Study of the Effect of Food Intake on the Bioavailability of XC8 10 mg Film-coated Tablets

NCT05294250 | Completed Phase 1

• 1 other identifier: XC8-01-02-2021
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective of the study: evaluation of the effect of food intake on the bioavailability of XC8, film-coated tablets, 10 mg after a single oral administration in fed or fasted condition at a dose of 20 mg (two tablets). Additional objective of the study: evaluation of pharmacokinetic parameters, safety and tolerability of XC8, film-coated tablets, 10 mg in healthy volunteers after single oral administration in fed or fasted condition in a dose of 20 mg (two tablets).

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics - Cmax

  Maximum plasma concentration (Cmax) of XC8 and its metabolite

  From 0 to 24 hours after dosing on Day 1-2, Day 8-9, and Day 15-16

• Pharmacokinetics - AUC0-t

  Area under the plasma concentration-time curve from time 0 to t (AUC0-t) of XC8 and its metabolite

  From 0 to 24 hours after dosing on Day 1-2, Day 8-9, and Day 15-16

• Pharmacokinetics - AUC0-inf

  Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) of XC8 and its metabolite

  From 0 to 24 hours after dosing on Day 1-2, Day 8-9, and Day 15-16

Secondary Outcomes (48)

• Safety and Tolerability: adverse event (AE) number and frequency

  From the screening (and signing informed consent form) to Day 16 of the study or to an early termination visit within the time frame of the study (from Day -1 to Day 16)

• Safety and Tolerability: adverse event (AE) characteristics

  From the screening (and signing informed consent form) to Day 16 of the study or to an early termination visit within the time frame of the study (from Day -1 to Day 16)

• Safety and Tolerability: vital signs - systolic blood pressure (SBP)

  Screening, from Day -1 to Day 2, from Day 7 to Day 9, from Day 14 to Day 16 and/or on early termination visit within the time frame of the study (from Day -1 to Day 16)

• Safety and Tolerability: vital signs - diastolic blood pressure (DBP)

  Screening, from Day -1 to Day 2, from Day 7 to Day 9, from Day 14 to Day 16 and/or on early termination visit within the time frame of the study (from Day -1 to Day 16)

• Safety and Tolerability: vital signs - respiratory rate (RR)

  Screening, from Day -1 to Day 2, from Day 7 to Day 9, from Day 14 to Day 16 and/or on early termination visit within the time frame of the study (from Day -1 to Day 16)

Study Arms (2)

XC8, fasted

EXPERIMENTAL

Administration of XC8 20 mg in fasted state in Dosing Periods 1 and 2 followed by administration of XC8 20 mg in fasted state in Dosing Period 3

Drug: XC8

XC8, fed

EXPERIMENTAL

Administration of XC8 20 mg in fed state in Dosing Periods 1 and 2 followed by administration of XC8 20 mg in fasted state in Dosing Period 3

Drug: XC8

Interventions

XC8 DRUG

XC8 10 mg film-coated tablets, 3 discrete doses of 20 mg each separated by 7-day wash-out periods

XC8, fasted; XC8, fed

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female volunteers aged 18 to 45 years (inclusive).
• Presence of written consent of the volunteer to participate in the study in accordance with applicable law.
• Body mass index (BMI) within the range of 18.5 ≤ BMI ≤ 30 kg/m2 with a body weight not less than 45 kg and not more than 100 kg.
• Verified diagnosis "healthy": no deviations from the reference values of the data of standard clinical, laboratory and instrumental methods of examination.
• The consent of the volunteer (including the partner) to use adequate methods of contraception during the study and 3 weeks after its completion.
• Hemodynamic and other vital signs within normal limits (reference intervals are 60-90 bpm at rest for heart rate (HR), 16-20 breaths/min for respiratory rate (RR), 35.5 to 36.9°C for body temperature, normal blood pressure (BP) is considered to be systolic blood pressure (SBP) in the range of 110-130 mmHg; diastolic blood pressure (DBP) is 60-85 mmHg).

You may not qualify if:

• Hypersensitivity to the active substance XC8 (N-\[2-(1H-imidazol-4-yl)-ethyl\]-6-oxo-δ-lactam) and/or any other component of the drug product.
• A history of allergy.
• A history of bronchial asthma, recurrent nasal or paranasal sinus polyposis, allergic rhinitis.
• Hereditary lactose intolerance, lactase deficiency and glucose-galactose malabsorption syndrome.
• Chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine, digestive, urinary, hematopoietic, immune and musculoskeletal systems, mental illness in the history.
• Acute infectious diseases (including influenza, acute respiratory infections) within 30 days prior to the study.
• Surgical interventions on the gastrointestinal tract in the anamnesis (except appendectomy).
• Taking any medications, including vitamins, herbal preparations, and dietary supplements within 14 days prior to screening.
• Taking medications that have significant effects on hemodynamics or liver function (barbiturates, omeprazole, cimetidine, etc.) for less than 30 days before screening.
• Vital signs outside the reference intervals: SBP less than 110 mmHg or greater than 130 mmHg; DBP less than 60 mmHg or greater than 85 mmHg; HR less than 60 bpm or greater than 90 bpm; body temperature less than 35.5 or greater than 36.9° C, RR less than 16 or greater than 20 bpm.
• Laboratory values outside the reference intervals.
• Intake of more than 10 units of alcohol per week (where each unit equals 30 ml of spirits or 120 ml of wine or 330 ml of beer) or anamnestic evidence of alcoholism, drug addiction, substance abuse, drug abuse.
• Smoking more than 10 cigarettes per day and failure to abstain from smoking 48 hours before the study and during the hospital stay.
• Special diet (e.g., vegetarian, vegan, restricted salt intake) or lifestyle (night work, extreme physical activity).
• Consumption of alcohol, caffeine, and xanthine-containing products 72 hours before taking the drug product.

Sponsors & Collaborators

• Valenta Pharm JSC: lead

Study Sites (1)

Limited Liability Company "Research Center Eco-Security"

Saint Petersburg, 196143, Russia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: March 24, 2022
• Study Start: February 1, 2022
• Primary Completion: February 3, 2022
• Study Completion: February 26, 2022
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

RU (1)