- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02108106
A Phase I Study of AG-348 in Healthy Volunteers (AG-348 SAD)
October 21, 2014 updated by: Agios Pharmaceuticals, Inc.
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Safety, Pharmacokinetic and Pharmacodynamic Study of Orally Administered AG-348 in Healthy Volunteers
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21225
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AG-348
Single oral dose of AG-348
|
A range of doses of AG-348 will be tested based on assessment of safety and tolerability.
Other Names:
|
Placebo Comparator: Placebo
Single oral dose of placebo
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
11 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 days
|
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.
|
4 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
April 2, 2014
First Submitted That Met QC Criteria
April 4, 2014
First Posted (Estimate)
April 9, 2014
Study Record Updates
Last Update Posted (Estimate)
October 22, 2014
Last Update Submitted That Met QC Criteria
October 21, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- AG348-C-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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