Healthy Participants
Conditions
Brief summary
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WPV01 and WPV01 Co-administrated With Ritonavir in Healthy Adult Subjects.
Interventions
DRUGWPV01 Dose 1-4
WPV01 Dose 1-4 or Placebo on day 1
DRUGWPV01 Dose 5-8 and Ritonavir
WPV01 Dose 5-8 and Ritonavir or Placebo on day 1
DRUGWPV01 Dose 9-12
WPV01 Dose 9-12 or Placebo from day 1 to day 6
DRUGWPV01 Dose 13-15 and Ritonavir
WPV01 Dose 13-15 and Ritonavir or Placebo from day 1 to day 6
DRUGWPV01 Dose 16
Cohort 1:WPV01 Dose 16 or Placebo (with high fat meal) Cohort 2:WPV01 Dose 16 or Placebo (fasted)
Sponsors
Westlake Pharmaceuticals (Hangzhou) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects signed an informed consent form with full understanding of the test content, procedure and possible adverse effects * Chinese healthy male or female subjects between aged from 18 to 45 years * Subjects must agree to comply with the contraceptive requirements during the trial and for 3 months after the last dose * Body weight ≥ 50 kg for men and ≥ 45 kg for women and body mass index in the range of 18.0 \ 28.0 kg/m2 (including 18.0 and 28.0) * Subjects must be willing to understand and comply with study procedures and limitations, have the ability to complete the trial as planned, and be able to communicate effectively with the investigator
Exclusion criteria
* Participants who have special dietary requirements and cannot abide by the provided food * Pregnant or lactating women; Women who have pregnancy plan 1 month before trail, during trail or within 3 months after last dose; Women with positive serum pregnancy tests at screening or baseline * Participants who have evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic disease * Participants who have history of any other acute or chronic illness * Participants who have known allergy to any ingredient in the study treatment drug * Participants who are judged by the investigator to be unsuitable to participate in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety and tolerability of single and multiple oral doses of WPV01 and WPV01 in combination with ritonavir in healthy subjects. | Day 1 to Day 18 | Adverse events, including type, incidence, grade (determined with reference to NCI-CTCAE V5.0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time for Cmax (Tmax) in SAD | SAD part: Day 1 to Day 18 | Tmax was summarized by dosing regimen. It was observed directly from data as time of first occurrence. |
| Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) in SAD | SAD part: Day 1 to Day 18 | AUClast is summarized by dosing regimen and determined by linear/log trapezoidal method. |
| Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) in SAD | SAD part: Day 1 to Day 18 | AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). |
| Terminal Elimination Half-Life (t½) in SAD | SAD part: Day 1 to Day 18 | t1/2 is summarized by dosing regimen . It is determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline is used in the regression. |
| Apparent Clearance (CL/F) in SAD | SAD part: Day 1 to Day 18 | CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Calculated as Dose/AUCinf. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. |
| Apparent Volume of Distribution (Vz/F) in SAD | SAD part: Day 1 to Day 18 | Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed. |
| Maximum Plasma Concentration (Cmax) in Single Ascending Dose (SAD) | SAD part: Day 1 to Day 18 | The maximum observed plasma concentration (Cmax) is estimated based on the plasma concentrations |
| Time for Cmax (Tmax) in MAD | MAD part: Day 1 to Day 22 | Tmax was summarized by dosing regimen. It was observed directly from data as time of first occurrence. |
| Area Under the Plasma Concentration-Time Profile From Time Zero To End of Dosing Interval (AUCtau) in MAD | MAD part: Day 1 to Day 22 | AUCtau is summarized by dosing regimen and period. Dosing interval is the interval tau between administration of doses of drug. In this study, the dosing interval is 8 hours for three times daily (TID) dosing and 12 hours for twice daily (BID) dosing. It is determined by linear/log trapezoidal method. |
| To evaluate the metabolites of single oral doses of WPV01 and WPV01 in combination with ritonavir in healthy subjects | MAD part: Day 1 to Day 22 | Urine and stool samples will be collected for metabolite analysis. The major metabolites will be identified and, if necessary, quantitatively identified. |
| Cmax in Food Effect (FE) | Day 1 to Day 22 | The maximum observed plasma concentration (Cmax) is estimated based on the plasma concentrations of cohort 1 and cohort 2 in FE part. |
| Tmax in FE | Day 1 to Day 22 | It was observed directly from data as time of first occurrence in cohort 1 and cohort 2 of FE part. |
| Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) in FE | Day 1to Day 22 | AUClast was summarized using the data in cohort 1 and cohort 2 of FE part. |
| Cmax in Multiple Ascending Dose (MAD) | MAD part: Day 1 to Day 22 | Observed Cmax is estimated based on the plasma concentrations |
Countries
China
Outcome results
None listed