Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male Subjects



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 55
Updated:11/23/2018
Start Date:October 5, 2018
End Date:October 13, 2018

Use our guide to learn which trials are right for you!

A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]EDP-305 Following a Single Oral Dose in Healthy Male Subjects

A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral
dose of [14C]EDP-305 in healthy male subjects.


Inclusion Criteria:

- Healthy male subjects aged between 18 and 55 years (inclusive) with a body mass index
between 18.0 and 32.0 kg/m2 (inclusive)

- able to comprehend and willing to sign an Informed Consent Form

- In good health, determined by no clinically significant findings from medical history,
physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory
evaluations.

Exclusion Criteria:

- Significant history or clinical manifestation of any metabolic, allergic,
dermatological, hepatic, renal, hematological, pulmonary, cardiovascular,
gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as
determined by the Investigator (or designee).

- History of stomach or intestinal surgery or resection that would potentially alter
absorption and/or excretion of orally administered drugs (including gastrectomy and
cholecystectomy; uncomplicated appendectomy and hernia repair will be allowed).

- Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to
Screening, or platelets from 6 weeks prior to Screening.
We found this trial at
1
site
Madison, Wisconsin 53718
?
mi
from
Madison, WI
Click here to add this to my saved trials