Expired Study
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Madison, Wisconsin 53704


Purpose:

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.


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.


Study is Available At:


Original ID:

EDP 305-009


NCT ID:

NCT03748628


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Enanta Pharmaceuticals


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

8


Enrollment Type:

Actual


Overall Contact Information

Official Name:Enanta Pharmaceuticals, Inc
Study Director
Enanta Pharmaceuticals, Inc

Study Dates

Start Date:October 5, 2018
Completion Date:October 13, 2018
Completion Type:Actual
Primary Completion Date:October 13, 2018
Primary Completion Type:Actual
Verification Date:October 2018
Last Changed Date:November 18, 2018
First Received Date:October 31, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Safety measured by adverse events
Time Frame:Up to 9 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Amount excreted in feces (Aef)
Time Frame:Up to 9 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Amount excreted in urine (Aeu)
Time Frame:Up to 9 days
Safety Issues:False
Outcome Type:Primary Outcome
Measure:AUC-inf in plasma
Time Frame:Up to 9 days
Safety Issues:False
Outcome Type:Primary Outcome
Measure:AUC of EDP-305 in plasma
Time Frame:Up to 9 days
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Cmax of EDP-305 in plasma
Time Frame:Up to 9 days
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:EDP-305
Description:[14C]EDP-305
Arm Name:Single arm EDP-305

Study Arms

Study Arm Type:Experimental
Arm Name:Single arm EDP-305

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Enanta Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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