A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Pharmacokinetic, and Pharmacodynamic Study of Orally Administered AG-348 in Healthy Volunteers

Agios Pharmaceuticals, Inc.0 sites48 target enrollmentMay 2014

ConditionsHealthy Volunteer

InterventionsAG-348 Placebo

DrugsAG-348 Placebo

Overview

Phase: Phase 1
Intervention: AG-348
Conditions: Healthy Volunteer
Sponsor: Agios Pharmaceuticals, Inc.
Enrollment: 48
Primary Endpoint: Incidence of adverse events
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a dose escalation study that will be conducted in healthy volunteers. Multiple cohorts of volunteers will receive ascending (increasingly higher) oral doses of AG-348 daily for 14 days to evaluate the safety and tolerability of multiple oral doses of AG-348, the pharmacokinetics (PK) of multiple doses of AG-348, and the pharmacodynamic profile of AG-348 with specific biomarkers assessed in the blood.

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

November 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Agios Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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/m
•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 (coffee, tea, chocolate) for 48 hours prior to dosing through discharge from the clinical facility.
•Subjects must agree to refrain from strenuous exercise starting 72 hours prior to admission through final follow-up visit.
•Subjects must refrain from use of alcohol starting 7 days (14 days for red wine) prior to admission through final follow-up visit.
•Subjects must agree not to donate blood products for duration of study participation.

Exclusion Criteria

•Subjects who have previously received AG-
•Subjects with clinically relevant screening laboratory tests.
•Female subjects who are not post-menopausal.
•Subjects with recent use of prescription, over the counter (OTC), herbal and/or dietary medications and/or supplements.
•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.