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

NCT ID: NCT04632706

Last Updated: 2021-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-22
• Study Completion Date: 2021-03-09

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

50mcg/kg (oral)

Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28

Group Type: EXPERIMENTAL

Ivermectin

Intervention Type: DRUG

Ivermectin: Investigation of the safety, tolerability and the pharmacokinetic profile of the active IMP in an exploratory study

75mcg/kg (oral)

Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28

Group Type: EXPERIMENTAL

Ivermectin

Intervention Type: DRUG

Ivermectin: Investigation of the safety, tolerability and the pharmacokinetic profile of the active IMP in an exploratory study

100mcg/kg (oral)

Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28

Group Type: EXPERIMENTAL

Ivermectin

Intervention Type: DRUG

Ivermectin: Investigation of the safety, tolerability and the pharmacokinetic profile of the active IMP in an exploratory study

Matching Placebo (oral)

Placebo using tablets identical to the Active IMP

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo to the Active IMP.

Interventions

Ivermectin

Ivermectin: Investigation of the safety, tolerability and the pharmacokinetic profile of the active IMP in an exploratory study

Intervention Type: DRUG

Placebo

Matching Placebo to the Active IMP.

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

MedinCell S.A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pui Man Leung, MD

Role: PRINCIPAL_INVESTIGATOR

MAC Clinical Research

Locations

MAC Clinical Research Manchester (Early Phase Unit), Neuroscience Centre of Excellence

Manchester, Greater Mancherster, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

mdc-TTG-CT-001

Identifier Type: -

Identifier Source: org_study_id