Safety and Pharmacokinetics of Y-4 Tablets in Healthy Subjects
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorBeijing Tiantan Hospital
About this trial
Y-4 is a new fixed-dose combination drug product containing two active ingredients of pregabalin and riluzole.
The primary objective is to evaluate the safety and tolerability of Y-4 tablets in Chinese healthy adult subjects after single- and multiple-dose.
The secondary objective is to characterize the pharmacokinetics (PK) of pregabalin and riluzole in Chinese healthy adult subjects after single- and multiple-dose of Y-4 tablets.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adult male and female subjects, 18-45 years of age (including both ends).
Body weight ≥ 50 kg for male and ≥ 45 kg for female, body mass index (BMI) within the range of 19 - 28 kg/m2 (including both ends).
During the screening period, serum creatinine is within the normal range, or the standard creatinine clearance (CLcr) estimated by Cockcroft-Gault formula is ≥ 80 mL/min (for female subject, according to the calculation result × 0.85）.
Subjects who are able to understand and give their signed informed consent before any trial related procedures are performed.
Disqualifiers
Subjects who are known to be allergic to pregabalin, riluzole or any excipients of Y-4 tablets (microcrystalline cellulose, Copovidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate and Opadry amb Ⅱ), have allergic diseases or allergic constitution;
Subjects who have special requirements for diet and cannot follow the unified diet;
Physical examinations, vital signs, 12-lead electrocardiograms (ECG), chest X-ray (front position), laboratory tests (hematology, serum chemistry, coagulation test, urinalysis, etc.) and other screening tests found abnormalities that the researchers judged to be of clinical significance;
Subjects who have experienced angioedema in the past (such as swelling of the face, mouth (tongue, lips, and gums), and neck (pharynx and throat));
Trial design
Design model
Parallel
Treatments tested in this trial
Y-4 tables
DrugEach subject will receive a single dose and multiple doses. During the single dose phase (Day1-Day4), the subjects will be administered with single dose of Y-4 tablets on fasting state in the morning of Day D1. During the multiple dosing phase (Day5-Day13), the subjects will be required to administer with Y-4 tablets continuously for 6 days, BID of Day5-Day9 (once in the morning and once in the evening, Q12h) and QD of Day10, for a total of 11 doses.
Y-4 placebos
DrugEach subject will receive a single dose and multiple doses. During the single dose phase (Day1-Day4), the subjects will be administered with single dose of Y-4 placebos on fasting state in the morning of Day D1. During the multiple dosing phase (Day5-Day13), the subjects will be required to administer with Y-4 placebos continuously for 6 days, BID of Day5-Day9 (once in the morning and once in the evening, Q12h) and QD of Day10, for a total of 11 doses.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Y-4 tablesExperimental treatment 1 intervention
Group B: Y-4 placebosPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
adverse events
An AE is defined as any untoward medical event that occurs after receiving a drug or treatment or any deterioration of a disease or symptom that existed before receiving the investigational product or treatment (excluding the disease studied in this trial) in a subject or a clinical investigation subject, whether or not considered related to the investigational product or treatment. Therefore, an AE can be a discomfort sign (including an abnormal laboratory finding), symptom, or transient disease beyond any indication, whether or not related to the investigational product or treatment. The investigator will name each AE reported during the study by MedDRA PT and evaluate their severity using the criteria of "mild", "moderate" and "severe". The relevance evaluation is divided into 5 grades: 1-certainly related; 2- probably/likely related; 3-possibly related; 4-unlikely related; 5 not related.
Time frame
From the first day to the 19th± 1st day after the start of administration2
Incidence of subject getting abnormal results of laboratory tests after treatment
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Laboratory tests are composed of hematology, urinalysis, serum chemistry, coagulation test. Normal range is provided by the site.
Time frame
From the first day to the 19th± 1st day after the start of administration3
Incidence of subject getting abnormal results of 12-lead ECG after treatment
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. 12-lead ECG will be analyzed by single RR Heart Rate, aggregate PR Interval, aggregate QRS Duration, aggregate RR Interval, aggregate QT Interval, aggregate QTC Interval. Normal range is provided by the site.
Time frame
From the first day to the 19th± 1st day after the start of administration4
Incidence of subject getting abnormal results of vital signs after treatment.
Record changes from baseline to post-treatment, listing deviations from normal ranges post-treatment. Vital signs(body temperature, respiration, blood pressure, and pulse) will be assessed by according equipment.(electronic sphygmomanometer, thermometer).
Time frame
From the first day to the 19th± 1st day after the start of administrationSecondary outcomes
1
Cmax
peak plasma concentration after single dose
Time frame
From day 1 to day 4 after the start of administration2
AUC0-t
Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration after single dose
Time frame
From day 1 to day 4 after the start of administration3
AUC0-∞
Area under the plasma concentration-time curve from time 0 to infinity (extrapolated) after single dose
Time frame
From day 1 to day 4 after the start of administration4
Tmax
Time to reach maximum observed plasma concentration after single dose
Time frame
From day 1 to day 4 after the start of administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Tiantan Hospital
Lead sponsor
Neurodawn Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov