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Completed

NCT Number: NCT06205329

Study of WPV01 in Healthy Subjects

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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Key information

Conditions

Healthy Participants

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shulan(Hangzhou) Hospital

Hangzhou, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WPV01 Dose 1-4

Drug

WPV01 Dose 1-4 or Placebo on day 1

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)

Primary outcomes

  1. To evaluate the safety and tolerability of single and multiple oral doses of WPV01 and WPV01 in combination with ritonavir in healthy subjects.

    Time frame: Day 1 to Day 18

    Adverse events, including type, incidence, grade (determined with reference to NCI-CTCAE V5.0)

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax) in Single Ascending Dose (SAD)

    Time frame: SAD part: Day 1 to Day 18

    The maximum observed plasma concentration (Cmax) is estimated based on the plasma concentrations

  2. Time for Cmax (Tmax) in SAD

    Time frame: SAD part: Day 1 to Day 18

    Tmax was summarized by dosing regimen. It was observed directly from data as time of first occurrence.

  3. Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) in SAD

    Time frame: SAD part: Day 1 to Day 18

    AUClast is summarized by dosing regimen and determined by linear/log trapezoidal method.

  4. Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) in SAD

    Time frame: 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).

  5. Terminal Elimination Half-Life (t½) in SAD

    Time frame: 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.

  6. Apparent Clearance (CL/F) in SAD

    Time frame: 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.

  7. Apparent Volume of Distribution (Vz/F) in SAD

    Time frame: 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.

  8. Cmax in Multiple Ascending Dose (MAD)

    Time frame: MAD part: Day 1 to Day 22

    Observed Cmax is estimated based on the plasma concentrations

  9. Time for Cmax (Tmax) in MAD

    Time frame: MAD part: Day 1 to Day 22

    Tmax was summarized by dosing regimen. It was observed directly from data as time of first occurrence.

  10. Area Under the Plasma Concentration-Time Profile From Time Zero To End of Dosing Interval (AUCtau) in MAD

    Time frame: 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.

  11. To evaluate the metabolites of single oral doses of WPV01 and WPV01 in combination with ritonavir in healthy subjects

    Time frame: 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.

  12. Cmax in Food Effect (FE)

    Time frame: 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.

  13. Tmax in FE

    Time frame: 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.

  14. Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) in FE

    Time frame: Day 1to Day 22

    AUClast was summarized using the data in cohort 1 and cohort 2 of FE part.

Sponsors and collaborators

Lead sponsor

Westlake Pharmaceuticals (Hangzhou) Co., Ltd.

Industry

Registry information

Official study title

Phase I Study on the Safety, Tolerability, Pharmacokinetics, and Food Effect Evaluation of WPV01 and WPV01 Co-administrated Ritonavir in Healthy Subjects

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 16, 2024
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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