Healthy Male ParticipantsPhase 1NCT03960502

A Safety and Pharmacokinetic Study of AG-881 in Healthy Male Participants Following Administration of a Single Oral Dose of [14C] AG-881 and Concomitant Intravenous Microdose of [13C315N3] AG-881

A Phase 1 study testing AG-881 and [13C315N3]AG-881 in people with Healthy Male Participants, run by Agios Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this Phase I, open-label study is to evaluate the absorption, distribution, metabolism, excretion, absolute bioavailability, and to characterize the metabolites of AG-881 in healthy male participants following administration of a single oral dose of [14C] AG-881 and a concomitant intravenous microdose… 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 Male Participants
What is being tested?: AG-881 and [13C315N3]AG-881
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 16 May 2019to 7 Sep 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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions, including confinement, as well as adhere to all study procedures;
Males of any race, between 18 and 55 years of age, inclusive;
Body mass index between 18.0 and 32.0 kilograms per meter squared (kg/m^2), inclusive, and a total body weight between 50 and 100 kg, inclusive;
In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations (congenital non-hemolytic hyperbilirubinemia [e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at Screening and/or Check-in (Day -1), as assessed by the Investigator (or designee);
Alanine aminotransferase (ALT; at or within normal limits [WNL]), aspartate aminotransferase (AST; at or within normal limits), alkaline phosphatase (ALP; <1.5 × upper limit of normal [ULN]), bilirubin (at or below WNL). One repeat assessment allowed at each time point;
Male participants will agree to use contraception;

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Agrees to abstain from any alcohol consumption, starting 48 hours before Check-in (Day -1) and continuing until Discharge;
History of a minimum of one bowel movement per day;
Adequate peripheral venous access.

Who cannot join

Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee);
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee);
History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed);
Has undergone any major surgical procedure within the 3 months prior to Screening;
History of alcoholism or drug/chemical abuse within 2 years prior to Check-in (Day -1);
History of severe and/or uncontrolled ventricular arrhythmias or other factors that increase the risk of long QT syndrome, or use, or intend to use, medications that are known to prolong the QT interval or history of unexplained syncopal events or familial history of unexplained death in young person;

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After at least 5 minutes of rest in the supine position at Screening, has a systolic blood pressure reading of ≥140 millimeters of mercury (mmHg) OR a diastolic blood pressure reading of ≥90 mmHg;
A heart rate-corrected QT interval by Fridericia's (QTcF) method of ≥450 milliseconds (ms);
Alcohol consumption of >21 units per week. One unit of alcohol equals 12 ounces (360 millimeters [mL]) of beer, 1½ oz (45 mL) of liquor, or 5 oz (150 mL) of wine;
Positive urine drug screen at Screening or positive alcohol breath test result or positive urine drug screen at Check-in (Day -1);
Positive hepatitis panel and/or positive human immunodeficiency virus test;
Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (whichever is longer), prior to dosing;
Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to Check-in (Day -1), unless deemed acceptable by the Investigator (or designee);
Use or intend to use any prescription medications/products within 14 days prior to Check-in (Day -1), unless deemed acceptable by the Investigator (or designee);
Use or intend to use slow-release medications/products considered to still be active within 30 days prior to Check-in (Day -1), unless deemed acceptable by the Investigator (or designee);
Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to Check-in (Day -1), unless deemed acceptable by the Investigator (or designee);
Use of tobacco- or nicotine-containing products within 3 months prior to Check-in (Day -1), or positive cotinine at Screening or Check-in (Day -1);
Receipt of blood products within 2 months prior to Check-in (Day -1);
Donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening;
Have previously completed or withdrawn from this study or any other study investigating AG-881, and have previously received the investigational product;
Participants with exposure to significant diagnostic or therapeutic radiation (e.g., serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in (Day -1);
Participants who have participated in a radiolabeled drug study where exposures are known to the Investigator within the previous 4 months prior to admission to the clinic for this study or participated in a radiolabeled drug study where exposures are not known to the Investigator within the previous 6 months prior to admission to the clinic for this study. The total 12-month exposure from this study and a maximum of 2 other previous radiolabeled studies within 4 to 12 months prior to this study will be within the Code of Federal Regulations (CFR) recommended levels considered safe, per United States (US) Title 21 CFR 361.1: less than 5,000 millirems (mrem) whole-body annual exposure with consideration given to the half-lives of the previous radiolabeled study drugs received;
Is an employee of, or an immediate family member of an employee of, the study site or the Sponsor;
Participants who, in the opinion of the Investigator (or designee), should not be part of this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance Clinical Research Unit Inc.
Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: A Phase I, Open-label Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion, and to Assess the Absolute Bioavailability of AG-881 in Healthy Male Subjects Following Administration of a Single Oral Dose of [14C] AG-881 and Concomitant Intravenous Microdose of [13C315N3] AG-881

Conditions: Healthy Male Participants
Being tested: AG-881, [13C315N3]AG-881
Keywords: Safety and tolerability, Pharmacokinetic study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AG-881Drug
Single oral dose of approximately 50 mg AG-881 (free form) containing approximately 100 microcuries (μCi) of [14C]AG-881.
[13C315N3]AG-881Drug
Single IV microdose of approximately 100 μg.

Study groups in NCT03960502
Study group	Role	What they receive
AG881	Experimental	On Day 1, after fasting for 10 hours participants, will receive an oral capsule of [14C]AG-881 followed 2 hours later by a single intravenous (IV) infusion of [13C315N3]AG-881. Receives: Drug: AG-881; Drug: [13C315N3]AG-881

What is being measured

The primary outcome is the main question the study is designed to answer.

Amount of AG-881 Excreted in Urine (Aeu)
Measured: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Cumulative Aeu (Cum Aeu) of AG-881
Measured: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Percentage of AG-881 excreted in Urine and Feces (feu and fef, Respectively)
Measured: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Cumulative Percentage of AG-881 Excreted in Urine (Cum feu)
Measured: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Cumulative Percentage of AG-881 Excreted in Feces (Cum fef)
Measured: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Renal Clearance (CLR) of AG-881
Measured: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Renal Clearance Expressed as a Percentage of Total Clearance (CLR/CL) of AG-881
Measured: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Percentage of Total Radioactivity in Total Excreta Calculated as Cumulative Percentage of AG-881 Excreted in Urine and Feces (Cum fe)
Measured: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Area Under the Concentration-time Curve from Time Zero to the Last Measurable Concentration (AUC0-last) of AG-881
Measured: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Area Under the Concentration-time Curve from Time Zero to 72 hours (AUC0-72) of AG-881
Measured: Up to 72 hours
Partial Area Under the Concentration-time Curve from Time Zero to Common Time Point (AUC0-t) of AG-881
Measured: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Area Under the Concentration-time Curve from Time Zero to Infinity (AUC0-∞) of AG-881 Calculated Using the Observed Value of the Last Quantifiable Concentration
Measured: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Maximum Observed Plasma Concentration (Cmax) of AG-881
Measured: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Time to Maximum Observed Plasma Concentration (Tmax) of AG-881
Measured: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Apparent Terminal Elimination Half-life (t½) of AG-881
Measured: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
AUC0-∞ or AUC0-t of AG-881 in Plasma/AUC0-∞ or AUC0-t of Total Radioactivity in Plasma (AUC Plasma AG-881/Total Radioactivity Ratio)
Measured: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
AUC0-∞ of Total Radioactivity in Whole Blood to AUC0-∞ of Total Radioactivity in Plasma (AUC Blood/Plasma Ratio), Calculated Using the Observed Value of the Last Quantifiable Concentration
Measured: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Total Clearance of AG-881 Following Intravenous (IV) Administration (CL)
Measured: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Apparent Clearance Following Oral Administration of AG-881 (CL/F)
Measured: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Volume of Distribution of AG-881 at Steady-state Following IV Administration (Vss)
Measured: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Apparent Volume of Distribution During the Terminal Phase Following Oral Administration of AG-881 (Vz/F)
Measured: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Absolute bioavailability (F) for AG-881 Calculated as the Ratio of Dose-normalized AUC0-∞ of Oral/Intravenous Dosing
Measured: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Metabolic Profiles of AG-881 in Plasma, Urine, and Feces, When Possible
Measured: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Structures of AG-881 Metabolites in Plasma, Urine, and, Where Possible, Feces
Measured: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks

Secondary outcomes (5)

Percentage of Participants with Adverse Events (AEs), Graded by Severity
AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; Version 4.03)
Measured: Up to approximately 12 weeks
Percentage of Participants with Laboratory Abnormalities
Laboratory assessments will include parameters assessing clinical chemistry, hematology, coagulation, urinalysis, and serology.
Measured: Up to approximately 8 weeks
Percentage of Participants with Abnormalities in 12-lead Electrocardiogram (ECG)
Measured: Up to approximately 8 weeks
Percentage of Participants with Abnormalities in Vital Signs Measurements
Vital signs will include supine blood pressure, supine pulse rate, and oral body temperature.
Measured: Up to approximately 8 weeks
Percentage of Participants with Abnormalities in Physical Examinations
Measured: Up to approximately 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 May 20197 Sep 2019

First posted23 May 2019
Study start16 May 2019
Primary completion7 Sep 2019
Study completion7 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy Male ParticipantsStudies 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: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03960502
Sponsor's protocol ID: AG881-C-005
Status last verified: Oct 2019
First submitted: 21 May 2019
Last updated: 23 Oct 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open-label Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion, and to Assess the Absolute Bioavailability of AG-881 in Healthy Male Subjects Following Administration of a Single Oral Dose of [14C] AG-881 and Concomitant Intravenous Microdose of [13C315N3] AG-881
ClinicalTrials.gov ID: NCT03960502
Acronym / sponsor ID: AG881-C-005
Conditions: Healthy Male Participants
Keywords: Safety and tolerability, Pharmacokinetic study
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: Agios Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 16 May 2019 (actual)
Primary completion: 7 Sep 2019 (actual)
Study completion: 7 Sep 2019 (actual)
First posted: 23 May 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.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AG881	Experimental	Drug: AG-881, Drug: [13C315N3]AG-881On Day 1, after fasting for 10 hours participants, will receive an oral capsule of [14C]AG-881 followed 2 hours later by a single intravenous (IV) infusion of [13C315N3]AG-881.

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions, including confinement, as well as adhere to all study procedures;
Males of any race, between 18 and 55 years of age, inclusive;
Body mass index between 18.0 and 32.0 kilograms per meter squared (kg/m^2), inclusive, and a total body weight between 50 and 100 kg, inclusive;
In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations (congenital non-hemolytic hyperbilirubinemia [e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at Screening and/or Check-in (Day -1), as assessed by the Investigator (or designee);
Alanine aminotransferase (ALT; at or within normal limits [WNL]), aspartate aminotransferase (AST; at or within normal limits), alkaline phosphatase (ALP; <1.5 × upper limit of normal [ULN]), bilirubin (at or below WNL). One repeat assessment allowed at each time point;

Key exclusion criteria (24 listed)

Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee);
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee);
History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed);
Has undergone any major surgical procedure within the 3 months prior to Screening;
History of alcoholism or drug/chemical abuse within 2 years 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
AG-881Single oral dose of approximately 50 mg AG-881 (free form) containing approximately 100 microcuries (μCi) of [14C]AG-881.	Drug	AG881
[13C315N3]AG-881Single IV microdose of approximately 100 μg.	Drug	AG881

Primary outcome

Amount of AG-881 Excreted in Urine (Aeu)
Time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Cumulative Aeu (Cum Aeu) of AG-881
Time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Percentage of AG-881 excreted in Urine and Feces (feu and fef, Respectively)
Time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Cumulative Percentage of AG-881 Excreted in Urine (Cum feu)
Time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Cumulative Percentage of AG-881 Excreted in Feces (Cum fef)
Time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Renal Clearance (CLR) of AG-881
Time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Renal Clearance Expressed as a Percentage of Total Clearance (CLR/CL) of AG-881
Time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Percentage of Total Radioactivity in Total Excreta Calculated as Cumulative Percentage of AG-881 Excreted in Urine and Feces (Cum fe)
Time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Area Under the Concentration-time Curve from Time Zero to the Last Measurable Concentration (AUC0-last) of AG-881
Time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Area Under the Concentration-time Curve from Time Zero to 72 hours (AUC0-72) of AG-881
Time frame: Up to 72 hours
Partial Area Under the Concentration-time Curve from Time Zero to Common Time Point (AUC0-t) of AG-881
Time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Area Under the Concentration-time Curve from Time Zero to Infinity (AUC0-∞) of AG-881 Calculated Using the Observed Value of the Last Quantifiable Concentration
Time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Maximum Observed Plasma Concentration (Cmax) of AG-881
Time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Time to Maximum Observed Plasma Concentration (Tmax) of AG-881
Time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Apparent Terminal Elimination Half-life (t½) of AG-881
Time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
AUC0-∞ or AUC0-t of AG-881 in Plasma/AUC0-∞ or AUC0-t of Total Radioactivity in Plasma (AUC Plasma AG-881/Total Radioactivity Ratio)
Time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
AUC0-∞ of Total Radioactivity in Whole Blood to AUC0-∞ of Total Radioactivity in Plasma (AUC Blood/Plasma Ratio), Calculated Using the Observed Value of the Last Quantifiable Concentration
Time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Total Clearance of AG-881 Following Intravenous (IV) Administration (CL)
Time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Apparent Clearance Following Oral Administration of AG-881 (CL/F)
Time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Volume of Distribution of AG-881 at Steady-state Following IV Administration (Vss)
Time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Apparent Volume of Distribution During the Terminal Phase Following Oral Administration of AG-881 (Vz/F)
Time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Absolute bioavailability (F) for AG-881 Calculated as the Ratio of Dose-normalized AUC0-∞ of Oral/Intravenous Dosing
Time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Metabolic Profiles of AG-881 in Plasma, Urine, and Feces, When Possible
Time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks
Structures of AG-881 Metabolites in Plasma, Urine, and, Where Possible, Feces
Time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks

5 secondary outcomes

Percentage of Participants with Adverse Events (AEs), Graded by Severity
Time frame: Up to approximately 12 weeks
Percentage of Participants with Laboratory Abnormalities
Time frame: Up to approximately 8 weeks
Percentage of Participants with Abnormalities in 12-lead Electrocardiogram (ECG)
Time frame: Up to approximately 8 weeks
Percentage of Participants with Abnormalities in Vital Signs Measurements
Time frame: Up to approximately 8 weeks
Percentage of Participants with Abnormalities in Physical Examinations
Time frame: Up to approximately 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
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 AG-881 and [13C315N3]AG-881 in people with Healthy Male Participants, 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 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2019. 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?

Amount of AG-881 Excreted in Urine (Aeu) (time frame: At multiple time points daily from Day -1 to Day 14; then at 24-hour intervals until discharge (up to 29 days); then weekly up to approximately 8 weeks). The study lists 24 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 NCT03960502.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.