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OpenTrials
Completed

NCT Number: NCT03748628

Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 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.

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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EDP-305

Drug

[14C]EDP-305

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Enanta Pharmaceuticals, Inc

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 21, 2018
Registry last updated
Nov 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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