- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04392219
COVID-19 First In Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of EIDD-2801 in Healthy Volunteers
A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Study Designed to Evaluate the Safety, Tolerability, and Pharmacokinetics of EIDD-2801 Following Oral Administration to Healthy Volunteers
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Leeds, United Kingdom
- Covance Leeds Clinical Research Unit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female between the ages of 18 and 60, inclusive.
- Female participants must be of non-childbearing potential.
- Male participants must agree to the use of effective contraception for study duration
- Is in generally good health as determined by medical history, physical examinations (PEs) (at Screening and/or Check-in), vital signs, and other screening procedures.
- Has a body mass index (BMI) of 18 to 30 kg/m^2.
Exclusion Criteria:
- Females who are pregnant, planning to become pregnant, or breastfeeding.
- Has a clinically relevant acute or chronic medical condition or disease of the cardiovascular, gastrointestinal (GI), hepatic, renal, endocrine, pulmonary, neurologic, or dermatologic systems as determined by the principal investigator (PI) (or designee).
- Has any current or historical disease or disorder of the hematological system or significant liver disease or family history of bleeding/platelet disorders.
- Has a history of cancer (other than basal cell or squamous cell cancer of the skin), rheumatologic disease or blood dyscrasias.
- Has a history of gastrointestinal (GI) surgery or other condition that may interfere with absorption of study drug, in the opinion of the principal investigator (PI) (or designee).
- Has a history of febrile illness within the 14 days prior to the first dose of study drug.
- Has a positive alcohol or drug screen at Screening or the Day -1 visit or has a history of alcohol or drug abuse within the past 5 years.
- Currently uses tobacco, nicotine or tobacco products or e-cigarettes, or stopped using tobacco products within the past 3 months
- Has a total white cell count or absolute lymphocyte count outside the normal range, or hemoglobin or platelet levels below the lower limit of normal, at Screening or Day -1.
- Has values above the upper limit of normal for the following laboratory analytes: alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT), alkaline phosphatase (serum), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), at Screening or Day -1.
- Positive test result for human immunodeficiency virus (HIV), hepatitis b virus (HBV), or hepatitis c virus (HCV).
- Has an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
Has any of the following:
- QT interval corrected for heart rate (using Fridericia's formula) (QTcF) >450 ms confirmed by repeat measurement
- QRS duration >110 ms confirmed by repeat measurement
- PR interval >220 ms confirmed by repeat measurements
- findings which would make QTc measurements difficult or QTc data uninterpretable
- history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).
- Except as noted, has used prescription drugs (other than hormone replacement therapy) within 14 days prior to the first dose of study drug unless, in the opinion of the PI (or designee), the drug will not interfere with study assessments.
- Has received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 3 months prior to the first dose of study drug and agrees not to receive another experimental agent during the duration of this trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EIDD-2801
EIDD-2801: Part 1: Participants were randomized to receive 50 to 1600 mg EIDD-2801 powder-in bottle (fasted); Part 2: Participants were randomized to receive two single 200 mg doses (fed or fasted); Part 3: Participants were randomized to receive twice daily doses of EIDD-2801 in an open-label manner.
|
Part 1: Participants will be randomized to receive a single oral dose of EIDD-2801 or Placebo. Part 2: Two single oral doses of EIDD-2801 will be administered to participants, in an open-label manner. Part 3: Participants will be randomized to receive twice daily dosing either EIDD-2801 or Placebo.
Other Names:
|
Placebo Comparator: Placebo
Placebo: Part 1: Participants were randomized to receive placebo (fasted); Part 3: Participants were randomized to receive placebo (fasted).
|
Part 1: Participants will be randomized to receive a single oral dose of EIDD-2801 or Placebo. Part 3: Participants will be randomized to receive twice daily dosing either EIDD-2801 or Placebo. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 1: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events
Time Frame: From screening through study completion, up to 15 days
|
Number of participants with treatment emergent adverse events (TEAEs) and severity of TEAEs following a single dose of EIDD-2801 in Part 1
|
From screening through study completion, up to 15 days
|
Part 3: Number of Participants With Treatment Emergent Adverse Events and Severity of Treatment Emergent Adverse Events
Time Frame: From screening through study completion, up to 20 days
|
Number of participants with treatment emergent adverse events (TEAEs) and severity of TEAEs following multiple doses of EIDD-2801 in Part 3
|
From screening through study completion, up to 20 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jim Bush, MBChB, PhD, Covance Clinical Research Unit Limited
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EIDD-2801-1001
- 2020-001407-17 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronavirus
-
Salvacion USA Inc.Completed
-
Janssen Vaccines & Prevention B.V.Completed
-
Texas A&M UniversityM.D. Anderson Cancer Center; Baylor College of Medicine; Cedars-Sinai Medical... and other collaboratorsActive, not recruitingCoronavirus Infection | Coronavirus | Coronavirus as the Cause of Diseases Classified ElsewhereUnited States
-
Beijing Ditan HospitalUnknown
-
Qilu Hospital of Shandong UniversityRecruitingCoronavirus | Traditional Chinese MedicineChina
-
Maimonides Medical CenterTerminatedCOVID, CoronavirusUnited States
-
Materno-Perinatal Hospital of the State of MexicoLaboratorios LiomontCompletedCoronavirus InfectionMexico
-
Bursa Yüksek İhtisas Education and Research HospitalUnknownCoronavirus as the Cause of Diseases Classified ElsewhereTurkey
-
TakedaWithdrawn
-
OSF Healthcare SystemTerminatedCOVID-19 | Coronavirus Infection | COVID | Corona Virus Infection | Coronavirus | Sars-CoV2 | SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere | Coronavirus Disease | Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere | Coronavirus as the Cause of Diseases Classified...United States
Clinical Trials on EIDD-2801
-
Merck Sharp & Dohme LLCCompletedHepatic ImpairmentUnited States
-
Merck Sharp & Dohme LLCCompletedRenal ImpairmentUnited States
-
Ridgeback Biotherapeutics, LPMerck Sharp & Dohme LLCCompletedSARS-CoV 2United States
-
University of LiverpoolUniversity of Southampton; Liverpool University Hospitals NHS Foundation Trust and other collaboratorsActive, not recruiting