Evaluation of the Safety and Pharmacokinetics of a Single... | NCT01999725

Studies
Evaluation of the Safety and Pharmacokinetics of a Single Oral Dose of EDP-788

NCT01999725

Sponsor

Enanta Pharmaceuticals, Inc

Status

Completed

Last Update Posted

Jan 9, 2015Estimated

Enrollment

80Actual

Phase

Phase 1

Conditions

Safety in Normal Volunteers

Interventions

EDP-788
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Nov 25, 2013

First Submission Date that Met QC Criteria

Nov 26, 2013

First Posted Date

Dec 3, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2015

Last Update Posted Date

Jan 9, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary objective of the study is to determine the safety of single doses of orally administered EDP-788.

Secondary objectives of the study are:

To describe the pharmacokinetics of EDP-788 (and its metabolite EDP-322) after single doses of orally administered drug
To estimate the bioavailability of EDP-788 capsules relative to an oral liquid suspension
To estimate the effect of co-administration of food on the absorption of EDP-788

Detailed Description

Subjects are enrolled in successive cohorts and are randomized to receive either EDP-788 or placebo capsules. If the safety profile of the drug is acceptable, based upon review of blinded data, the cohort receiving the next higher dose will be treated. Up to 8 cohorts will be recruited. All subjects receive a single dose of study drug (EDP-788 or placebo).

Subjects in Cohort C will receive a second single dose of study drug (EDP-788 or placebo) approximately 2 weeks after the first dose. The second dose will be administered as a liquid suspension rather than as a capsule formulation. The purpose of the second dose is to estimate the bioavailability of the capsule formulation relative to the suspension.

Subjects in Cohort E will receive a second single dose of study drug (EDP-788 or placebo) approximately 2 weeks after the first does. The second dose will be administered with a standard test meal. The purpose of the second dose is to estimate the effect of food on absorption of EDP-788.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EDP-788	Experimental	Single doses with dose escalation to continue in successive cohorts	Drug: EDP-788
Placebo	Placebo Comparator	Single dose with matching placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EDP-788	Drug	EDP-788 Capsules and matching placebo capsules. EDP-788 Liquid Suspension and matching placebo. All interventions are given as single doses	EDP-788

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence and severity of adverse events		From time of dosing to 8 - 10 days after receiving study drug

Secondary Outcomes

Measure	Description	Time Frame
Changes from baseline in laboratory values and vital signs		From time of dosing to 8 - 10 days after receiving study drug

Other Outcomes

Measure	Description	Time Frame
Pharmacokinetic parameters		From time of dosing to 3 days after receiving study drug

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

In good general health
BMI between 18 - 32 kg/m2
Women must be of non-childbearing potential (surgically sterilized)
Normal electrocardiogram
Willing to abstain from strenuous physical exercise starting 3 days prior to admission to the study clinic through the 8 - 10 day post-dosing visit

Key Exclusion Criteria:

Hypersensitivity to macrolide antibiotics
Abnormal laboratory values
History of gastrointestinal surgery which may interfere with drug absorption
Active Hepatitis B, Hepatitis C, or HIV infection
Use of prescription or non-prescription drugs within 14 days of study drug administration
Use of nicotine within 3 months of study drug administration

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Theresa T Pham, MD	PPD Phase I Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PPD Phase I Clinic		Austin	Texas	78744	United States