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 |
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.
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
Click here to add this to my saved trials