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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04632706
• Other study ID #: mdc-TTG-CT-001
• Status: Completed
• Phase: Phase 1
• Start date: September 22, 2020
• Est. completion date: March 9, 2021

Study information

• Verified date: December 2021
• Source: MedinCell S.A
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Detailed information restricted because this is a Phase 1 clinical trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 9, 2021
• Est. primary completion date: March 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Ivermectin
Ivermectin: Investigation of the safety, tolerability and the pharmacokinetic profile of the active IMP in an exploratory study
• Placebo
Matching Placebo to the Active IMP.

Locations

Country	Name	City	State
United Kingdom	MAC Clinical Research Manchester (Early Phase Unit), Neuroscience Centre of Excellence	Manchester	Greater Mancherster

Sponsors (1)

Lead Sponsor	Collaborator
MedinCell S.A

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic Concentrations - (Maximum Plasma Concentration [Cmax])	Maximum plasma concentration (Cmax)	D1, D2 and D28
Primary	Pharmacokinetic Concentrations - (Time to Reach Cmax [Tmax])	Time to reach Cmax (Tmax)	D1, D2 and D28
Primary	Pharmacokinetic Concentrations - (Area Under the Plasma Concentration-time Curve From Zero to 24 Hours [AUC0-24hr])	area under the plasma concentration-time curve from zero to 24 hours (AUC0-24hr) concentration-time curve from zero to 24 hours (AUC0-24hr)	D1, D2 and D28
Primary	Pharmacokinetic Concentrations - (Apparent Terminal Half-Life [T1/2])	apparent terminal half-life (t1/2)	D28
Secondary	Safety and Tolerability - Treatment Emergent Adverse Events (TEAEs)	Clinical safety data from adverse event (AE) reporting	From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days.