Healthy VolunteersPhase 1NCT03703505

A Study to Evaluate the Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability of AG-348 in Healthy Male Participants Following Administration of a Single Oral Dose of [14C]AG-348 and Concomitant Single Intravenous Microdose of [13C6]AG-348

A Phase 1 study testing AG-348 and [13C6]AG-348 in people with Healthy Volunteers, 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

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Trial summary

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?: AG-348 and [13C6]AG-348
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 24 May 2018to 4 Jun 2018
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

Willing and able to provide voluntary written informed consent;
Males of any race between 18 and 55 years of age, inclusive;
Body mass index between 18.5 and 29.0 kilograms per meter squared (kg/m2), inclusive, and a total body weight between 50 and 100 kilograms (kg), inclusive;
In good health;
Participants will be surgically sterile for at least 90 days or, when sexually active with female partners of childbearing potential, will be required to use a male condom with spermicide from Check-in until 90 days after study drug administration. Sexual intercourse with female partners who are pregnant or breastfeeding should be avoided unless condoms are used from the time of study drug administration until 90 days after study drug administration. Male participants are required to refrain from donation of sperm from Check-in until 90 days after the last dose of study drug;
Participants who practice true abstinence, because of the participant's lifestyle choice (ie, the participant should not become abstinent just for the purpose of study participation), are exempt from contraceptive requirements. Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception. If a participant who is abstinent at the time of signing the informed consent form (ICF) becomes sexually active they must agree to use contraception as described previously;

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Participants who are exclusively in same-sex relationships, contraceptive requirements do not apply. If a participant who is in a same-sex relationship at the time of signing the ICF becomes engaged in a heterosexual relationship, they must agree to use contraception as described previously;
Willing and able to communicate verbally and in writing with the Investigator and to participate in all scheduled study procedures (including Follow-up procedures) and abide by the study restrictions;
Agrees to abstain from any alcohol consumption, starting 48 hours before Check-in and continuing until Discharge;
History of a minimum of 1 bowel movement per day.

Who cannot join

History of a medical or surgical condition that, in the opinion of the Investigator, may potentially interfere with study drug absorption, distribution, metabolism, and/or excretion (eg, participant has undergone gastrectomy, appendectomy, or cholecystectomy);
Undergone any major surgical procedure within the past 3 months;
After 5 minutes of rest in the supine position at Screening, has a systolic blood pressure (BP) reading of ≥140 mmHg (≥150 mmHg in participants >45 years of age) OR a diastolic BP reading of ≥90 mmHg;
Experienced any serious adverse reaction or serious hypersensitivity to any drug or its formulation excipients;
History of a primary malignancy, with the exception of a malignancy that has been curatively treated and for which the participant has displayed no evidence of disease within the past 3 years;
History of alcoholism or drug/chemical abuse within the past 2 years;

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Alcohol consumption of >21 units per week. One unit of alcohol equals 12 oz (360 mL) of beer, 1½ oz (45 mL) of liquor, or 5 oz (150 mL) of wine;
Positive urine drug screen at Screening or Check-in, or positive alcohol breath test at Check-in (confirmed by repeat);
Positive for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus;
Participation in a clinical study involving administration of an investigational product (IP) or new chemical entity (NCE) in the past 90 days, or 5 half-lives, if known, of the respective IP or NCE, whichever is longer;
Has taken, within the 14 days prior to Check-in, any of the following: prescription medication, over-the-counter medication, nonprescription preparation (including vitamins, minerals, phytotherapeutic/herbal/plant-derived preparations), or grapefruit products;
Has taken within the 28 days prior to Check-in, any restricted product known to strongly induce cytochrome P450 (CYP) 3A4 metabolism (eg, St. John's wort);
Is a current smoker or user of any other tobacco product, as confirmed by Screening and Check-in urine cotinine test OR has used any tobacco product within the past 3 months
Receipt of blood products within the past 2 months;
Donation of blood within the past 56 days, plasma within the past 2 weeks or platelets within the past 6 weeks;
Previously completed or withdrawn from this study or any other study investigating AG-348, and have previously received the IP;
Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures (eg, computed tomography scan, barium meal) exceeding 5 millisieverts (mSv) in the last 12 months or 10 mSv in the last 5 years, or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in;
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.
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 participate in this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance
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-348 in Healthy Male Subjects Following Administration of a Single Oral Dose of [14C]AG-348 and Concomitant Single Intravenous Microdose of [13C6]AG-348

This study will assess absorption, distribution, metabolism, excretion and absolute bioavailability of AG-348 in healthy male participants. Potential participants will be screened within 29 days prior to dose administration to determine eligibility. Eligible Participants will be admitted into the Clinical Research Unit (CRU) one day prior to administration of AG-348 and will be confined to the CRU until at least Day 8. If participants are not eligible for discharge on Day 8, they may remain in the CRU up to Day 11. Radiolabelled analytes of AG-348 will be administered in a single oral and intravenous (IV) dose on Day 1. Participants will be required to fast pre-dose, remain in a supine position for 1 hour post-dose and avoid water for 2 hours post-dose.

Conditions: Healthy Volunteers
Being tested: AG-348, [13C6]AG-348

What participants receive

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

AG-348Drug
120 milligrams (mg) oral capsule, single dose, contains 100 microcuries (μCi) of radio labelled [14C]AG-348.
[13C6]AG-348Drug
IV microdose of approximately 100 micrograms (mcg), single dose.

Study groups in NCT03703505
Study group	Role	What they receive
AG-348	Experimental	On Day 1, participants fasting for at least 10 hours the night before will receive oral AG-348 followed by intravenous (IV) [13C6]AG-348, 1 hour post-oral dose. Receives: Drug: AG-348; Drug: [13C6]AG-348

What is being measured

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

AG-348 Excreted Through Urine [A(eu)]
Measured: Pre-oral dose and 0-4 hours (hr), 4-8 hr, 8-12 hr, 12-24 hr, 24-36 hr, 36-48 hr, 48-72 hr, 72-96 hr, 96-120 hr, 120-144 hr and 168 hr post-oral dose
AG-348 Excreted through Feces [A(ef)]
Measured: Pre-oral dose and 0-24 hr, 24-48 hr, 48-72 hr, 72-96 hr, 96-120 hr, 120-144 hr and 168 hr post-oral dose
Total Amount Excreted Through Urine [Cumulative A(eu)] of AG-348
Measured: Pre-oral dose and 0-4 hours (hr), 4-8 hr, 8-12 hr, 12-24 hr, 24-36 hr, 36-48 hr, 48-72 hr, 72-96 hr, 96-120 hr, 120-144 hr and 168 hr post-oral dose
Total Amount Excreted Through Feces [Cumulative A(ef)] of AG-348
Measured: Pre-oral dose and 0-24 hr, 24-48 hr, 48-72 hr, 72-96 hr, 96-120 hr, 120-144 hr and 168 hr post-oral dose
Percentage Excreted in Urine [f(eu)] of AG-348
Measured: Pre-oral dose and 0-4 hours (hr), 4-8 hr, 8-12 hr, 12-24 hr, 24-36 hr, 36-48 hr, 48-72 hr, 72-96 hr, 96-120 hr, 120-144 hr and 168 hr post-oral dose
Percentage Excreted in Feces [f(ef)] of AG-348
Measured: Pre-oral dose and 0-24 hr, 24-48 hr, 48-72 hr, 72-96 hr, 96-120 hr, 120-144 hr and 168 hr post-oral dose
Renal Clearance [CL(R)] for AG-348
Measured: Pre-oral dose and 0-4 hours (hr), 4-8 hr, 8-12 hr, 12-24 hr, 24-36 hr, 36-48 hr, 48-72 hr, 72-96 hr, 96-120 hr, 120-144 hr and 168 hr post-oral dose
Percentage of Total Radioactivity in Total Excreta (Urine and Feces)
Measured: Pre-oral dose and 0-4 hours (hr), 4-8 hr, 8-12 hr, 12-24 hr, 24-36 hr, 36-48 hr, 48-72 hr, 72-96 hr, 96-120 hr, 120-144 hr and 168 hr post-oral dose
Area Under the Concentration-Time Curve From Time Zero to the Last Non-Zero Concentration [AUC(0- t)]
Measured: Pre-oral dose and 15 min, 30 min, 45 min, 60 min, 61 min, 62 min, 75 min, 90, min 105 min, 2 hr, 3hr, 4 hr, 6 hr, 8 hr, 10 hr, 12, hr 16, hr 24 hr, 36 hr, 48 hr and 72 hr post-oral dose
Area Under the Concentration-Time Curve From Time Zero to Infinity Concentration [AUC(0-inf)]
Measured: Pre-oral dose and 15 min, 30 min, 45 min, 60 min, 61 min, 62 min, 75 min, 90, min 105 min, 2 hr, 3hr, 4 hr, 6 hr, 8 hr, 10 hr, 12, hr 16, hr 24 hr, 36 hr, 48 hr and 72 hr post-oral dose
Maximum Observed Concentration (Cmax)
Measured: Pre-oral dose and 15 min, 30 min, 45 min, 60 min, 61 min, 62 min, 75 min, 90, min 105 min, 2 hr, 3hr, 4 hr, 6 hr, 8 hr, 10 hr, 12, hr 16, hr 24 hr, 36 hr, 48 hr and 72 hr post-oral dose
Time of Observed Cmax (Tmax)
Measured: Pre-oral dose and 15 min, 30 min, 45 min, 60 min, 61 min, 62 min, 75 min, 90, min 105 min, 2 hr, 3hr, 4 hr, 6 hr, 8 hr, 10 hr, 12, hr 16, hr 24 hr, 36 hr, 48 hr and 72 hr post-oral dose
Apparent Terminal Elimination Half-life [t(1/2)]
Measured: Pre-oral dose and 15 min, 30 min, 45 min, 60 min, 61 min, 62 min, 75 min, 90, min 105 min, 2 hr, 3hr, 4 hr, 6 hr, 8 hr, 10 hr, 12, hr 16, hr 24 hr, 36 hr, 48 hr and 72 hr post-oral dose
Ratio of [AUC(0-inf)] of Plasma AG-348 Relative to [AUC(0-inf)] of Plasma Total Radioactivity, [AUC(0-inf)] Plasma AG-348/Total Radioactivity Ratio
Measured: Pre-dose and 15, 30, 45, 61, and 90 min and 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, and 144, and 168 hr post-dose
Ratio of [AUC(0-inf)] of Whole Blood Total Radioactivity Relative to [AUC(0-inf)] of Plasma Total Radioactivity, [AUC(0-inf)] Blood/Plasma Ratio
Measured: Pre-dose and 15, 30, 45, 61, and 90 min and 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, and 144, and 168 hr post-dose
Total Clearance (CL) of [13C6]AG-348
Measured: Pre-oral dose and 15 min, 30 min, 45 min, 60 min, 61 min, 62 min, 75 min, 90, min 105 min, 2 hr, 3hr, 4 hr, 6 hr, 8 hr, 10 hr, 12, hr 16, hr 24 hr, 36 hr, 48 hr and 72 hr post-oral dose
Volume of Distribution [V(z)] of [13C6]AG-348
Measured: Pre-oral dose and 15 min, 30 min, 45 min, 60 min, 61 min, 62 min, 75 min, 90, min 105 min, 2 hr, 3hr, 4 hr, 6 hr, 8 hr, 10 hr, 12, hr 16, hr 24 hr, 36 hr, 48 hr and 72 hr post-oral dose
Volume of Distribution at Steady State [V(ss)] for [13C6]AG-348
Measured: Pre-oral dose and 15 min, 30 min, 45 min, 60 min, 61 min, 62 min, 75 min, 90, min 105 min, 2 hr, 3hr, 4 hr, 6 hr, 8 hr, 10 hr, 12, hr 16, hr 24 hr, 36 hr, 48 hr and 72 hr post-oral dose
Absolute Bioavailability (F) for AG-348
Measured: Pre-oral dose and 15 min, 30 min, 45 min, 60 min, 61 min, 62 min, 75 min, 90, min 105 min, 2 hr, 3hr, 4 hr, 6 hr, 8 hr, 10 hr, 12, hr 16, hr 24 hr, 36 hr, 48 hr and 72 hr post-oral dose
Plasma Concentrations of AG-348 Metabolites
Measured: Pre-dose and 30 min, 61 min, 2 hr, 4 hr, 8 hr, 12 hr, 24, hr, 48 hr, 72 hr, 120 hr and 168 hr post-oral dose

Secondary outcomes (3)

Concentration of AG-348 Metabolites in Urine
Measured: Pre-oral dose and 0-4 hours (hr), 4-8 hr, 8-12 hr, 12-24 hr, 24-36 hr, 36-48 hr, 48-72 hr, 72-96 hr, 96-120 hr, 120-144 hr and 168 hr post-oral dose
Concentration of AG-348 Metabolites in Feces
Measured: Pre-oral dose and 0-24 hr, 24-48 hr, 48-72 hr, 72-96 hr, 96-120 hr, 120-144 hr and 168 hr post-oral dose
Percentage of Participants Experiencing an Adverse Event
Measured: Screening to the end of study (up to 40 days)

Timeline

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

24 May 20184 Jun 2018

First posted12 Oct 2018
Study start24 May 2018
Primary completion1 Jun 2018
Study completion4 Jun 2018

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.
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: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03703505
Sponsor's protocol ID: AG348-C-009
Status last verified: Oct 2018
First submitted: 24 May 2018
Last updated: 12 Oct 2018
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: 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 12 Oct 2018. 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-348 in Healthy Male Subjects Following Administration of a Single Oral Dose of [14C]AG-348 and Concomitant Single Intravenous Microdose of [13C6]AG-348
ClinicalTrials.gov ID: NCT03703505
Acronym / sponsor ID: AG348-C-009
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: 24 May 2018 (actual)
Primary completion: 1 Jun 2018 (actual)
Study completion: 4 Jun 2018 (actual)
First posted: 12 Oct 2018 (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
AG-348	Experimental	Drug: AG-348, Drug: [13C6]AG-348On Day 1, participants fasting for at least 10 hours the night before will receive oral AG-348 followed by intravenous (IV) [13C6]AG-348, 1 hour post-oral dose.

Who may qualify

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

Key inclusion criteria (10 listed)

Willing and able to provide voluntary written informed consent;
Males of any race between 18 and 55 years of age, inclusive;
Body mass index between 18.5 and 29.0 kilograms per meter squared (kg/m2), inclusive, and a total body weight between 50 and 100 kilograms (kg), inclusive;
In good health;
Participants will be surgically sterile for at least 90 days or, when sexually active with female partners of childbearing potential, will be required to use a male condom with spermicide from Check-in until 90 days after study drug administration. Sexual intercourse with female partners who are pregnant or breastfeeding should be avoided unless condoms are used from the time of study drug administration until 90 days after study drug administration. Male participants are required to refrain from donation of sperm from Check-in until 90 days after the last dose of study drug;

Key exclusion criteria (20 listed)

History of a medical or surgical condition that, in the opinion of the Investigator, may potentially interfere with study drug absorption, distribution, metabolism, and/or excretion (eg, participant has undergone gastrectomy, appendectomy, or cholecystectomy);
Undergone any major surgical procedure within the past 3 months;
After 5 minutes of rest in the supine position at Screening, has a systolic blood pressure (BP) reading of ≥140 mmHg (≥150 mmHg in participants >45 years of age) OR a diastolic BP reading of ≥90 mmHg;
Experienced any serious adverse reaction or serious hypersensitivity to any drug or its formulation excipients;
History of a primary malignancy, with the exception of a malignancy that has been curatively treated and for which the participant has displayed no evidence of disease within the past 3 years;

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-348120 milligrams (mg) oral capsule, single dose, contains 100 microcuries (μCi) of radio labelled [14C]AG-348.	Drug	AG-348
[13C6]AG-348IV microdose of approximately 100 micrograms (mcg), single dose.	Drug	AG-348

Primary outcome

AG-348 Excreted Through Urine [A(eu)]
Time frame: Pre-oral dose and 0-4 hours (hr), 4-8 hr, 8-12 hr, 12-24 hr, 24-36 hr, 36-48 hr, 48-72 hr, 72-96 hr, 96-120 hr, 120-144 hr and 168 hr post-oral dose
AG-348 Excreted through Feces [A(ef)]
Time frame: Pre-oral dose and 0-24 hr, 24-48 hr, 48-72 hr, 72-96 hr, 96-120 hr, 120-144 hr and 168 hr post-oral dose
Total Amount Excreted Through Urine [Cumulative A(eu)] of AG-348
Time frame: Pre-oral dose and 0-4 hours (hr), 4-8 hr, 8-12 hr, 12-24 hr, 24-36 hr, 36-48 hr, 48-72 hr, 72-96 hr, 96-120 hr, 120-144 hr and 168 hr post-oral dose
Total Amount Excreted Through Feces [Cumulative A(ef)] of AG-348
Time frame: Pre-oral dose and 0-24 hr, 24-48 hr, 48-72 hr, 72-96 hr, 96-120 hr, 120-144 hr and 168 hr post-oral dose
Percentage Excreted in Urine [f(eu)] of AG-348
Time frame: Pre-oral dose and 0-4 hours (hr), 4-8 hr, 8-12 hr, 12-24 hr, 24-36 hr, 36-48 hr, 48-72 hr, 72-96 hr, 96-120 hr, 120-144 hr and 168 hr post-oral dose
Percentage Excreted in Feces [f(ef)] of AG-348
Time frame: Pre-oral dose and 0-24 hr, 24-48 hr, 48-72 hr, 72-96 hr, 96-120 hr, 120-144 hr and 168 hr post-oral dose
Renal Clearance [CL(R)] for AG-348
Time frame: Pre-oral dose and 0-4 hours (hr), 4-8 hr, 8-12 hr, 12-24 hr, 24-36 hr, 36-48 hr, 48-72 hr, 72-96 hr, 96-120 hr, 120-144 hr and 168 hr post-oral dose
Percentage of Total Radioactivity in Total Excreta (Urine and Feces)
Time frame: Pre-oral dose and 0-4 hours (hr), 4-8 hr, 8-12 hr, 12-24 hr, 24-36 hr, 36-48 hr, 48-72 hr, 72-96 hr, 96-120 hr, 120-144 hr and 168 hr post-oral dose
Area Under the Concentration-Time Curve From Time Zero to the Last Non-Zero Concentration [AUC(0- t)]
Time frame: Pre-oral dose and 15 min, 30 min, 45 min, 60 min, 61 min, 62 min, 75 min, 90, min 105 min, 2 hr, 3hr, 4 hr, 6 hr, 8 hr, 10 hr, 12, hr 16, hr 24 hr, 36 hr, 48 hr and 72 hr post-oral dose
Area Under the Concentration-Time Curve From Time Zero to Infinity Concentration [AUC(0-inf)]
Time frame: Pre-oral dose and 15 min, 30 min, 45 min, 60 min, 61 min, 62 min, 75 min, 90, min 105 min, 2 hr, 3hr, 4 hr, 6 hr, 8 hr, 10 hr, 12, hr 16, hr 24 hr, 36 hr, 48 hr and 72 hr post-oral dose
Maximum Observed Concentration (Cmax)
Time frame: Pre-oral dose and 15 min, 30 min, 45 min, 60 min, 61 min, 62 min, 75 min, 90, min 105 min, 2 hr, 3hr, 4 hr, 6 hr, 8 hr, 10 hr, 12, hr 16, hr 24 hr, 36 hr, 48 hr and 72 hr post-oral dose
Time of Observed Cmax (Tmax)
Time frame: Pre-oral dose and 15 min, 30 min, 45 min, 60 min, 61 min, 62 min, 75 min, 90, min 105 min, 2 hr, 3hr, 4 hr, 6 hr, 8 hr, 10 hr, 12, hr 16, hr 24 hr, 36 hr, 48 hr and 72 hr post-oral dose
Apparent Terminal Elimination Half-life [t(1/2)]
Time frame: Pre-oral dose and 15 min, 30 min, 45 min, 60 min, 61 min, 62 min, 75 min, 90, min 105 min, 2 hr, 3hr, 4 hr, 6 hr, 8 hr, 10 hr, 12, hr 16, hr 24 hr, 36 hr, 48 hr and 72 hr post-oral dose
Ratio of [AUC(0-inf)] of Plasma AG-348 Relative to [AUC(0-inf)] of Plasma Total Radioactivity, [AUC(0-inf)] Plasma AG-348/Total Radioactivity Ratio
Time frame: Pre-dose and 15, 30, 45, 61, and 90 min and 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, and 144, and 168 hr post-dose
Ratio of [AUC(0-inf)] of Whole Blood Total Radioactivity Relative to [AUC(0-inf)] of Plasma Total Radioactivity, [AUC(0-inf)] Blood/Plasma Ratio
Time frame: Pre-dose and 15, 30, 45, 61, and 90 min and 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, and 144, and 168 hr post-dose
Total Clearance (CL) of [13C6]AG-348
Time frame: Pre-oral dose and 15 min, 30 min, 45 min, 60 min, 61 min, 62 min, 75 min, 90, min 105 min, 2 hr, 3hr, 4 hr, 6 hr, 8 hr, 10 hr, 12, hr 16, hr 24 hr, 36 hr, 48 hr and 72 hr post-oral dose
Volume of Distribution [V(z)] of [13C6]AG-348
Time frame: Pre-oral dose and 15 min, 30 min, 45 min, 60 min, 61 min, 62 min, 75 min, 90, min 105 min, 2 hr, 3hr, 4 hr, 6 hr, 8 hr, 10 hr, 12, hr 16, hr 24 hr, 36 hr, 48 hr and 72 hr post-oral dose
Volume of Distribution at Steady State [V(ss)] for [13C6]AG-348
Time frame: Pre-oral dose and 15 min, 30 min, 45 min, 60 min, 61 min, 62 min, 75 min, 90, min 105 min, 2 hr, 3hr, 4 hr, 6 hr, 8 hr, 10 hr, 12, hr 16, hr 24 hr, 36 hr, 48 hr and 72 hr post-oral dose
Absolute Bioavailability (F) for AG-348
Time frame: Pre-oral dose and 15 min, 30 min, 45 min, 60 min, 61 min, 62 min, 75 min, 90, min 105 min, 2 hr, 3hr, 4 hr, 6 hr, 8 hr, 10 hr, 12, hr 16, hr 24 hr, 36 hr, 48 hr and 72 hr post-oral dose
Plasma Concentrations of AG-348 Metabolites
Time frame: Pre-dose and 30 min, 61 min, 2 hr, 4 hr, 8 hr, 12 hr, 24, hr, 48 hr, 72 hr, 120 hr and 168 hr post-oral dose

3 secondary outcomes

Concentration of AG-348 Metabolites in Urine
Time frame: Pre-oral dose and 0-4 hours (hr), 4-8 hr, 8-12 hr, 12-24 hr, 24-36 hr, 36-48 hr, 48-72 hr, 72-96 hr, 96-120 hr, 120-144 hr and 168 hr post-oral dose
Concentration of AG-348 Metabolites in Feces
Time frame: Pre-oral dose and 0-24 hr, 24-48 hr, 48-72 hr, 72-96 hr, 96-120 hr, 120-144 hr and 168 hr post-oral dose
Percentage of Participants Experiencing an Adverse Event
Time frame: Screening to the end of study (up to 40 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 12 Oct 2018.

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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-348 and [13C6]AG-348 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 10 inclusion and 20 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 12 Oct 2018. 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?

AG-348 Excreted Through Urine [A(eu)] (time frame: Pre-oral dose and 0-4 hours (hr), 4-8 hr, 8-12 hr, 12-24 hr, 24-36 hr, 36-48 hr, 48-72 hr, 72-96 hr, 96-120 hr, 120-144 hr and 168 hr post-oral dose). The study lists 20 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 NCT03703505.

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 12 Oct 2018.