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

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

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: N/A
• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Wisconsin

Covance Clinical Research Unit

Madison, Wisconsin, United States, 53704

Sponsors and Collaborators

Enanta Pharmaceuticals

Investigators

• Study Director: Enanta Pharmaceuticals, Inc; Enanta Pharmaceuticals, Inc

More Information

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

• 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:

Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Diseases; Digestive System Diseases