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COVID-19 First In Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of EIDD-2801 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT04392219
Recruitment Status : Completed
First Posted : May 18, 2020
Results First Posted : July 19, 2021
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
Ridgeback Biotherapeutics, LP

Tracking Information
First Submitted Date  ICMJE April 29, 2020
First Posted Date  ICMJE May 18, 2020
Results First Submitted Date  ICMJE June 15, 2021
Results First Posted Date  ICMJE July 19, 2021
Last Update Posted Date July 19, 2021
Actual Study Start Date  ICMJE April 10, 2020
Actual Primary Completion Date August 11, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2021)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2020)
  • Safety and Tolerability of Single Ascending Dose (SAD) of EIDD-2801 (Part 1): Adverse Events [ Time Frame: From screening through study completion, up to 15 days ]
    Number and severity of treatment emergent adverse events
  • Safety and Tolerability of Multiple Ascending Dose (MAD) of EIDD-2801 (Part 3): Adverse Events [ Time Frame: From screening through study completion, up to 20 days ]
    Number and severity of treatment emergent adverse events
  • Pharmacokinetics (PK) of EIDD-2801 when given as Single Doses (Part 2): Maximum observed concentration Cmax [ Time Frame: Day 1 through Day 18 ]
    Multiple pharmacokinetic variables of EIDD-2801 will be assessed and may include, but are not limited to: Maximum observed concentration Cmax
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2020)
  • Pharmacokinetics (PK) of EIDD-2801 when given as Single Ascending Dose (SAD) (Part 1): Maximum observed concentration Cmax [ Time Frame: Day 1 up to Day 4 ]
    Multiple PK variables of EIDD-2801 will be assessed and may include, but are not limited to: Maximum observed concentration Cmax
  • Pharmacokinetics (PK) of EIDD-2801 when given as Multiple Ascending Dose (MAD) (Part 3): Maximum observed concentration Cmax [ Time Frame: Day 1 up to Day 14 ]
    Multiple PK variables of EIDD-2801 will be assessed and may include, but are not limited to: Maximum observed concentration Cmax
  • Safety and Tolerability of Single Doses of EIDD-2801 (Part 2): Adverse Events [ Time Frame: From screening through study completion, up to 30 days ]
    Number and severity of treatment emergent adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE COVID-19 First In Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of EIDD-2801 in Healthy Volunteers
Official Title  ICMJE 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
Brief Summary This is a First In Human study designed to assess the safety, tolerability and pharmacokinetics of EIDD-2801 in healthy human volunteers.
Detailed Description This is 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Coronavirus
Intervention  ICMJE
  • Drug: EIDD-2801

    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 Name: Molnupiravir
  • Drug: Placebo

    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.

Study Arms  ICMJE
  • 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.
    Intervention: Drug: EIDD-2801
  • Placebo Comparator: Placebo
    Placebo: Part 1: Participants were randomized to receive placebo (fasted); Part 3: Participants were randomized to receive placebo (fasted).
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2020)
130
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2020)
122
Actual Study Completion Date  ICMJE August 11, 2020
Actual Primary Completion Date August 11, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT04392219
Other Study ID Numbers  ICMJE EIDD-2801-1001
2020-001407-17 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ridgeback Biotherapeutics, LP
Study Sponsor  ICMJE Ridgeback Biotherapeutics, LP
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jim Bush, MBChB, PhD Covance Clinical Research Unit Limited
PRS Account Ridgeback Biotherapeutics, LP
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP