Double Blind, Randomized, Placebo-controlled Study of Safety, Tolerability, and Pharmacokinetics of Ascending Doses of XC7 After Single and Multiple Oral Administration in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- XC7 100 mg single
- Conditions
- Covid19
- Sponsor
- NP Therapeutics
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Number of Adverse events (AEs) per treatment arm
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety, tolerability and pharmacokinetics (PK) of ascending doses of XC7 after single and multiple oral administration in healthy volunteers. It's planned to include sequentially 2 cohorts of 4 volunteers who will receive a single dose of XC7 (100 mg and 200 mg) or placebo (cohort ratio 3:1) and 1 cohort of 8 volunteers who will receive multiple doses of the XC7 (200 mg) or placebo during 14 days (cohort ratio 6:2).
Detailed Description
The study will be conducted in 1 centre. The study will consist of 3 periods: screening (7 days), treatment (1 or 14 days) and follow-up (7 or 28 days). The volunteers of single dosing cohorts will receive the investigated drug (ID) ХС7 or placebo once and stay at the study center for at least 24 hours after the ID administration to monitor the safety parameters and for sampling for PK analysis. The Follow-up will last 7 days, during which safety parameters and PK in volunteers will be studied. Based on all safety data from the XC7 100 mg cohort, the Data Safety Monitoring Committee (DSMC) will consider dose increase and entry of the 200 mg cohort. If the single dose of ХС7 200 mg is considered to be safe, the third multiple dosing cohort of 200 mg will be included in the study. The volunteers from multiple dosing cohort will receive the ID (ХС7 or placebo) once a day during 14 days and will stay at the hospital (study center) during the first five days after administration of the ID. The Follow-up will last 14 days, during which they will study safety parameters and PK in volunteers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Non-smoking men (nonsmokers at least within the last year before the screening) at the ages from 18 through 45;
- •Verified diagnosis "healthy" according to standard clinical, laboratory and instrumental methods of examination;
- •Body mass index from 18.5 to 30.0 kg/m2 with body weight of more than 45 kg and no more than 110 kg;
- •Negative result for alcohol vapor content in the exhaled air, narcotic substances in the urine;
- •Agreement to use adequate contraception methods during the study and 3 months after its completion: condoms with spermicide (foam, gel, cream, suppository);
- •Signed patient explanation sheet and informed consent for participation in the study.
Exclusion Criteria
- •Chronic diseases of the cardiovascular, bronchopulmonary, nervous, endocrine, musculoskeletal system, as well as the gastrointestinal tract, liver, kidneys, blood, mental illness, epilepsy or convulsive seizures;
- •Abnormal results of standard laboratory tests and investigations at the screening visit;
- •Gastrointestinal surgery (except for appendectomy) in the past medical history;
- •Systolic blood pressure of less than 90 mm Hg or above 139 mm Hg, diastolic blood pressure of less than 60 mm Hg or above 90 mm Hg, heart rate of less than 60 bpm or above 90 bpm - at screening;
- •Regular administration of drugs within 2 weeks prior to screening (including herbal agents and dietary supplements);
- •Use of drugs with significant effect on hemodynamics, hepatic function, etc. (e.g. barbiturates, omeprazole, cimetidine, etc.) within 30 days prior to screening;
- •Antibodies to HIV and hepatitis C, hepatitis B surface antigen, positive test for syphilis;
- •Unstable sleep architecture (e.g. night work, sleep disorders, insomnia, recently returned from another time zone, etc.), extreme physical activity (e.g. weight lifting);
- •Special diet (for example, vegetarian, vegan, low calorie (less than 1000 kcal/day));
- •Signs of alcohol abuse (intake of more than 10 units of alcohol per week) or 50 ml of hard alcohol; drinking alcohol within 4 days prior to screening;
Arms & Interventions
XC7 100 mg single
Cohort 1 - 4 subjects will be randomized in a 3:1 ratio to be treated either XC7 100 mg (3 subjects) or placebo (1 subject, see placebo single arm)
Intervention: XC7 100 mg single
XC7 200 mg single
Cohort 2 - 4 subjects will be randomized in a 3:1 ratio to be treated either XC7 200 mg (3 subjects) or placebo (1 subject, see placebo single arm)
Intervention: XC7 200 mg single
Placebo single
Placebo comparator arm will consist of 2 subjects (1 subject from Сohorts 1 and 2)
Intervention: Placebo single
XC7 200 mg multiple
Cohort 3 - 6 subjects will be randomized in a 6:2 ratio to be treated either XC7 200 mg (6 subjects) or placebo (1 subject, see placebo multiple arm)
Intervention: XC7 200 mg multiple
Placebo multiple
Placebo comparator arm will consist of 2 subjects from cohort 3
Intervention: Placebo multiple
Outcomes
Primary Outcomes
Number of Adverse events (AEs) per treatment arm
Time Frame: Day -7 (7 days before first dose) - Day 58
Adverse events will be classified according to CTCAE ver 4.03. Adverse events will be summarized descriptively by treatment arm. Verbatim terms will be mapped to preferred terms and organ systems using the current Medical Dictionary for Regulatory Activities version.
Secondary Outcomes
- Pharmacokinetics of XC7 by assessing AUC0-inf(Day 1 - Day 4)
- Pharmacokinetics of XC7 by assessing Tmax(Day 1 - Day 4)
- Pharmacokinetics of XC7 by assessing AUC0-t(Day 1 - Day 4)
- Pharmacokinetics of XC7 by assessing Cmax(Day 1 - Day 4)
- Pharmacokinetics of XC7 by assessing T1/2(Day 1 - Day 4)