Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT02149966
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/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 (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-348.
* 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.
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02149966
Study Brief:
Protocol Section:
NCT02149966