Pharmacokinetic Evaluation of Oral PKL-021 in Single and Multiple Doses in Healthy Volunteers
- Trial ID
- 2023-506633-30-00
- Sponsor
- Pikralida Sp. z o.o.
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the **pharmacokinetics** of single and multiple doses of PKL-021 when administered orally to healthy subjects. This is clinically relevant as it provides essential data on the absorption, distribution, metabolism, and excretion of the drug, which is crucial for determining appropriate dosing regimens and ensuring safety and efficacy in future therapeutic applications.
Participants
The clinical trial involves a study population of **healthy subjects** with an age range categorized as adults. Both **male** and **female** participants are included in the trial, and the study population selection considers a vulnerable population. However, the sponsor has not provided information regarding the total number of participants. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The sponsor has not disclosed any key inclusion or exclusion criteria for this study.
Plans and Procedures
The clinical trial is designed as a **randomized**, **double-blind**, and **controlled** study, focusing on the pharmacokinetics of a single and multiple doses of PKL-021 administered orally to healthy subjects. The trial is categorized under Phase 3, with an estimated recruitment start date of October 16, 2023, and an anticipated end date of February 29, 2024. The study aims to evaluate the pharmacokinetic profile of PKL-021, ensuring the safety and efficacy of the drug in a controlled environment.
Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria will be assessed. This visit will involve a comprehensive evaluation to ensure participants meet the necessary health standards for inclusion in the trial. Following the screening, participants will be randomized into different study arms, receiving either the investigational product or a placebo, in a double-blind manner to maintain the integrity of the study results.
Throughout the trial, participants will attend scheduled follow-up visits, which are critical for monitoring the drug's effects and collecting pharmacokinetic data. These visits will include assessments such as blood sampling, vital signs monitoring, and adverse event reporting. The frequency and number of follow-up visits will be determined by the study protocol, ensuring thorough data collection and participant safety.
The end-of-study visit will mark the conclusion of the participant's involvement in the trial. During this visit, final assessments will be conducted to gather comprehensive data on the drug's pharmacokinetics and any long-term effects. The expected length of participant involvement will span the duration of the trial, from the initial screening to the end-of-study visit, unless early termination is warranted. Conditions that may lead to early termination include significant adverse events, non-compliance with study procedures, or withdrawal of consent by the participant.
Treatment
No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is available from the provided data. Consequently, a detailed description of the experimental treatment cannot be provided.
Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Therefore, a description of these elements is not possible based on the current data.
Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. As such, these aspects cannot be detailed in this description.
Efficacy
The clinical trial is in Phase 3 and is scheduled to begin recruitment on October 16, 2023, with an estimated end date of February 29, 2024. The efficacy of the investigational treatment will be assessed through a series of predefined parameters and endpoints. However, specific details regarding the primary and secondary endpoints, as well as the methods and schedule for measuring, collecting, and analyzing these efficacy parameters, are not provided in the available data. The trial will adhere to standard clinical trial protocols to ensure the reliability and validity of the efficacy assessments.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Healthy males and non-pregnant and no breast-feeding females , ≥ 18 and ≤ 55 years of age (on the day of Informed Consent).
- Non-smoker or past-smoker (who has stopped smoking at least 6 months before the first dosing).
- Body Mass Index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 (on the day of screening).
- Subject is available for the whole study and has provided his/her written informed consent.
- Subjects in good health, as determined by screening medical history, physical examination, vital signs assessments (heart rate, systolic and diastolic blood pressure, and body temperature) and 12-lead ECG. Minor deviations outside the reference ranges will be acceptable, if deemed not clinically significant by the Investigator
- All laboratory screening results within the normal range, possible deviations will be deemed clinically insignificant by the Investigator.
- Acceptance of use of highly effective contraceptive measures during the whole study by female subjects of childbearing potential and contraceptive measures during the whole study by male subjects
- The subject speaks and understands Czech fluently
Exclusion Criteria
- Acute or chronic diseases and/or clinical finding which may interfere with the aims of the study or with the drug’s safety, tolerability, bioavailability and/or pharmacokinetics of the IMP including diseases regarding musculoskeletal (MSS) disorders
- History of significant hypersensitivity to any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
- Mental disease and/or inability to cooperate with clinical team.
- Abuse of drugs, alcohol (≥ 40 g for men or ≥ 20 g for women of pure ethanol per day) or solvents.
- Inability to give up the consumption of foods containing methylxanthine (such as coffee, tea, mate, cocoa, guarana, cola, energy drinks, chocolate...) in the period from 48 hours before each drug administration until the last blood draw in each study period.
- Clinically significant illness within 28 days before the first dosing, including major surgery.
- Any systemic over-the-counter (OTC) drug treatment and/or vitamins and/or herbal treatment (e.g Saint John´s Wort) and/or food supplements within 14 days before the first dosing.
- Any systemic prescription treatment within 28 days before the first dosing, except hormonal contraceptives or substitution taken without significant changes in dose for 90 days prior to the first dosing.
- Use of organ-toxic drugs or systemic drugs known to substantially alter liver metabolism within 90 days before the first dosing
- Donation or loss of at least 500 mL of blood within 90 days or donation of plasma or platelets within 14 days before the first dosing.
- Donation or loss of 50-499 mL of blood within 30 days before the first dosing.
- Getting a tattoo, body piercing or any cosmetic treatment involving skin penetration within 90 days before screening, unless evaluated by Investigator as non-significant for inclusion in the study.
- Positive urine drugs abuse test result at screening or at check-in.
- Positive result of alcohol breath test at screening or at check-in.
- Positive result of urine cotinine test at screening.
- Female subjects with positive result of blood pregnancy test at screening or positive urine pregnancy test at check-in or breast-feeding or lack of results of pregnancy test.
- Body temperature is out of the range of 35.7-36.9 °C at screening and at check-in.
- Sitting blood pressure after a minimum of 5 minutes of rest is out of the range of 90-140 mmHg for systolic BP and/or 60-90 mmHg for diastolic BP and/or heart rate out of the range of 50-100 bpm during the screening procedure.
- Any significant clinical abnormality, including a positive result of HBsAg and/or HCV and/or HIV test during screening procedure.
- Anaemia, haemoglobin below 120 g/L for women and 130 g/L for men at the screening.
- Participation in another clinical study within 30 days (i. e. from the day of exit procedure in previous study until the day of the first dosing of this study).
- History of previous or current liver diseases with elevations in serum transaminases ALT, AST or GGT, as well as bilirubin, albumin and prothrombin time
- Acute or chronic diseases/conditions including diseases regarding musculoskeletal system.
- History of previous or current hyperglycaemia and/or glycosuria.
- Current or history of thyroid gland disease or level of thyroid hormones out of range, unless evaluated by Investigator as non-significant
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Czechia | Not Recruiting | 16 Oct 2023 | 12 |
Sites & Investigators
Research sites
Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
PKL-021 | Test | TABLET | ORAL USE | 400 | 7 | PRD10578085 |
PKL-021 | Test | TABLET | ORAL USE | 400 | 7 | PRD10578084 |
Heparin Léčiva Injekční roztok | Other | INJEKČNÍ ROZTOK | INTRAVENOUS USE | 2.4 | 2 | PRD6653638 |