HealthyPhase 1NCT05294250
Study of the Effect of Food Intake on the Bioavailability of XC8 10 mg Film-coated Tablets
A Phase 1 study testing XC8 in people with Healthy, run by Valenta Pharm JSC at 1 site in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- XC8
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteRussia
- Study dates
- 1 Feb 2022to 26 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
- Consumption of citrus fruits, cranberries and products containing them, preparations or products containing St. John's wort - 7 days before taking the IP. 17.
- Dehydration due to diarrhea, vomiting, or other reason within the last 24 hours prior to IP administration.
- Positive result of examination for antibodies to HIV type 1 and 2, syphilis, markers of hepatitis B and C.
- Positive result of rapid test for COVID-19.
- Positive breath alcohol test.
- Positive urine drug test (cocaine, marijuana, amphetamine, methamphetamine, morphine, barbiturates).
- Pregnancy, breastfeeding, positive urine pregnancy test (for women of preserved reproductive potential).
- Use of hormonal contraceptives (oral, transdermal, injectable, implantable) by a female volunteer for 2 months prior to the drug administration.
- Donation of blood (450 ml or more) within 30 days prior to the study.
- Participation in a clinical drug study of any phase within 90 days prior to the start of the study.
- Unavailability for observation during the study, inability to keep the visit schedule, inability to be hospitalized for the required duration, high likelihood of problems with successful insertion of a venous catheter or performing a forearm vein puncture.
- Belonging to a vulnerable group of volunteers (minors; incapacitated; people with limited free will or possibly participating under compulsion (serving a sentence in prison, being in custody in detention centers, military personnel)), as well as law enforcement officers.
- Other reasons that, in the opinion of the researcher, prevent the participation of the volunteer in the research or create an unreasonable risk.
- Withdrawal criteria:
- Withdrawal of consent to participate in the study.
- SAE, irrespective of causal relationship to drug intake.
- Any other AE if the researcher believes it is in the best interest of the volunteer to discontinue participation in the study.
- Missing two consecutive or four or more blood sampling points to determine pharmacokinetic parameters during the same period of the pharmacokinetics study.
- Violation of study protocol requirements (including because the volunteer refuses to cooperate with the investigator, is late to the clinic, etc.).
- Volunteer is undergoing or requires treatment that may affect the pharmacokinetic parameters of the drug.
- Volunteer requires inpatient treatment while participating in the study.
- Vomiting and/or diarrhea in volunteer within 24 hours prior to the drug administration or within 2 hours (2 maximum Tmax for XC8) after the drug administration.
- Positive urine drug test result.
- Positive breath alcohol test.
- Positive urine pregnancy test.
- Positive test for COVID-19.
- Discontinuation of the study at the discretion of the Sponsor or regulatory agency.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Limited Liability Company "Research Center Eco-Security"
Saint Petersburg, 196143
About this study
Official title: An Open-label, Randomized, Cross-over Study With 2 Treatments (Fasting and After Meals), 3 Periods, 2 Sequences, and an Adaptive, Two-stage Design to Evaluate the Effect of Food Intake on the Bioavailability of XC8, Film-coated Tablets, 10 mg at a Single Dose of 20 mg in Healthy Volunteers
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
- Being tested
- XC8
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XC8Drug
XC8 10 mg film-coated tablets, 3 discrete doses of 20 mg each separated by 7-day wash-out periods
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: XC8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - Cmax
Maximum plasma concentration (Cmax) of XC8 and its metabolite
Measured: 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
Measured: 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
Measured: 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
Number and frequency of adverse events (AEs) or serious AEs (SAEs)
Measured: 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
Description and severity of AEs or serious AEs (SAEs), concomitant therapy for AEs/SAEs, causal relationship with XC221, outcomes
Measured: 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)
SBP, mmHg
Measured: 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)
DBP, mmHg
Measured: 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)
RR, breaths per minute
Measured: 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 - heart rate (HR)
HR, beats per minute
Measured: 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 - body temperature
Body temperature, centigrade scale
Measured: 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: physical examination results
Physical examination results
Measured: 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: urinalysis - color
Color of the urine
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis - transparency
Transparency of the urine
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis - pH
pH of the urine
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis - specific gravity
Specific gravity of the urine
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis - nitrites
Nitrites in the urine (+/-)
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis - protein
Protein in the urine (g/L)
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis - glucose
Glucose in the urine (mmol/L)
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis - ketones
Ketones in the urine (mmol/L)
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis - urobilinogen
Urobilinogen in the urine (mmol/L)
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis - bilirubin
Bilirubin in the urine (+/-)
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis (microscopy) - red blood cells
Red blood cells in the urine (number in sight)
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis (microscopy) - white blood cells
White blood cells in the urine (number in sight)
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis (microscopy) - cylinders (except hyaline)
Cylinders (except hyaline) in the urine (number in sight)
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis (microscopy) - bacteria
Bacteria in the urine (number in sight)
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: complete bood count - hemoglobin
Hemoglobin, g/dL
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: complete bood count - red blood cells
Red blood cells, 10^6/uL
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: complete bood count - hematocrit
Hematocrit, %
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: complete bood count - platelets
Platelets, 10^3/uL
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: complete bood count - white blood cells
White blood cells, 10^3/uL
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: complete bood count - erythrocyte sedimentation rate
Erythrocyte sedimentation rate, mm per hour
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: complete bood count - neutrophils
Neutrophils, %
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: complete bood count - lymphocytes
Lymphocytes, %
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: complete bood count - eosinophils
Eosinophils, %
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: complete bood count - Monocytes
Monocytes, %
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: complete bood count - basophils
Basophils, %
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: blood test results - total protein
Total protein in blood serum, g/L
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: blood test results - creatinine
Creatinine in blood serum, umol/L
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: blood test results - urea
Urea in blood serum, mmol/L
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: blood test results - glucose
Glucose in blood serum, mmol/L
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: blood test results - total bilirubin
Total bilirubin in blood serum, umol/L
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: blood test results - direct bilirubin
Direct bilirubin in blood serum, umol/L
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: blood test results - total cholesterol
Total cholesterol in blood serum, mmol/L
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: blood test results - triglycerides
Triglycerides in blood serum, mmol/L
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: blood test results - alanine transaminase (ALT)
ALT in blood serum, U/L
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: blood test results - aspartate transaminase (AST)
AST in blood serum, U/L
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: blood test results - alkaline phosphatase (ALP)
ALP in blood serum, U/L
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: heart rate (beats per minute)
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: PQ interval (ms)
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QRS complex (ms)
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval (QTc)
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QTc (ms)
Measured: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 Feb 2022
- Primary completion3 Feb 2022
- Study completion26 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Valenta Pharm JSCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valenta Pharm JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294250
- Sponsor's protocol ID
- XC8-01-02-2021
- Status last verified
- Jul 2023
- First submitted
- 28 Jan 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Cross-over Study With 2 Treatments (Fasting and After Meals), 3 Periods, 2 Sequences, and an Adaptive, Two-stage Design to Evaluate the Effect of Food Intake on the Bioavailability of XC8, Film-coated Tablets, 10 mg at a Single Dose of 20 mg in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05294250
- Acronym / sponsor ID
- XC8-01-02-2021
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Valenta Pharm JSCIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 3 Feb 2022 (actual)
- Study completion
- 26 Feb 2022 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XC8, fasted | Experimental | Drug: XC8Administration 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 |
| XC8, fed | Experimental | Drug: XC8Administration 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (42 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XC8XC8 10 mg film-coated tablets, 3 discrete doses of 20 mg each separated by 7-day wash-out periods | Drug | XC8, fasted, XC8, fed |
Primary outcome
Pharmacokinetics - Cmax
Time frame: From 0 to 24 hours after dosing on Day 1-2, Day 8-9, and Day 15-16
Maximum plasma concentration (Cmax) of XC8 and its metabolite
Pharmacokinetics - AUC0-t
Time frame: From 0 to 24 hours after dosing on Day 1-2, Day 8-9, and Day 15-16
Area under the plasma concentration-time curve from time 0 to t (AUC0-t) of XC8 and its metabolite
Pharmacokinetics - AUC0-inf
Time frame: From 0 to 24 hours after dosing on Day 1-2, Day 8-9, and Day 15-16
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) of XC8 and its metabolite
48 secondary outcomes
Safety and Tolerability: adverse event (AE) number and frequency
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 - heart rate (HR)
Time frame: 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 - body temperature
Time frame: 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: physical examination results
Time frame: 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: urinalysis - color
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis - transparency
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis - pH
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis - specific gravity
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis - nitrites
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis - protein
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis - glucose
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis - ketones
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis - urobilinogen
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis - bilirubin
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis (microscopy) - red blood cells
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis (microscopy) - white blood cells
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis (microscopy) - cylinders (except hyaline)
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: urinalysis (microscopy) - bacteria
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: complete bood count - hemoglobin
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: complete bood count - red blood cells
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: complete bood count - hematocrit
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: complete bood count - platelets
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: complete bood count - white blood cells
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: complete bood count - erythrocyte sedimentation rate
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: complete bood count - neutrophils
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: complete bood count - lymphocytes
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: complete bood count - eosinophils
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: complete bood count - Monocytes
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: complete bood count - basophils
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: blood test results - total protein
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: blood test results - creatinine
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: blood test results - urea
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: blood test results - glucose
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: blood test results - total bilirubin
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: blood test results - direct bilirubin
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Safety and Tolerability: blood test results - total cholesterol
Time frame: Screening and Day 16 or on early termination visit within the time frame of the study (from Day -1 to Day 16)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XC8 in people with Healthy, run by Valenta Pharm JSC at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics - Cmax (time frame: From 0 to 24 hours after dosing on Day 1-2, Day 8-9, and Day 15-16). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.