Healthy VolunteersPhase 1NCT02218346
Food Effect Study of AG-221 in Healthy Male Subjects
A Phase 1 study testing AG221 in people with Healthy Volunteers, run by Agios Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
AG-221 is a first-in-class drug targeted specifically to inhibit the IDH2 enzyme. Small molecule inhibition of the IDH enzyme represents a new, targeted approach to cancer treatment. Read more about this study
- Who is it for?
- Ages 18 to 56 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AG221
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Mar 2015
- 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 56 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male subjects 18 to 56 years of age, inclusive, at Screening.
- Subjects who are able to understand and sign informed consent prior to the conduct of any protocol-specific screening procedures.
- Subjects must be willing and able to complete all study assessments and procedures.
- Subjects, with the exception of those who have undergone vasectomy at least 6 months prior to Screening, must agree to use condom with spermicide as contraception (regardless of their female partner's childbearing potential or their partner's use of their own contraception) from Day 1 of Period 1 until 28 days following the last dose of study drug.
- Subjects must have a body weight ≥50 kg and body mass index (BMI) ≥18.5 and ≤32 kg/m2 at Screening.
- Subjects must be in general good health as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, and 12-lead ECGs at Screening or on Day -1 of each period.
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- Subjects must be non-smokers and have not used nicotine-containing products for at least 3 months prior to Screening.
- Subjects must be willing to refrain from caffeine- or xanthene-containing products (coffee, tea, cola, chocolate, etc.) for 48 hours prior to dosing in each period and through discharge from the study center.
- Subjects must be willing to refrain from strenuous exercise starting 72 hours prior to Day 1 of Period 1 through the Follow-up visit.
- Subjects must be willing to refrain from ingestion of alcohol starting 7 days (14 days for red wine) prior to Day 1 of Period 1 through the Follow-up visit.
- Subjects must agree not to donate blood or plasma to any blood bank or for any purpose (other than blood samples in this study) for the duration of participation in the study (from Screening to Follow-up).
Who cannot join
- Subjects who meet any of the following criteria will not be enrolled in the study:
- Subjects who have previously received AG-221 (this does not apply at Period 2).
- Subjects with Screening or Check-in clinical laboratory results that are outside the laboratory normal range, including hematology, clinical chemistry, serology, and urinalysis, that in the Investigator's judgment, is felt to be clinically relevant.
- Subjects who, after 10 minutes supine rest, have a systolic blood pressure (BP) >144 mmHg or a diastolic BP >90 mmHg. If BP exceeds these cut points related to transient anxiety-related increases, BP may be repeated once.
- Subjects with QTcF interval (Fridericia's correction factor) > 450 msec at Screening or pre dose on Day 1 of either study period.
- Subjects with a history of serious mental illness that includes, but is not limited to, schizophrenia, bipolar disorder, and major depression. Subjects with a history of depression may be included if treatment did not require hospitalization, if the subject has been off anti-depressant medication for a minimum of 12 months, and if in the Investigator's judgment, the subject has been stable with no evidence of significant depression for a minimum of 12 months.
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- Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, cardiovascular, hepatic, hematologic, lymphatic, neurologic, endocrine, psychiatric, musculoskeletal, genitourinary, immunologic, dermatologic, or connective tissue diseases or disorders.
- Subjects with a history of any primary malignancy, including a history of melanoma or suspicious undiagnosed skin lesions, with the exception of basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ or other malignancies curatively treated with no evidence of disease for at least 1 year prior to Screening.
- Subjects with a pre-existing condition that interferes with normal gastrointestinal anatomy or motility, and/or hepatic and/or renal function that could interfere with the absorption, metabolism, and/or excretion of the study drug. Note that cholecystectomy is not exclusionary.
- Subjects with any other medical or psychological condition, deemed by the Investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate, or participate in the study.
- Subjects who have undergone major surgery within 6 months prior to Screening.
- Subjects who test positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection 1 or 2.
- Subjects who have donated blood, had blood loss of more than 500 mL, or received transfusion of blood or plasma within 3 months prior to Screening.
- Subjects who have a history of illicit drug abuse or alcoholism within 12 months prior to Screening.
- Subjects who consume more than 21 units of alcohol a week (1 unit = 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of hard liquor).
- Subjects with a positive screen for drugs of abuse, or urinary cotinine >200 ng/mL at Screening or at Check-in; subjects with a positive screen for alcohol at Check-in.
- Subjects who are participating in any concurrent clinical trial of another investigational product or placebo, or have received an investigational agent within 2 months prior to Day 1 of Period 1.
- Subjects who have used prescription drugs within 2 weeks or 5 half-lives (whichever is longer) of dosing on Day 1 of Period 1.
- Subjects who have used over-the-counter (OTC) medication (excluding routine vitamins) within 7 days of dosing on Day 1 of Period 1, unless agreed as not clinically relevant by the Investigator and Sponsor's Medical Monitor. Note: use of acetaminophen up to doses no greater than 2 g in any 24 hour period up to 48 hours prior to study drug dosing is allowed.
- Subjects who have used St. John's Wort within 28 days before dosing on Day 1 of Period 1.
- Subjects who are unwilling to forgo consumption of red wine, Seville oranges, grapefruit or grapefruit juice and/or pomelos, exotic citrus fruits, or grapefruit hybrids from 14 days prior to dosing on Day 1 of Period 1 through the Follow-up visit.
- Subjects who are unwilling to forgo consumption of fruit juices, charbroiled meats, and vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts, mustard) from 7 days prior to dosing through discharge from the clinic in each period.
- Subjects who have undergone strenuous activity within 72 hours prior to Day 1 in each period.
- Subjects who are unable (e.g., food intolerance) or unwilling to consume a high-fat breakfast within 30 minutes.
- Subjects with a propensity for sunburn or other skin conditions making them unsuitable for the current study.
- Subjects who cannot communicate reliably with the Investigator.
- Subjects who cannot or are unlikely to cooperate with the requirements of the study (for example, difficulty with swallowing multiple tablets of medication).
- Subjects with any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject's participation in, or completion of, the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Two-Way Crossover Study to Assess the Pharmacokinetics and Safety of a Single Dose of AG-221 in Healthy Male Subjects When Administered Under Fed and Fasted Conditions
AG-221 is a first-in-class drug targeted specifically to inhibit the IDH2 enzyme. Small molecule inhibition of the IDH enzyme represents a new, targeted approach to cancer treatment.
Administration of oral drugs with food may change the absorption of drugs, and it is therefore useful to characterize the effect of food early in drug development.
- Conditions
- Healthy Volunteers
- Being tested
- AG221
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG221Drug
AG221 in fed and fasted conditions
| Study group | Role | What they receive |
|---|---|---|
| Treatment A (unfed) | Active comparator | Treatment A: Single oral dose of AG-221 mesylate at Hour 0 on Day 1, following a 10-hour overnight fast. Receives: Drug: AG221 |
| Treatment B (fed) | Active comparator | Treatment B: Single oral dose of AG-221 mesylate at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast. Receives: Drug: AG221 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) profile of AG-221
Serial blood sampling at specified time points for determination of plasma concentration-time profiles and PK parameters of AG-221.
Measured: Blood samples will be drawn prior to the single-dose administration of AG-221 (within 30 minutes) on Day 1 of each period, and at the following time points post dose: 1, 2, 3, 4, 6, 9, 12, 18, 24, 48, 96, 168, 240, 336, and 504 hours.
Incidence of adverse events
Measured: 105 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2014
- Study completionMar 2015
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agios Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Samuel Agresta, MD, MPH &TM, Study director, Agios Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218346
- Sponsor's protocol ID
- AG221-C-002
- Status last verified
- Dec 2015
- First submitted
- 13 Aug 2014
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Two-Way Crossover Study to Assess the Pharmacokinetics and Safety of a Single Dose of AG-221 in Healthy Male Subjects When Administered Under Fed and Fasted Conditions
- ClinicalTrials.gov ID
- NCT02218346
- Acronym / sponsor ID
- AG221-C-002
- Conditions
- Healthy Volunteers
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Agios Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celgene Corporation
- Study start
- Aug 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 18 Aug 2014 (estimated)
- 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.
AG-221 is a first-in-class drug targeted specifically to inhibit the IDH2 enzyme. Small molecule inhibition of the IDH enzyme represents a new, targeted approach to cancer treatment.
Administration of oral drugs with food may change the absorption of drugs, and it is therefore useful to characterize the effect of food early in drug development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A (unfed) | Active comparator | Drug: AG221Treatment A: Single oral dose of AG-221 mesylate at Hour 0 on Day 1, following a 10-hour overnight fast. |
| Treatment B (fed) | Active comparator | Drug: AG221Treatment B: Single oral dose of AG-221 mesylate at Hour 0 on Day 1, 30 minutes after the start of a high-fat breakfast. |
Who may qualify
- Ages
- 18 to 56 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy adult male subjects 18 to 56 years of age, inclusive, at Screening.
- Subjects who are able to understand and sign informed consent prior to the conduct of any protocol-specific screening procedures.
- Subjects must be willing and able to complete all study assessments and procedures.
- Subjects, with the exception of those who have undergone vasectomy at least 6 months prior to Screening, must agree to use condom with spermicide as contraception (regardless of their female partner's childbearing potential or their partner's use of their own contraception) from Day 1 of Period 1 until 28 days following the last dose of study drug.
- Subjects must have a body weight ≥50 kg and body mass index (BMI) ≥18.5 and ≤32 kg/m2 at Screening.
Key exclusion criteria (28 listed)
- Subjects who have previously received AG-221 (this does not apply at Period 2).
- Subjects with Screening or Check-in clinical laboratory results that are outside the laboratory normal range, including hematology, clinical chemistry, serology, and urinalysis, that in the Investigator's judgment, is felt to be clinically relevant.
- Subjects who, after 10 minutes supine rest, have a systolic blood pressure (BP) >144 mmHg or a diastolic BP >90 mmHg. If BP exceeds these cut points related to transient anxiety-related increases, BP may be repeated once.
- Subjects with QTcF interval (Fridericia's correction factor) > 450 msec at Screening or pre dose on Day 1 of either study period.
- Subjects with a history of serious mental illness that includes, but is not limited to, schizophrenia, bipolar disorder, and major depression. Subjects with a history of depression may be included if treatment did not require hospitalization, if the subject has been off anti-depressant medication for a minimum of 12 months, and if in the Investigator's judgment, the subject has been stable with no evidence of significant depression for a minimum of 12 months.
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 |
|---|---|---|
| AG221AG221 in fed and fasted conditions | Drug | Treatment A (unfed), Treatment B (fed) |
Primary outcome
Pharmacokinetic (PK) profile of AG-221
Time frame: Blood samples will be drawn prior to the single-dose administration of AG-221 (within 30 minutes) on Day 1 of each period, and at the following time points post dose: 1, 2, 3, 4, 6, 9, 12, 18, 24, 48, 96, 168, 240, 336, and 504 hours.
Serial blood sampling at specified time points for determination of plasma concentration-time profiles and PK parameters of AG-221.
Incidence of adverse events
Time frame: 105 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 14 Dec 2015.
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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.
Samuel Agresta, MD, MPH &TM study director
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 AG221 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 28 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 14 Dec 2015. 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?
Pharmacokinetic (PK) profile of AG-221 (time frame: Blood samples will be drawn prior to the single-dose administration of AG-221 (within 30 minutes) on Day 1 of each period, and at the following time points post dose: 1, 2, 3, 4, 6, 9, 12, 18, 24, 48, 96, 168, 240, 336, and 504 hours.). The study lists 2 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 14 Dec 2015.