Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Agios Pharmaceuticals, Inc.
Age
18–60
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | A Phase I Study of AG-348 in Healthy Volunteers
