Clinical trial NCT04632706: Exploratory Ph I Trial of the Active IMP in Healthy Volunteers in Relation to COVID-19
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Covid19
Lead sponsor: MedinCell S.A
Sponsor class: INDUSTRY
First posted: 2020-11-17
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pharmacokinetic Concentrations - (Maximum Plasma Concentration [Cmax])
timeFrame: D1, D2 and D28
measure: Pharmacokinetic Concentrations - (Time to Reach Cmax [Tmax])
timeFrame: D1, D2 and D28
measure: Pharmacokinetic Concentrations - (Area Under the Plasma Concentration-time Curve From Zero to 24 Hours [AUC0-24hr])
timeFrame: D1, D2 and D28
measure: Pharmacokinetic Concentrations - (Apparent Terminal Half-Life [T1/2])
timeFrame: D28
Secondary outcomes:
measure: Safety and Tolerability - Treatment Emergent Adverse Events (TEAEs)
timeFrame: From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days.
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: MAC Clinical Research Manchester (Early Phase Unit), Neuroscience Centre of Excellence
state: Greater Mancherster
Study officials:
affiliation: MAC Clinical Research
name: Pui Man Leung, MD
role: PRINCIPAL_INVESTIGATOR
References: