablets. | Drug | AG-881 |
Primary outcome
Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Time of the Last Measurable Concentration (AUC0-last) of AG881
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-∞) of AG881
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Clearance Following Extravascular Dosing (CL/F) of AG881
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Maximum Plasma Concentration Observed (Cmax) of AG881
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Terminal Elimination Half-life (t1/2) of AG881
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Time of Maximum Plasma Concentration (tmax) of AG881
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Volume of Distribution (Vd/F) of AG881
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
6 secondary outcomes
Number of Participants with Changes in Clinical Laboratory Tests from Screening to 22 days in Period 1 and 2
Time frame: Screening (Day -1) up to 22 days in Period 1 and 2 (Each Period is 22 days)
Number of Participants with Changes in Physical Examinations from Screening to 22 days in Period 1 and 2
Time frame: Screening (Day -1) up to 22 days in Period 1 and 2 (Each Period is 22 days)
Number of Participants with Changes in Vital Sign Measurements from Screening to 22 days in Period 1 and 2
Time frame: Screening (Day -1) up to 22 days in Period 1 and 2 (Each Period is 22 days)
Number of Participants with Changes in Electrocardiograms (ECGs) from Screening to 22 days in Period 1 and 2
Time frame: Screening (Day -1) up to 22 days in Period 1 and 2 (Each Period is 22 days)
Number of Participants with Adverse Events (AEs)
Time frame: Up to 28 days after last dose of AG-881 (Up to 71 days)
Number of Participants Using Concomitant Medications
Time frame: Up to 28 days after last dose of AG-881 (Up to 71 days)
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 2 Apr 2020.
- Derived from this study: PubMed 42053456Limsakun T, Man A, Nguyen D, Hossain M. A Phase 1, Open-Label, Single Ascending (Two Levels) Dose Study to Evaluate the Pharmacokinetics of Vorasidenib in Healthy Japanese and Non-Asian Participants. J Clin Pharmacol. 2026 May;66(5):e70196. doi: 10.1002/jcph.70196.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Medical Affairs study chair
Agios Pharmaceuticals, Inc.
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 AG881 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 11 inclusion and 23 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 2 Apr 2020. 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?
Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Time of the Last Measurable Concentration (AUC0-last) of AG881 (time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04145128, which also lists 1 linked publication.
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 2 Apr 2020.