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

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ClinicalTrials.gov Identifier: NCT03748628
Recruitment Status : Completed
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Enanta Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
NASH - Nonalcoholic Steatohepatitis Drug: EDP-305 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : October 5, 2018
Actual Primary Completion Date : October 13, 2018
Actual Study Completion Date : October 13, 2018


Arm Intervention/treatment
Experimental: Single arm EDP-305 Drug: EDP-305
[14C]EDP-305




Primary Outcome Measures :
  1. Cmax of EDP-305 in plasma [ Time Frame: Up to 9 days ]
  2. AUC of EDP-305 in plasma [ Time Frame: Up to 9 days ]
  3. AUC-inf in plasma [ Time Frame: Up to 9 days ]

Secondary Outcome Measures :
  1. Amount excreted in urine (Aeu) [ Time Frame: Up to 9 days ]
  2. Amount excreted in feces (Aef) [ Time Frame: Up to 9 days ]
  3. Safety measured by adverse events [ Time Frame: Up to 9 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748628


Locations
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United States, Wisconsin
Covance Clinical Research Unit
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Enanta Pharmaceuticals
Investigators
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Study Director: Enanta Pharmaceuticals, Inc Enanta Pharmaceuticals, Inc

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Responsible Party: Enanta Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03748628     History of Changes
Other Study ID Numbers: EDP 305-009
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Enanta Pharmaceuticals:
AME Study

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases