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

Completed · Phase 1

Conditions studied: NASH - Nonalcoholic Steatohepatitis

In brief

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.

Key facts

Study ID

NCT03748628

Run by

Enanta Pharmaceuticals, Inc

People needed

8

Starts

2018-10-05

Expected to finish

2018-10-13

Last updated by the study team

2018-11-21

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Covance Clinical Research Unit — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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