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
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteer||Drug: AG-348 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Single oral dose of 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
Other Name: Placebo will be administered as a single oral dose on Day 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02108106
|United States, Maryland|
|Baltimore, Maryland, United States, 21225|
|Study Director:||Samuel Agresta, MD, MPH & TM||Agios Pharmaceuticals, Inc.|