Healthy VolunteersPhase 1NCT04128787
A Study to Compare the Relative Bioavailability of Two AG-881 Formulations and Evaluate the Effect of Food and Omeprazole on the Pharmacokinetics of AG-881
A Phase 1 study testing AG881 Formulation 1, AG881 Formulation 2 and Omeprazole 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 single-dose pharmacokinetics (PK) of two formulations (Formulation 1 and Formulation 2) of AG-881 and to examine the effect of food and multiple-dose omeprazole on the single-dose PK of AG-881 Formulation 2 in healthy adult participants. 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 Formulation 1, AG881 Formulation 2 and Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 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
- Healthy, adult, male or female (WONCBP) participants, 18-55 years of age, inclusive, at Screening.
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECG, as deemed by the Investigator or designee. 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 non-childbearing 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.
- A non-vasectomized, male participants 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 non-vasectomized male).
- If a 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.
Who cannot join
- Participant is 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 (e.g., 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 (e.g., 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 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 first check-in.
- Positive results at Screening for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.
- QT interval Fridericia's formula (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.
- Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at Screening.
- Seated 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, ibuprofen (1.2 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 (e.g., proton-pump inhibitors [with the exception of omeprazole administered as part of the study schedule], H2-receptor antagonists, antacids) for 28 days, or drugs that can prolong the QT interval for 21 days, prior to the first dosing and throughout the study. Appropriate sources (e.g., 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.
- Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study.
- Any allergy or intolerance to food substances which will be provided on the study.
- Is lactose intolerant.
- 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 Study to Compare the Relative Bioavailability of Two AG-881 Formulations and to Evaluate the Effect of Food and Multiple-Dose Omeprazole on the Pharmacokinetics of a Single Dose of AG-881 in Healthy Adult Subjects
The purpose of this study is to compare the single-dose pharmacokinetics (PK) of two formulations (Formulation 1 and Formulation 2) of AG-881 and to examine the effect of food and multiple-dose omeprazole on the single-dose PK of AG-881 Formulation 2 in healthy adult participants. This study will also assess the safety and tolerability of single-dose AG-881 (Formulation 1 and 2) alone and of AG-881 Formulation 2 when administered with and without food and when coadministered with omeprazole in healthy adult subjects.
- Conditions
- Healthy Volunteers
- Being tested
- AG881 Formulation 1, AG881 Formulation 2, Omeprazole
- Keywords
- Bioavailability Study, Pharmacokinetic study, AG-881
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG881 Formulation 1Drug
AG881 uncoated tablets
AG881 Formulation 2Drug
AG881 film-coated tablets
OmeprazoleDrug
Omeprazole capsules
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence ABCD | Experimental | Participants will receive Treatment A (AG-881 Formulation 1, 50 mg, tablet orally, under fasted condition once on Day 1 of Period 1) followed by Treatment B (AG-881 Formulation 2, 50 mg, tablet orally, under fasted condition once on Day 1 of Period 2) followed by Treatment C (AG-881 Formulation 2, 50 mg, tablet, orally, under fed condition once on Day 1 of Period 3) followed by Treatment D (omeprazole 40 mg capsule, orally, once daily on Days 1 to 4 and AG-881 Formulation 2, 50 mg, tablet, orally, under fasted condition, once on Day 4 of Period 4). Each period will be separated by a Washout Period of 21 days. Receives: Drug: AG881 Formulation 1; Drug: AG881 Formulation 2; Drug: Omeprazole |
| Treatment Sequence BCAD | Experimental | Participants will receive Treatment B in Period 1 followed by Treatment C in Period 2 then Treatment A in Period 3 followed by Treatment D in Period 4. Each period will be separated by a Washout Period of 21 days. Receives: Drug: AG881 Formulation 1; Drug: AG881 Formulation 2; Drug: Omeprazole |
| Treatment Sequence CABD | Experimental | Participants will receive Treatment C in Period 1 followed by Treatment A in Period 2 then Treatment B in Period 3 followed by Treatment D in Period 4. Each period will be separated by a Washout Period of 21 days. Receives: Drug: AG881 Formulation 1; Drug: AG881 Formulation 2; Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-Time Curve From Time 0 to the Last Observed Non-Zero Concentration (AUC0-t) of AG-881 Formulation 1 without Food
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Concentration-Time Curve From Time 0 to the Last Observed Non-Zero Concentration (AUC0-t) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of AG-881 Formulation 1 without Food
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Maximum Observed Concentration (Cmax) of AG-881 Formulation 1 without Food
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Maximum Observed Concentration (Cmax) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Concentration-Time Curve, From Time 0 to 504 Hours Postdose (AUC0-504) of AG-881 Formulation 1 without Food
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Concentration-Time Curve, From Time 0 to 504 Hours Postdose (AUC0-504) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of AG-881 Formulation 1 without Food
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Terminal Elimination Half-life (t½) of AG-881 Formulation 1 without Food
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Terminal Elimination Half-life (t½) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Time Delay Between Drug Administration and the Onset of Absorption (tlag) of AG-881 Formulation 1 without Food
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Time Delay Between Drug Administration and the Onset of Absorption (tlag) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Time to Reach Maximum Observed Concentration (Tmax) of AG-881 Formulation 1 without Food
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Time to Reach Maximum Observed Concentration (Tmax) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Volume of Distribution After Oral (Extravascular) Administration (Vd/F) of AG-881 Formulation 1 without Food
Measured: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Volume of Distribution After Oral (Extravascular) Administration (Vd/F) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
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 Abnormalities in Triplicate 12-lead Electrocardiograms (ECGs)
Measured: Up to 21 days in Period 1, 2, 3 (Each period is 21 days); up to 25 days in Period 4 (Period 4 is 25 days)
Number of Participants with Abnormalities in Vital Sign Measurements
Vital sign measurements will include body temperature, respiratory rate, blood pressure, and heart rate.
Measured: Up to 21 days in Period 1, 2, 3 (Each period is 21 days); up to 25 days in Period 4 (Period 4 is 25 days)
Columbia-suicide Severity Rating Scale (C-SSRS) Score
The C-SSRS is a questionnaire scale to detect emergent suicide symptoms (suicidal ideation or actual suicidal behavior) during the course of this study. Questions are either answered yes/no or are on a scale of 1 (low severity) to 5 (high severity).
Measured: Up to 21 days in Period 1, 2, 3 (Each period is 21 days); up to 25 days in Period 4 (Period 4 is 25 days)
Number of Participants with Abnormalities in Clinical Laboratory Tests
Clinical laboratory assessments will include hematology, serum chemistry, coagulation, and urinalysis.
Measured: Up to 21 days in Period 1, 2, 3 (Each period is 21 days); up to 25 days in Period 4 (Period 4 is 25 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 Study Drug (Up to 91 days)'
Number of Participants with Abnormalities in Physical Examinations
Physical examination will include, examination of skin, neurological, respiratory, cardiovascular, and gastrointestinal systems.
Measured: Up to 21 days in Period 1, 2, 3 (Each period is 21 days); up to 25 days in Period 4 (Period 4 is 25 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start30 Sep 2019
- Primary completion18 Dec 2019
- Study completion18 Dec 2019
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT04128787
- Sponsor's protocol ID
- AG881-C-007
- Status last verified
- Jul 2021
- First submitted
- 4 Oct 2019
- Last updated
- 21 Jul 2021
- 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 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Compare the Relative Bioavailability of Two AG-881 Formulations and to Evaluate the Effect of Food and Multiple-Dose Omeprazole on the Pharmacokinetics of a Single Dose of AG-881 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04128787
- Acronym / sponsor ID
- AG881-C-007
- Conditions
- Healthy Volunteers
- Keywords
- Bioavailability Study, Pharmacokinetic study, AG-881
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Agios Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 16 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 single-dose pharmacokinetics (PK) of two formulations (Formulation 1 and Formulation 2) of AG-881 and to examine the effect of food and multiple-dose omeprazole on the single-dose PK of AG-881 Formulation 2 in healthy adult participants. This study will also assess the safety and tolerability of single-dose AG-881 (Formulation 1 and 2) alone and of AG-881 Formulation 2 when administered with and without food and when coadministered with omeprazole in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence ABCD | Experimental | Drug: AG881 Formulation 1, Drug: AG881 Formulation 2, Drug: OmeprazoleParticipants will receive Treatment A (AG-881 Formulation 1, 50 mg, tablet orally, under fasted condition once on Day 1 of Period 1) followed by Treatment B (AG-881 Formulation 2, 50 mg, tablet orally, under fasted condition once on Day 1 of Period 2) followed by Treatment C (AG-881 Formulation 2, 50 mg, tablet, orally, under fed condition once on Day 1 of Period 3) followed by Treatment D (omeprazole 40 mg capsule, orally, once daily on Days 1 to 4 and AG-881 Formulation 2, 50 mg, tablet, orally, under fasted condition, once on Day 4 of Period 4). Each period will be separated by a Washout Period of 21 days. |
| Treatment Sequence BCAD | Experimental | Drug: AG881 Formulation 1, Drug: AG881 Formulation 2, Drug: OmeprazoleParticipants will receive Treatment B in Period 1 followed by Treatment C in Period 2 then Treatment A in Period 3 followed by Treatment D in Period 4. Each period will be separated by a Washout Period of 21 days. |
| Treatment Sequence CABD | Experimental | Drug: AG881 Formulation 1, Drug: AG881 Formulation 2, Drug: OmeprazoleParticipants will receive Treatment C in Period 1 followed by Treatment A in Period 2 then Treatment B in Period 3 followed by Treatment D in Period 4. Each period will be separated by a Washout Period of 21 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy, adult, male or female (WONCBP) participants, 18-55 years of age, inclusive, at Screening.
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECG, as deemed by the Investigator or designee. 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 non-childbearing 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.
Key exclusion criteria (26 listed)
- Participant is 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 (e.g., 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 (e.g., 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 |
|---|---|---|
| AG881 Formulation 1AG881 uncoated tablets | Drug | Treatment Sequence ABCD, Treatment Sequence BCAD, Treatment Sequence CABD |
| AG881 Formulation 2AG881 film-coated tablets | Drug | Treatment Sequence ABCD, Treatment Sequence BCAD, Treatment Sequence CABD |
| OmeprazoleOmeprazole capsules | Drug | Treatment Sequence ABCD, Treatment Sequence BCAD, Treatment Sequence CABD |
Primary outcome
Area Under the Concentration-Time Curve From Time 0 to the Last Observed Non-Zero Concentration (AUC0-t) of AG-881 Formulation 1 without Food
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Concentration-Time Curve From Time 0 to the Last Observed Non-Zero Concentration (AUC0-t) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of AG-881 Formulation 1 without Food
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Maximum Observed Concentration (Cmax) of AG-881 Formulation 1 without Food
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Maximum Observed Concentration (Cmax) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Concentration-Time Curve, From Time 0 to 504 Hours Postdose (AUC0-504) of AG-881 Formulation 1 without Food
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Concentration-Time Curve, From Time 0 to 504 Hours Postdose (AUC0-504) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of AG-881 Formulation 1 without Food
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
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 (t½) of AG-881 Formulation 1 without Food
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 (t½) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Time Delay Between Drug Administration and the Onset of Absorption (tlag) of AG-881 Formulation 1 without Food
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Time Delay Between Drug Administration and the Onset of Absorption (tlag) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Time to Reach Maximum Observed Concentration (Tmax) of AG-881 Formulation 1 without Food
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Time to Reach Maximum Observed Concentration (Tmax) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Volume of Distribution After Oral (Extravascular) Administration (Vd/F) of AG-881 Formulation 1 without Food
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Volume of Distribution After Oral (Extravascular) Administration (Vd/F) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
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 Abnormalities in Triplicate 12-lead Electrocardiograms (ECGs)
Time frame: Up to 21 days in Period 1, 2, 3 (Each period is 21 days); up to 25 days in Period 4 (Period 4 is 25 days)
Number of Participants with Abnormalities in Vital Sign Measurements
Time frame: Up to 21 days in Period 1, 2, 3 (Each period is 21 days); up to 25 days in Period 4 (Period 4 is 25 days)
Columbia-suicide Severity Rating Scale (C-SSRS) Score
Time frame: Up to 21 days in Period 1, 2, 3 (Each period is 21 days); up to 25 days in Period 4 (Period 4 is 25 days)
Number of Participants with Abnormalities in Clinical Laboratory Tests
Time frame: Up to 21 days in Period 1, 2, 3 (Each period is 21 days); up to 25 days in Period 4 (Period 4 is 25 days)
Number of Participants with Adverse Events (AEs)
Time frame: Up to 28 Days After Last Dose of Study Drug (Up to 91 days)'
Number of Participants with Abnormalities in Physical Examinations
Time frame: Up to 21 days in Period 1, 2, 3 (Each period is 21 days); up to 25 days in Period 4 (Period 4 is 25 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 21 Jul 2021.
- 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.
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 Formulation 1, AG881 Formulation 2 and Omeprazole 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 8 inclusion and 26 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 21 Jul 2021. 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 Concentration-Time Curve From Time 0 to the Last Observed Non-Zero Concentration (AUC0-t) of AG-881 Formulation 1 without Food (time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881). The study lists 18 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 21 Jul 2021.