Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 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.
 
ClinicalTrials.gov Identifier: NCT02108106
Recruitment Status : Completed
First Posted : April 9, 2014
Last Update Posted : October 22, 2014
Sponsor:
Information provided by (Responsible Party):
Agios Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE April 2, 2014
First Posted Date  ICMJE April 9, 2014
Last Update Posted Date October 22, 2014
Study Start Date  ICMJE March 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02108106 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2014)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase I Study of AG-348 in Healthy Volunteers
Official Title  ICMJE A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Safety, Pharmacokinetic and Pharmacodynamic Study of Orally Administered AG-348 in Healthy Volunteers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteer
Intervention  ICMJE
  • 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.
  • Drug: Placebo
    Other Name: Placebo will be administered as a single oral dose on Day 1.
Study Arms  ICMJE
  • Experimental: AG-348
    Single oral dose of AG-348
    Intervention: Drug: AG-348
  • Placebo Comparator: Placebo
    Single oral dose of placebo
    Intervention: Drug: Placebo
Publications * Yang H, Merica E, Chen Y, Cohen M, Goldwater R, Kosinski PA, Kung C, Yuan ZJ, Silverman L, Goldwasser M, Silver BA, Agresta S, Barbier AJ. Phase 1 Single- and Multiple-Ascending-Dose Randomized Studies of the Safety, Pharmacokinetics, and Pharmacodynamics of AG-348, a First-in-Class Allosteric Activator of Pyruvate Kinase R, in Healthy Volunteers. Clin Pharmacol Drug Dev. 2019 Feb;8(2):246-259. doi: 10.1002/cpdd.604. Epub 2018 Aug 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2014)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02108106
Other Study ID Numbers  ICMJE AG348-C-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Agios Pharmaceuticals, Inc.
Study Sponsor  ICMJE Agios Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Samuel Agresta, MD, MPH & TM Agios Pharmaceuticals, Inc.
PRS Account Agios Pharmaceuticals, Inc.
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP