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A Study of EDP-297 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04559126
Recruitment Status : Recruiting
First Posted : September 22, 2020
Last Update Posted : September 22, 2020
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
Enanta Pharmaceuticals

Brief Summary:
This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-297 in healthy adult subjects.

Condition or disease Intervention/treatment Phase
NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis Drug: EDP-297 Drug: Placebo Phase 1

Detailed Description:

The first phase assesses single ascending doses of EDP-297 or placebo in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.

The second phase assesses multiple ascending doses of EDP-297 or placebo for 14-days in healthy subjects.

Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-297 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-297 or placebo

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study of Orally Administered EDP-297 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD), Multiple Ascending Doses (MAD), and the Effect of Food on EDP-297 Pharmacokinetics in Healthy Subjects
Actual Study Start Date : September 8, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EDP-297 SAD Cohorts
EDP-297 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 oral solution, once daily in one single administration
Drug: EDP-297
EDP-297 Oral solution

Experimental: EDP-297 MAD Cohorts
EDP-297 Dose 1, Dose 2 and Dose 3 oral solution, once daily for 14 days
Drug: EDP-297
EDP-297 Oral solution

Placebo Comparator: EDP-297 SAD Placebo Cohort
Matching placebo, oral solution, once daily in one single administration
Drug: Placebo
placebo to match EDP-297

Placebo Comparator: EDP-297 MAD Placebo Cohort
Matching placebo, oral solution, once daily for 14 days
Drug: Placebo
placebo to match EDP-297




Primary Outcome Measures :
  1. Safety measured by adverse events [ Time Frame: Up to 8 Days in SAD Cohorts ]
  2. Safety measured by adverse events [ Time Frame: Up to 21 Days in MAD Cohorts ]

Secondary Outcome Measures :
  1. Cmax of EDP-297 [ Time Frame: Up to 6 Days in SAD Cohorts ]
  2. Cmax of EDP-297 [ Time Frame: Up to 18 Days in MAD Cohorts ]
  3. AUC of EDP-297 [ Time Frame: Up to 6 Days in SAD Cohorts ]
  4. AUC of EDP-297 [ Time Frame: Up to 18 Days in MAD Cohorts ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • An informed consent document signed and dated by the subject.
  • Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive.

Exclusion Criteria:

  • Clinically relevant evidence or history of illness or disease.
  • Pregnant or nursing females.
  • History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
  • A positive urine drug screen at screening or Day -2.
  • Current tobacco smokers or use of tobacco within 1 months prior to screening.
  • Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
  • History of regular alcohol consumption exceeding 14 drinks/week for females and 21 drinks/week for males within 6 months of Screening.
  • Participation in a clinical trial within 30 days prior to the first dose of study drug.

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): NCT04559126


Contacts
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Contact: Enanta Pharmaceuticals, Inc 6176070705 nadda@enanta.com

Locations
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Netherlands
PRA Health Sciences Recruiting
Groningen, Netherlands, 9728 NZ
Principal Investigator: S.P. van Marle         
Sponsors and Collaborators
Enanta Pharmaceuticals
PRA Health Sciences
Investigators
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Study Director: Enanta Pharmaceuticals, Inc Enanta Pharmaceuticals, Inc
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Responsible Party: Enanta Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04559126    
Other Study ID Numbers: EDP 297-001
First Posted: September 22, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Enanta Pharmaceuticals:
"First-in-Human"
Single Ascending Dose
Multiple Ascending Dose
Healthy Volunteer
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Cirrhosis
Liver Diseases
Digestive System Diseases