A Phase I Study of AG-348 in Healthy Volunteers (AG-348MAD)
|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: NCT02149966|
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : November 10, 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 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Pharmacokinetic, and Pharmacodynamic Study of Orally Administered AG-348 in Healthy Volunteers|
|Study Start Date :||May 2014|
|Primary Completion Date :||November 2014|
|Study Completion Date :||November 2014|
Multiple oral doses of AG-348
A range of doses of AG-348 will be tested based on the assessment of safety and tolerability. AG-348 will be administered by mouth (orally) each day for a period of 14 days.
Placebo Comparator: Placebo
Multiple oral doses of placebo.
Placebo will be administered by mouth (orally) each day for a period of 14 days.
- Incidence of adverse events [ Time Frame: 29 days ]
- Pharmacokinetics parameters of AG-348 [ Time Frame: 17 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: 17 days ]The potential relationship between AG-348 and metabolic biomarkers will be explored with descriptive and graphical methods. Details on the evaluation 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): NCT02149966
|United States, Maryland|
|Baltimore,, Maryland, United States, 21225|
|Study Director:||Samuel Agresta, MD, MPH & TM||Agios Pharmaceuticals, Inc.|