Healthy VolunteersPhase 1NCT02489513
Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-AG-120
A Phase 1 study testing [14C]-AG-120 in people with Healthy Volunteers, run by Agios Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The study is designed to characterize the absorption, metabolism, and excretion of AG-120 using radiolabeled drug in healthy adult male subjects to support its further development and registration. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [14C]-AG-120
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Oct 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is a healthy adult male of any race and aged 18 to 55 years, inclusive, at the time of signing the Informed Consent Form (ICF)
- Understands and voluntarily signs an ICF before any study-related assessments/procedures are conducted
- Is willing and able to adhere to the study visit schedule and other protocol requirements
- Is willing to provide a blood sample for genotyping of CYP2D6 status at Screening
- Is either sterile or agrees to use contraception from Check-in until 90 days following dose administration. The approved methods of contraception include: male condom with spermicide (foam, gel, film, cream, or suppository); sterile sexual partner (eg, tubal occlusion, hysterectomy, or bilateral salpingectomy); or by female sexual partner, established use of hormonal contraceptives, use of an intrauterine device with copper or intrauterine system with progestogen, barrier contraceptive (condom, diaphragm, or cervical/vault caps) used with spermicide, or true abstinence; periodic abstinence (eg, calendar, ovulation, symptothermal post-ovulation methods) is not an acceptable method of contraception.
- Must have a body mass index between 18 and 33 kg/m2, inclusive, at Screening
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- Must be healthy as determined by the Investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG at Screening
- Must be afebrile (febrile is defined as ≥38.5°C or 101.3°F)
- Supine systolic blood pressure (BP) must be in the range of 90 to 140 mmHg, supine diastolic BP must be in the range of 50 to 90 mmHg, and pulse rate must be in the range of 40 to 110 beats per minute, as confirmed by repeat assessment if the initial vitals are out of range
- Normal or clinically acceptable 12-lead ECG, with a QT interval corrected using Fridericia's formula (QTcF) value ≤430 msec
- Calcium, magnesium, and potassium levels within normal ranges
Who cannot join
- History of any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
- Any condition, including the presence of clinically significant laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study
- Any condition that confounds the ability to interpret data
- Exposure to an investigational drug (new chemical entity) within 30 days preceding dose administration, or 5 half-lives of that investigational drug, if known (whichever is longer)
- Participation in more than 1 other radiolabeled investigational drug study within 12 months prior to Check-in (Day -1)
- Significant radiation exposure (eg, serial X-ray or computed tomography scans, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in (Day -1)
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- Prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc.) within 30 days of dose administration
- Nonprescription systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of dose administration
- Received a live vaccination within 90 days of dose administration
- Surgical or medical conditions possibly affecting absorption, distribution, metabolism, or excretion, (eg, bariatric procedure, or plans to have elective or medical procedures performed during the conduct of the trial). Prior appendectomy is acceptable, but prior cholecystectomy would result in exclusion from the study
- Blood or plasma donation within 8 weeks before dose administration to a blood bank or blood donation center
- History of drug abuse within 2 years before dose administration, or positive drug screening test reflecting consumption of illicit drugs
- History of alcohol abuse within 2 years before dose administration, or positive alcohol screen at Check-in
- Use of any tobacco- or nicotine-containing products (including but not limited to cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to Screening, or positive cotinine screen
- Known to be a carrier of hepatitis B surface antigen or hepatitis C virus antibody, or have a positive result to the test for human immunodeficiency virus (HIV) antibodies at screening
- Employed by the clinical site, or is related to an employee of the clinical site
- History of less than 1 bowel movement per day
- Standard dietary, fluid intake, and exercise restrictions are required as part of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-AG-120 Following Single Oral Dose Administration in Healthy Male Subjects
The study is designed to characterize the absorption, metabolism, and excretion of AG-120 using radiolabeled drug in healthy adult male subjects to support its further development and registration.
Read the detailed description
This will be a single-center, open-label, study in healthy adult males. Each subject will participate in a screening phase, a baseline phase, a treatment phase, and a follow up period. Subjects who have met all inclusion criteria and none of the exclusion criteria at screening will return to the clinical site on Day -1 for baseline assessments. Following a 10 hour overnight fast, subjects will receive a single 500mg dose of AG-120 suspension containing a microtracer of [14C] AG-120 (~ 200 μCi) under fasted conditions. The study drug will be administered as an oral suspension with approximately 240 mL of room temperature, non-carbonated water.
Blood, urine, and fecal samples (and vomitus, if applicable) will be collected throughout the study for pharmacokinetic (PK), mass balance, and/or clinical laboratory assessments. Safety will be monitored throughout the study. Subjects will be discharged from the clinical site from Day 22 to Day 29, depending on the recovery of eliminated radioactivity.
Urine and fecal samples will be collected each day until Day 29 (or the point of discharge if earlier) for measurement of total [14C] radioactivity. Blood samples for radioanalysis and PK assessment, inclusive of metabolite profiling/characterization, will be collected at pre-dose and at specified intervals through Day 29. Total [14C]-radioactivity in whole blood, plasma, urine, and feces (and vomitus, if applicable ) will be determined.
Up to 8 subjects will enroll in the study. One to two additional subjects who have been confirmed as having poor metabolizer (PM) CYP2D6 genotype may be enrolled.
- Conditions
- Healthy Volunteers
- Being tested
- [14C]-AG-120
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-AG-120Drug
Labeled investigational drug
| Study group | Role | What they receive |
|---|---|---|
| Single group assignment | Other | [14C]-AG-120 Receives: Drug: [14C]-AG-120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - Total [14C] Whole blood and plasma
Total [14C]-radioactivity in whole blood and plasmafollowing oral administration of a single 500-mg (approximately 200 μCi) radiolabeled dose of AG-120 in male subjects
Measured: up to 29 days
Pharmacokinetics of single dose of AG-120 (Cmax)
time of maximum observed drug concentration
Measured: up to 29 days
Pharmacokinetics of single dose of AG-120 (AUC)
Area under the curve
Measured: up to 29 days
Pharmacokinetics of single dose of AG-120 (t1/2)
Estimate of the terminal elimination half-life
Measured: up to 29 days
Pharmacokinetics - Total [14C] urine and feces
Total [14C]-radioactivity in urine, and feces (and vomitus, if applicable).
Measured: up to 29 days
Secondary outcomes (1)
AG120 Metabolite identification
Blood, urine, and fecal sample analysis to identify metabolites of AG-120
Measured: up to 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2015
- Study completionOct 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agios Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel Agresta, MD, MPH, Study chair, Agios Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489513
- Sponsor's protocol ID
- AG120-C-003
- Status last verified
- Dec 2015
- First submitted
- 1 Jul 2015
- 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, Open-label Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-AG-120 Following Single Oral Dose Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02489513
- Acronym / sponsor ID
- AG120-C-003
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Agios Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 3 Jul 2015 (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.
The study is designed to characterize the absorption, metabolism, and excretion of AG-120 using radiolabeled drug in healthy adult male subjects to support its further development and registration.
Detailed description
This will be a single-center, open-label, study in healthy adult males. Each subject will participate in a screening phase, a baseline phase, a treatment phase, and a follow up period. Subjects who have met all inclusion criteria and none of the exclusion criteria at screening will return to the clinical site on Day -1 for baseline assessments. Following a 10 hour overnight fast, subjects will receive a single 500mg dose of AG-120 suspension containing a microtracer of [14C] AG-120 (~ 200 μCi) under fasted conditions. The study drug will be administered as an oral suspension with approximately 240 mL of room temperature, non-carbonated water.
Blood, urine, and fecal samples (and vomitus, if applicable) will be collected throughout the study for pharmacokinetic (PK), mass balance, and/or clinical laboratory assessments. Safety will be monitored throughout the study. Subjects will be discharged from the clinical site from Day 22 to Day 29, depending on the recovery of eliminated radioactivity.
Urine and fecal samples will be collected each day until Day 29 (or the point of discharge if earlier) for measurement of total [14C] radioactivity. Blood samples for radioanalysis and PK assessment, inclusive of metabolite profiling/characterization, will be collected at pre-dose and at specified intervals through Day 29. Total [14C]-radioactivity in whole blood, plasma, urine, and feces (and vomitus, if applicable ) will be determined.
Up to 8 subjects will enroll in the study. One to two additional subjects who have been confirmed as having poor metabolizer (PM) CYP2D6 genotype may be enrolled.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group assignment | Other | Drug: [14C]-AG-120[14C]-AG-120 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Is a healthy adult male of any race and aged 18 to 55 years, inclusive, at the time of signing the Informed Consent Form (ICF)
- Understands and voluntarily signs an ICF before any study-related assessments/procedures are conducted
- Is willing and able to adhere to the study visit schedule and other protocol requirements
- Is willing to provide a blood sample for genotyping of CYP2D6 status at Screening
- Is either sterile or agrees to use contraception from Check-in until 90 days following dose administration. The approved methods of contraception include: male condom with spermicide (foam, gel, film, cream, or suppository); sterile sexual partner (eg, tubal occlusion, hysterectomy, or bilateral salpingectomy); or by female sexual partner, established use of hormonal contraceptives, use of an intrauterine device with copper or intrauterine system with progestogen, barrier contraceptive (condom, diaphragm, or cervical/vault caps) used with spermicide, or true abstinence; periodic abstinence (eg, calendar, ovulation, symptothermal post-ovulation methods) is not an acceptable method of contraception.
Key exclusion criteria (18 listed)
- History of any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
- Any condition, including the presence of clinically significant laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study
- Any condition that confounds the ability to interpret data
- Exposure to an investigational drug (new chemical entity) within 30 days preceding dose administration, or 5 half-lives of that investigational drug, if known (whichever is longer)
- Participation in more than 1 other radiolabeled investigational drug study within 12 months prior to Check-in (Day -1)
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 |
|---|---|---|
| [14C]-AG-120Labeled investigational drug | Drug | Single group assignment |
Primary outcome
Pharmacokinetics - Total [14C] Whole blood and plasma
Time frame: up to 29 days
Total [14C]-radioactivity in whole blood and plasmafollowing oral administration of a single 500-mg (approximately 200 μCi) radiolabeled dose of AG-120 in male subjects
Pharmacokinetics of single dose of AG-120 (Cmax)
Time frame: up to 29 days
time of maximum observed drug concentration
Pharmacokinetics of single dose of AG-120 (AUC)
Time frame: up to 29 days
Area under the curve
Pharmacokinetics of single dose of AG-120 (t1/2)
Time frame: up to 29 days
Estimate of the terminal elimination half-life
Pharmacokinetics - Total [14C] urine and feces
Time frame: up to 29 days
Total [14C]-radioactivity in urine, and feces (and vomitus, if applicable).
1 secondary outcome
AG120 Metabolite identification
Time frame: up to 29 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 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 [14C]-AG-120 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 18 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?
Pharmacokinetics - Total [14C] Whole blood and plasma (time frame: up to 29 days). The study lists 5 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.