A Phase I Study of AG-348 in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 11/8/2014 |
| Start Date: | May 2014 |
| End Date: | October 2014 |
| Contact: | Elizabeth Merica |
| Email: | elizabeth.merica@agios.com |
| Phone: | 617-649-2034 |
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Pharmacokinetic, and Pharmacodynamic Study of Orally Administered AG-348 in Healthy Volunteers
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.
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.
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.
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