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Trial record 5 of 13 for:    AG-348

A Phase I Study of AG-348 in Healthy Volunteers (AG-348 SAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02108106
Recruitment Status : Completed
First Posted : April 9, 2014
Last Update Posted : October 22, 2014
Information provided by (Responsible Party):
Agios Pharmaceuticals, Inc.

Brief Summary:
This is a dose escalation study that will be conducted in healthy volunteers. Multiple cohorts of volunteers will receive ascending oral doses of AG-348 to evaluate the safety and tolerability of a single oral dose of AG-348, the pharmacokinetics (PK) of a single dose of AG-348, and the pharmacodynamic profile of AG-348 with specific biomarkers assessed in the blood.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: AG-348 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Safety, Pharmacokinetic and Pharmacodynamic Study of Orally Administered AG-348 in Healthy Volunteers
Study Start Date : March 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
Experimental: AG-348
Single oral dose of AG-348
Drug: AG-348
A range of doses of AG-348 will be tested based on assessment of safety and tolerability.
Other Name: AG-348 will be administered as a single oral dose on Day 1.

Placebo Comparator: Placebo
Single oral dose of placebo
Drug: Placebo
Other Name: Placebo will be administered as a single oral dose on Day 1.

Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 11 days ]
    Incidence of adverse events and descriptive statistics for safety laboratory parameters, physical exam findings, vital signs and ECGs.

Secondary Outcome Measures :
  1. Pharmacokinetics of AG-348 [ Time Frame: 4 days ]
    Descriptive statistics will be used to summarize PK parameters of AG-348 for each dose group and, where appropriate, for the entire population. Standard non-compartmental PK parameters will be calculated from individual plasma concentration data.

  2. Pharmacodynamic (PD) relationship of AG-348 and metabolic biomarkers [ Time Frame: 4 days ]
    The potential relationship between AG-348 and metabolic biomarkers will be explored with descriptive and graphical methods. Details on the evaluation of exploratory analyses of pyruvate kinase (PKR) activity and other potential PD biomarkers will be described.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy adult male or female subjects 18 - 60 years, in good general health who are able to understand consent and complete all study procedures.
  • Female subjects of non-child bearing potential (surgically sterile or post-menopausal as confirmed by age [over 50 years], amenorrhea for 12 consecutive months and FSH).
  • Male subjects who are not vasectomized must agree to use contraception up to 30 days after dosing.
  • Subjects with body weight ≥50 kg; BMI ≥18.5 and ≤32 kg/m2.
  • Subjects who are 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 (chocolate) prior to dosing through 72 hours after dosing.
  • Subjects must agree to refrain from strenuous exercise prior to admission through final visit.
  • Subjects must refrain from use of alcohol starting 7 days prior to admission through final visit.
  • Subjects must agree not to donate blood products for duration of study participation.

Exclusion Criteria:

  • Subjects who have previously received AG-348.
  • Subjects with clinically relevant screening laboratory tests.
  • Female subjects of childbearing potential.
  • Male subjects with QTcF interval ECG > 450 msec,or female subjects with QTcF interval ECG > 470 msec.
  • Subjects with a history of a serious mental illness.
  • Subjects with a clinically relevant medical history or pre-existing medical condition that would interfere with the absorption, metabolism or excretion of the study drug.
  • Subjects with a history of any primary malignancy (cancer). Exceptions are certain skin cancers, cervical cancer in situ or other cancers that have been curatively treated without evidence of disease for a minimum of 1 year.
  • Subjects with glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
  • Subjects who are positive for hepatitis B, hepatitis C or HIV.
  • Subjects who have undergone surgery 6 months prior to screening.
  • Subjects who have a history of illicit drug use or alcoholism within the last year.
  • Subjects who are participating in other concurrent clinical trial of an investigational drug, or have received another investigational agent within the last 2 months.
  • Subjects with any conditions which would make the subject unsuitable for enrollment, or could interfere with the subject's participation in or completion of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02108106

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United States, Maryland
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Agios Pharmaceuticals, Inc.
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Study Director: Samuel Agresta, MD, MPH & TM Agios Pharmaceuticals, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Agios Pharmaceuticals, Inc. Identifier: NCT02108106    
Other Study ID Numbers: AG348-C-001
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: October 22, 2014
Last Verified: October 2014
Keywords provided by Agios Pharmaceuticals, Inc.:
safety and tolerability
pharmacokinetic study