ICON Early Phase
San Antonio, Texas, 78209, United States
Location status: Recruiting
Location contact
Cassandra Key, MD
PRINCIPAL_INVESTIGATOR
Shannon
CONTACT
Shannon Kirk
CONTACT
NCT Number: NCT07540910
This study is a randomized, double-blind, sponsor-open, placebo-controlled study. It will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered single and multiple doses of EDP-978 in healthy adult subjects.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 1
San Antonio, Texas, 78209, United States
Location status: Recruiting
Cassandra Key, MD
PRINCIPAL_INVESTIGATOR
Shannon
CONTACT
Shannon Kirk
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral administration
Placebo to match EDP-978, oral administration
Time frame: Up to 8 Days in SAD Cohorts
Time frame: Up to 28 Days in MAD Cohorts
Time frame: Up to 5 Days in SAD Cohorts
Time frame: Up to 5 Days in SAD Cohorts
Time frame: Up to 18 Days in MAD Cohorts
Time frame: Up to 18 Days in MAD Cohorts
Time frame: Up to 12 Days in FE SAD Cohort
Food effects on plasma PK parameters of EDP-978
Time frame: Up to 12 Days in FE SAD Cohort
Food effects on plasma PK parameters of EDP-978
Contact information is provided by the study sponsor or research team.
Enanta Pharmaceuticals, Inc
Industry
A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, First-In-Human, Phase 1 Study of Orally Administered EDP-978 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses, Multiple Ascending Doses, and the Effect of Food on EDP-978 Pharmacokinetics in Healthy Adult Participants
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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