Pharmacokinetic Study of Single and Multiple Dose of PKL-021 Administered Orally to Healthy Subjects

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pikralida Sp. z o.o.

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

13 Oct 2023 → 21 Dec 2023

Decision date (initial)

2023-10-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Pikralida sp. z.o.o.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Therapy, Safety

The primary objective:
• To determine the pharmacokinetic (PK) profile of single and multiple dose of Test product (T) in healthy adult subjects
• To evaluate the effect of food on the PK profile of single dose of Test Product (T) in healthy adult subjects

Secondary objectives 1

1. To evaluate the safety and tolerability of Test Product (T) of single and multiple oral dose in healthy subjects.

Conditions and MedDRA coding

N/A submitted trial is conducted on healthy subjects

Regulatory references

Scientific advice from competent authorities

Finnish Medicines Agency

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Healthy males and non-pregnant and no breast-feeding females , ≥ 18 and ≤ 55 years of age (on the day of Informed Consent).
2. Non-smoker or past-smoker (who has stopped smoking at least 6 months before the first dosing).
3. Body Mass Index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 (on the day of screening).
4. Subject is available for the whole study and has provided his/her written informed consent.
5. 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
6. All laboratory screening results within the normal range, possible deviations will be deemed clinically insignificant by the Investigator.
7. 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
8. The subject speaks and understands Czech fluently

Exclusion criteria 25

1. 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
2. History of significant hypersensitivity to any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
3. Mental disease and/or inability to cooperate with clinical team.
4. Abuse of drugs, alcohol (≥ 40 g for men or ≥ 20 g for women of pure ethanol per day) or solvents.
5. 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.
6. Clinically significant illness within 28 days before the first dosing, including major surgery.
7. 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.
8. 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.
9. Use of organ-toxic drugs or systemic drugs known to substantially alter liver metabolism within 90 days before the first dosing
10. 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.
11. Donation or loss of 50-499 mL of blood within 30 days before the first dosing.
12. 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.
13. Positive urine drugs abuse test result at screening or at check-in.
14. Positive result of alcohol breath test at screening or at check-in.
15. Positive result of urine cotinine test at screening.
16. 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.
17. Body temperature is out of the range of 35.7-36.9 °C at screening and at check-in.
18. 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.
19. Any significant clinical abnormality, including a positive result of HBsAg and/or HCV and/or HIV test during screening procedure.
20. Anaemia, haemoglobin below 120 g/L for women and 130 g/L for men at the screening.
21. 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).
22. History of previous or current liver diseases with elevations in serum transaminases ALT, AST or GGT, as well as bilirubin, albumin and prothrombin time
23. Acute or chronic diseases/conditions including diseases regarding musculoskeletal system.
24. History of previous or current hyperglycaemia and/or glycosuria.
25. Current or history of thyroid gland disease or level of thyroid hormones out of range, unless evaluated by Investigator as non-significant

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. To determine the pharmacokinetic (PK) profile of single and multiple dose of Test product (T) in healthy adult subjects
2. To evaluate the effect of food on the PK profile of single dose of Test Product (T) in healthy adult subjects

Secondary endpoints 1

1. To evaluate the safety and tolerability of Test Product (T) of single and multiple oral dose in healthy subjects.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pikralida Sp. z o.o.

Sponsor organisation

Pikralida Sp. z o.o.

Address

Ul. Uniwersytetu Poznanskiego 10

City

Poznan

Postcode

61-614

Country

Poland

Scientific contact point

Organisation

Pikralida Sp. z o.o.

Contact name

Stanislaw Pikul

Public contact point

Organisation

Pikralida Sp. z o.o.

Contact name

Stanislaw Pikul

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications