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Exploratory Ph I Trial of the Active IMP in Healthy Volunteers in Relation to COVID-19

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04632706
Recruitment Status : Completed
First Posted : November 17, 2020
Results First Posted : December 27, 2021
Last Update Posted : December 27, 2021
Sponsor:
Information provided by (Responsible Party):
MedinCell S.A

Tracking Information
First Submitted Date  ICMJE October 26, 2020
First Posted Date  ICMJE November 17, 2020
Results First Submitted Date  ICMJE December 14, 2021
Results First Posted Date  ICMJE December 27, 2021
Last Update Posted Date December 27, 2021
Actual Study Start Date  ICMJE September 22, 2020
Actual Primary Completion Date March 9, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2021)
  • Pharmacokinetic Concentrations - (Maximum Plasma Concentration [Cmax]) [ Time Frame: D1, D2 and D28 ]
    Maximum plasma concentration (Cmax)
  • Pharmacokinetic Concentrations - (Time to Reach Cmax [Tmax]) [ Time Frame: D1, D2 and D28 ]
    Time to reach Cmax (Tmax)
  • Pharmacokinetic Concentrations - (Area Under the Plasma Concentration-time Curve From Zero to 24 Hours [AUC0-24hr]) [ Time Frame: D1, D2 and D28 ]
    area under the plasma concentration-time curve from zero to 24 hours (AUC0-24hr) concentration-time curve from zero to 24 hours (AUC0-24hr)
  • Pharmacokinetic Concentrations - (Apparent Terminal Half-Life [T1/2]) [ Time Frame: D28 ]
    apparent terminal half-life (t1/2)
Original Primary Outcome Measures  ICMJE
 (submitted: November 16, 2020)
  • Pharmacokinetic concentrations - (Maximum Plasma Concentration [Cmax]) [ Time Frame: Study day 42 (at 14 days post the final dose) ]
    Maximum plasma concentration (Cmax)
  • Pharmacokinetic concentrations - (Time to Reach Cmax [Tmax]) [ Time Frame: Study day 42 (at 14 days post the final dose) ]
    Time to reach Cmax (tmax)
  • Pharmacokinetic concentrations - (Trough Plasma Concentration [Ctrough]) [ Time Frame: Study day 42 (at 14 days post the final dose) ]
    trough plasma concentration (Ctrough)
  • Pharmacokinetic concentrations - (Area under the plasma concentration-time curve from zero to 24 hours [AUC0-24h]) [ Time Frame: Study day 42 (at 14 days post the final dose) ]
    area under the plasma concentration-time curve from zero to 24 hours (AUC0-24h) concentration-time curve from zero to 24 hours (AUC0-24h)
  • Pharmacokinetic concentrations - (Area under the plasma concentration-time curve from zero to 48 hours [AUC0-48h]) [ Time Frame: Study day 42 (at 14 days post the final dose) ]
    area under the plasma concentration-time curve from zero to 48 hours (AUC0-48h)
  • Pharmacokinetic concentrations - (Average Plasma Concentration at steady state [Cavg ss]) [ Time Frame: Study day 42 (at 14 days post the final dose) ]
    average plasma concentration at steady state (Cavg ss)
  • Pharmacokinetic concentrations - (Apparent Terminal Half-Life [T1/2]) [ Time Frame: Study day 42 (at 14 days post the final dose) ]
    apparent terminal half-life (t1/2)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2021)
Safety and Tolerability - Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days. ]
Clinical safety data from adverse event (AE) reporting
Original Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2020)
  • Safety and Tolerability - Number of participants with treatment emergent adverse events (TEAEs) [ Time Frame: Study day 42 (at 14 days post the final dose) ]
    Clinical safety data from adverse event (AE) reporting
  • Safety and Tolerability - Number of participants with abnormal electrocardiograms (ECG) [ Time Frame: Study day 42 (at 14 days post the final dose) ]
    Assessment of cardiac electrical activity
  • Safety and Tolerability - Number of participants with abnormal clinical neurological exam, as assessed by the investigator [ Time Frame: Study day 42 (at 14 days post the final dose) ]
    Assessment of neurological function
  • Safety and Tolerability - Number of participants with abnormal urine and/or blood test, as compared to reference laboratory values [ Time Frame: Study day 42 (at 14 days post the final dose) ]
    Assessment of clinical laboratory results
  • Safety and Tolerability - Number of participants with abnormal physical exams, as assessed by the investigator [ Time Frame: Study day 42 (at 14 days post the final dose) ]
    Assessment of physical examination results
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploratory Ph I Trial of the Active IMP in Healthy Volunteers in Relation to COVID-19
Official Title  ICMJE A Randomised, Double-Blind, Placebo-Controlled, Exploratory Phase I Trial Assessing the Pharmacokinetic Profile, Safety and Tolerability of a Continuous Daily Dosing Regimen of Active IMP in Healthy Volunteers
Brief Summary An early stage trial to check how safe and tolerable, as well as how the body handles continuous daily use of Active IMP over 28 days in healthy volunteers.
Detailed Description Detailed information restricted because this is a Phase 1 clinical trial.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
The study is a placebo-controlled, double-blinded exploratory study to investigate safety, Pk and tolerability of a continuous daily dosing of the active drugs (at 3 different doses) in healthy participants.
Masking: Double (Participant, Investigator)
Masking Description:
The study is double-blinded. Patients will be randomised to receive 1 of 3 doses of the Active IMP or a matching placebo.
Primary Purpose: Other
Condition  ICMJE Covid19
Intervention  ICMJE
  • Drug: Ivermectin
    Ivermectin: Investigation of the safety, tolerability and the pharmacokinetic profile of the active IMP in an exploratory study
  • Drug: Placebo
    Matching Placebo to the Active IMP.
Study Arms  ICMJE
  • Experimental: 50mcg/kg (oral)
    Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28
    Intervention: Drug: Ivermectin
  • Experimental: 75mcg/kg (oral)
    Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28
    Intervention: Drug: Ivermectin
  • Experimental: 100mcg/kg (oral)
    Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28
    Intervention: Drug: Ivermectin
  • Placebo Comparator: Matching Placebo (oral)
    Placebo using tablets identical to the Active IMP
    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: November 16, 2020)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 9, 2021
Actual Primary Completion Date March 9, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Important Inclusion Criteria:

  • Subject is male of any ethnic origin.
  • Subject is aged between 18 to 45 years, inclusive.
  • Subject has a body mass index (BMI) of 18.5 to 32.0 kg/m2, inclusive.
  • Subject is ≥50 kg.
  • Negative reverse transcription polymerase chain reaction (RT-PCR) Test for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) at Screening and negative lateral flow immunoassay test for SARS-CoV-2 at Day -1.
  • Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examinations, neurological examinations, concomitant medication, vital signs, 12-lead ECG and clinical laboratory evaluations.
  • Male subjects must use a condom during the study and for 3 months after their final dose of study medication, if their partner is a woman of childbearing potential. In addition, their female partner of childbearing potential must use an additional method of highly effective contraception from first dosing until 3 months following final dosing.

Important Exclusion Criteria:

  • Clinically relevant history of abnormal physical or mental health (defined as any subject requiring medical, psychological or pharmacotherapeutic intervention for mental illness) interfering with the study as determined by medical history and physical examinations obtained during Screening and Day -1 as judged by the Investigator (including [but not limited to], neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder).
  • Any other concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study as outlined in this Protocol, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.
  • Evidence of previous SARS-CoV-2 infection from medical history.
  • Ophthalmologic disorder (moderate and sever retina or optic nerve pathology; cataracts excluded).
  • Subjects with a diagnosis of asthma or any other respiratory conditions.
  • A neurologic disorder that may compromise blood brain barrier permeability (stroke within 90 days, brain tumour, multiple sclerosis, or other neuroinflammatory condition, a neurodegenerative disorder, epilepsy) or history of seizures.
  • Positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibody (anti-HCV) or human immunodeficiency virus I and II (anti-HIV I/II) at Screening.
  • The subject has participated in a clinical study and has received a medication or a new chemical entity within 3 months or 5 half-lives (whichever is longer) prior to first dosing of current study medication.
  • Use of any drugs that are known substrates of CYP3A4, P-glycoprotein (P-gp) from within 4 weeks of Screening and unable to refrain from them until the end of the study (e.g., rifampicin, quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat). Use of critical CYP3A4 substrate drugs such as warfarin or coumarin anticoagulants.
  • Recent or expected microfilaricidal drug use, including ivermectin, or travel history to areas that are endemic for Loa loa or onchocerciasis (Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan).
  • Use of medications having potential activity against SARS-CoV-2 such as hydroxychloroquine, chloroquine, lopinavir, ritonavir, remdesivir, azithromycin, in the 30 days prior to Screening and unable to refrain from them until the end of the study.
  • Consumption of any food or drinks containing cranberry, pomegranate, starfruit, grapefruit, pomelos, exotic citrus fruits or Seville oranges (including marmalade and juices made from these fruits) within 14 days prior to first dosing until the end of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 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  
 
Administrative Information
NCT Number  ICMJE NCT04632706
Other Study ID Numbers  ICMJE mdc-TTG-CT-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party MedinCell S.A
Original Responsible Party Same as current
Current Study Sponsor  ICMJE MedinCell S.A
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pui Man Leung, MD MAC Clinical Research
PRS Account MedinCell S.A
Verification Date December 2021

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