NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis Clinical Trial
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
Verified date | October 2021 |
Source | Enanta Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 82 |
Est. completion date | June 21, 2021 |
Est. primary completion date | June 21, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | PRA Health Sciences | Groningen |
Lead Sponsor | Collaborator |
---|---|
Enanta Pharmaceuticals | PRA Health Sciences |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety measured by adverse events | Up to 8 Days in SAD Cohorts | ||
Primary | Safety measured by adverse events | Up to 21 Days in MAD Cohorts | ||
Secondary | Cmax of EDP-297 | Up to 6 Days in SAD Cohorts | ||
Secondary | Cmax of EDP-297 | Up to 18 Days in MAD Cohorts | ||
Secondary | AUC of EDP-297 | Up to 6 Days in SAD Cohorts | ||
Secondary | AUC of EDP-297 | Up to 18 Days in MAD Cohorts |