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A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WPV01 and WPV01 Co-administrated With Ritonavir in Healthy Adult Subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WPV01 Dose 1-4 | Experimental | WPV01 Dose 1-4 or Placebo |
|
| WPV01 Dose 5-8 | Experimental | WPV01 Dose 5-8 co-administrated with ritonavir or Placebo |
|
| WPV01 Dose 9-12 | Experimental | WPV01 Dose 9-12 or Placebo |
|
| WPV01 Dose 13-15 | Experimental | WPV01 Dose 13-15 or Placebo |
|
| WPV01 Dose 16 | Experimental | WPV01 Dose 16(with high fat meal) or WPV01 Dose 16 (fed) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WPV01 Dose 1-4 | Drug | WPV01 Dose 1-4 or Placebo on day 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of single and multiple oral doses of WPV01 and WPV01 in combination with ritonavir in healthy subjects. | Adverse events, including type, incidence, grade (determined with reference to NCI-CTCAE V5.0) | Day 1 to Day 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) in Single Ascending Dose (SAD) | The maximum observed plasma concentration (Cmax) is estimated based on the plasma concentrations | SAD part: Day 1 to Day 18 |
| Time for Cmax (Tmax) in SAD |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shulan(Hangzhou) Hospital | Hangzhou | China |
6 months after summary data has been published, sponsor will share the IPD and additional supporting information after internal approval process.
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| ID | Term |
|---|---|
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| WPV01 Dose 5-8 and Ritonavir |
| Drug |
WPV01 Dose 5-8 and Ritonavir or Placebo on day 1 |
|
| WPV01 Dose 9-12 | Drug | WPV01 Dose 9-12 or Placebo from day 1 to day 6 |
|
| WPV01 Dose 13-15 and Ritonavir | Drug | WPV01 Dose 13-15 and Ritonavir or Placebo from day 1 to day 6 |
|
| WPV01 Dose 16 | Drug | Cohort 1:WPV01 Dose 16 or Placebo (with high fat meal) Cohort 2:WPV01 Dose 16 or Placebo (fasted) |
|
Tmax was summarized by dosing regimen. It was observed directly from data as time of first occurrence.
| SAD part: Day 1 to Day 18 |
| Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) in SAD | AUClast is summarized by dosing regimen and determined by linear/log trapezoidal method. | SAD part: Day 1 to Day 18 |
| Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) in SAD | 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). | SAD part: Day 1 to Day 18 |
| Terminal Elimination Half-Life (t½) in SAD | 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. | SAD part: Day 1 to Day 18 |
| Apparent Clearance (CL/F) in SAD | 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. | SAD part: Day 1 to Day 18 |
| Apparent Volume of Distribution (Vz/F) in SAD | 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. | SAD part: Day 1 to Day 18 |
| Cmax in Multiple Ascending Dose (MAD) | Observed Cmax is estimated based on the plasma concentrations | MAD part: Day 1 to Day 22 |
| Time for Cmax (Tmax) in MAD | Tmax was summarized by dosing regimen. It was observed directly from data as time of first occurrence. | MAD part: Day 1 to Day 22 |
| Area Under the Plasma Concentration-Time Profile From Time Zero To End of Dosing Interval (AUCtau) in MAD | 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. | MAD part: Day 1 to Day 22 |
| To evaluate the metabolites of single oral doses of WPV01 and WPV01 in combination with ritonavir in healthy subjects | Urine and stool samples will be collected for metabolite analysis. The major metabolites will be identified and, if necessary, quantitatively identified. | MAD part: Day 1 to Day 22 |
| Cmax in Food Effect (FE) | The maximum observed plasma concentration (Cmax) is estimated based on the plasma concentrations of cohort 1 and cohort 2 in FE part. | Day 1 to Day 22 |
| Tmax in FE | It was observed directly from data as time of first occurrence in cohort 1 and cohort 2 of FE part. | Day 1 to Day 22 |
| Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) in FE | AUClast was summarized using the data in cohort 1 and cohort 2 of FE part. | Day 1to Day 22 |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |