Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04854642
Other study ID # LDX0219
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 20, 2020
Est. completion date December 9, 2020

Study information

Verified date December 2023
Source Dompé Farmaceutici S.p.A
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Primary objective: - to investigate the effect of food on the bioavailability of DF 2156Y after single dose administration of 400 mg of ladarixin to healthy male and female volunteers under fed and fasting conditions. Secondary objectives: - to investigate the effect of gender on the bioavailability of DF 2156Y and its metabolites (DF 2108Y and DF 2227Y) after single dose administration of 400 mg of ladarixin to healthy male and female volunteers - to evaluate safety and tolerability of a single dose administration of ladarixin 400 mg to healthy male and female volunteers.


Description:

This is a Single center, single dose, open label, randomized, two-way, crossover, food effect on bioavailability study. More precisely, a single oral dose of 400 mg of ladarixin (two 200 mg capsules) was administered to healthy male and female volunteers under fed (Test treatment) and fasting (Reference treatment) conditions in two consecutive study periods, according to a two-way crossover design, with a wash-out interval of at least 14 days between the two administrations.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date December 9, 2020
Est. primary completion date December 9, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: 1. Informed consent: signed written informed consent before inclusion in the study 2. Sex and Age: men/women, 18-55 years old inclusive 3. Body Mass Index: 18.5-30 kg/m2 inclusive 4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, pulse rate 50-90 bpm and body temperature 35.5-37.5° C, measured after 5 min at rest in the sitting position 5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study 6. Contraception and fertility (women only): women of child-bearing potential must not wish to get pregnant within 30 days after the end of the study and must be using at least one of the following reliable methods of contraception: 1. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit until 30 days after final visit 2. A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit until 30 days after final visit 3. A male sexual partner who agrees to use a male condom with spermicide until 30 days after final visit 4. A sterile sexual partner Women participants of non-childbearing potential or in post-menopausal status for at least one year will be admitted. For all women, pregnancy test result must be negative at screening and day -1. Exclusion Criteria: 1. Electrocardiogram (ECG) 12-leads (supine position): clinically significant abnormalities 2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study 3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness 4. Allergy: ascertained or presumptive hypersensitivity to the active principles (ladarixin or derivatives) and/or formulations' ingredients; known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs); history of hypersensitivity to drugs (in particular methanesulfonyl propanamide) or allergic reactions in general, which the Investigator considers may affect the outcome of the study 5. Diseases: hypoalbuminemia or significant history of renal, hepatic, gastrointestinal, respiratory, skin, hematological, endocrine, neurological or cardiovascular diseases that may interfere with the aim of the study 6. Medications: medications, including over the counter drugs (in particular nonsteroidal anti-inflammatory drugs), herbal remedies and food supplements taken 14 days before the start of the study (in any case at least 5 times the half-life of the drug or a minimum of 14 days, whichever is longer), with the exception of paracetamol. Hormonal contraceptives and hormonal replacement therapy for women will be allowed. 7. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study 8. Blood donation: blood donations for 3 months before this study 9. Drug, alcohol, caffeine, tobacco: history of drug, alcohol (>1 drink/day for women and >2 drinks/day for men, defined according to the USDA Dietary Guidelines 2015-2020), caffeine (>5 cups coffee/tea/day) or tobacco abuse (=10 cigarettes/day) 10. SARS-COV2 test: positive SARS-COV2 test on day -3 or -2 of each study period 11. Virology: positive Hepatitis B (HBs antigen), Hepatitis C (HCV antibodies), HIV 1/2 (HIV Ag/Ab combo) at screening. 12. Drug test: positive result at the drug test at screening or day -1 of each study period 13. Alcohol test: positive alcohol breath test at screening or day -1 of each study period 14. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians; vegans 15. Pregnancy (women only): positive or missing pregnancy test at screening or day -1 of each study period, pregnant or lactating women

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ladarixin
A single oral dose of 400 mg of ladarixin (two 200 mg capsules) was administered to healthy male and female volunteers under fed (Test treatment) and fasting (Reference treatment) conditions in two consecutive study periods, according to a two-way crossover design, with a wash-out interval of at least 14 days between the two administrations.

Locations

Country Name City State
Switzerland CROSS Research S.A., I Unit Arzo Canton Ticino

Sponsors (1)

Lead Sponsor Collaborator
Dompé Farmaceutici S.p.A

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cmax of Plasma DF 2156Y PK parameters were assessed after single dose administration of 400 mg of ladarixin under fed and fasting conditions.
Cmax = maximum plasma concentration
At day 1 (15 min, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours postdose); at days 2 and 3 (24, 30, 36, 48, 54 and 60 hours post-dose); at day 4 (72 hours post-dose)
Primary AUC0-t of Plasma DF 2156Y PK parameters were assessed after single dose administration of 400 mg of ladarixin under fed and fasting conditions.
AUC0-t = area under the concentration-time curve (AUC) from zero to the last quantifiable concentrations
At day 1 (15 min, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours postdose); at days 2 and 3 (24, 30, 36, 48, 54 and 60 hours post-dose); at day 4 (72 hours post-dose)
Secondary AUC0-8 of Plasma DF 2156Y PK parameters were assessed after single dose administration of 400 mg of ladarixin under fed and fasting conditions:
AUC0-8 = area under the concentration-time curve (AUC) from zero to infinity
At day 1 (15 min, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours postdose); at days 2 and 3 (24, 30, 36, 48, 54 and 60 hours post-dose); at day 4 (72 hours post-dose)
Secondary Tmax of Plasma DF 2156Y PK parameters were assessed after single dose administration of 400 mg of ladarixin under fed and fasting conditions.
tmax = time to maximum plasma concentration
At day 1 (15 min, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours postdose); at days 2 and 3 (24, 30, 36, 48, 54 and 60 hours post-dose); at day 4 (72 hours post-dose)
Secondary t1/2 of Plasma DF 2156Y PK parameters were assessed after single dose administration of 400 mg of ladarixin under fed and fasting conditions.
t1/2 = half life, is the time required for a quantity to reduce to half of its initial value
At day 1 (15 min, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours postdose); at days 2 and 3 (24, 30, 36, 48, 54 and 60 hours post-dose); at day 4 (72 hours post-dose)
Secondary Lambda-zeta of Plasma DF 2156Y PK parameters were assessed after single dose administration of 400 mg of ladarixin under fed and fasting conditions.
lambda-zeta is the Individual estimate of the terminal elimination rate constant, calculated using log-linear regression of the terminal portions of the plasma concentration-versus-time curves
At day 1 (15 min, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours postdose); at days 2 and 3 (24, 30, 36, 48, 54 and 60 hours post-dose); at day 4 (72 hours post-dose)
Secondary Frel of Plasma DF 2156Y PK parameters were assessed after single dose administration of 400 mg of ladarixin under fed and fasting conditions.
Frel: Relative bioavailability, calculated as ratio AUC0-t (T)/ AUC0-t (R) (multiplicated by 100)
At day 1 (15 min, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours postdose); at days 2 and 3 (24, 30, 36, 48, 54 and 60 hours post-dose); at day 4 (72 hours post-dose)
Secondary Cmax of Plasma DF 2108Y (DF 2156Y Metabolite) PK parameters were assessed after single dose of 400 mg of ladarixin under fed and fasting conditions.
Cmax = maximum plasma concentration
At day 1 (15 min, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours postdose); at days 2 and 3 (24, 30, 36, 48, 54 and 60 hours post-dose); at day 4 (72 hours post-dose)
Secondary AUC0-t of Plasma DF 2108Y (DF 2156Y Metabolite) PK parameters were assessed after single dose of 400 mg of ladarixin under fed and fasting conditions.
AUC0-t = area under the concentration-time curve (AUC) from zero to the last quantifiable concentrations
At day 1 (15 min, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours postdose); at days 2 and 3 (24, 30, 36, 48, 54 and 60 hours post-dose); at day 4 (72 hours post-dose)
Secondary AUC0-8 of Plasma DF 2108Y (DF 2156Y Metabolite) PK parameters were assessed after single dose of 400 mg of ladarixin under fed and fasting conditions.
AUC0-8 = area under the concentration-time curve (AUC) from zero to infinity
At day 1 (15 min, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours postdose); at days 2 and 3 (24, 30, 36, 48, 54 and 60 hours post-dose); at day 4 (72 hours post-dose)
Secondary Tmax of Plasma DF 2108Y (DF 2156Y Metabolite) PK parameters were assessed after single dose of 400 mg of ladarixin under fed and fasting conditions.
tmax = time to maximum plasma concentration
At day 1 (15 min, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours postdose); at days 2 and 3 (24, 30, 36, 48, 54 and 60 hours post-dose); at day 4 (72 hours post-dose)
Secondary t1/2 of Plasma DF 2108Y (DF 2156Y Metabolite) PK parameters were assessed after single dose of 400 mg of ladarixin under fed and fasting conditions.
t1/2 = half life, is the time required for a quantity to reduce to half of its initial value
At day 1 (15 min, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours postdose); at days 2 and 3 (24, 30, 36, 48, 54 and 60 hours post-dose); at day 4 (72 hours post-dose)
Secondary Lambda-zeta of Plasma DF2108Y (DF 2156Y Metabolite) PK parameters were assessed after single dose administration of 400 mg of ladarixin under fed and fasting conditions.
Lambda-zeta is the individual estimate of the terminal elimination rate constant, calculated using log-linear regression of the terminal portions of the plasma concentration-versus-time curves.
At day 1 (15 min, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours postdose); at days 2 and 3 (24, 30, 36, 48, 54 and 60 hours post-dose); at day 4 (72 hours post-dose)
Secondary Frel of Plasma DF2108Y (DF 2156Y Metabolite) PK parameters were assessed after single dose administration of 400 mg of ladarixin under fed and fasting conditions.
Frel: Relative bioavailability, calculated as ratio AUC0-t (T)/ AUC0-t (R) (multiplicated by 100)
At day 1 (15 min, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours postdose); at days 2 and 3 (24, 30, 36, 48, 54 and 60 hours post-dose); at day 4 (72 hours post-dose)
Secondary Cmax of Plasma DF2227Y (DF 2156Y Metabolite) PK parameters were assessed after single dose of 400 mg of ladarixin under fed and fasting conditions.
Cmax = maximum plasma concentration
At day 1 (15 min, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours postdose); at days 2 and 3 (24, 30, 36, 48, 54 and 60 hours post-dose); at day 4 (72 hours post-dose)
Secondary AUC0-t of Plasma DF2227Y (DF 2156Y Metabolite) PK parameters were assessed after single dose of 400 mg of ladarixin under fed and fasting conditions.
AUC0-t = area under the concentration-time curve (AUC) from zero to the last quantifiable concentrations
At day 1 (15 min, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours postdose); at days 2 and 3 (24, 30, 36, 48, 54 and 60 hours post-dose); at day 4 (72 hours post-dose)
Secondary Tmax of Plasma DF2227Y (DF 2156Y Metabolite) PK parameters were assessed after single dose of 400 mg of ladarixin under fed and fasting conditions.
tmax = time to maximum plasma concentration
At day 1 (15 min, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours postdose); at days 2 and 3 (24, 30, 36, 48, 54 and 60 hours post-dose); at day 4 (72 hours post-dose)
Secondary Frel of Plasma DF222Y (DF 2156Y Metabolite) PK parameters were assessed after single dose administration of 400 mg of ladarixin under fed and fasting conditions.
Frel: Relative bioavailability, calculated as ratio AUC0-t (T)/ AUC0-t (R) (multiplicated by 100)
At day 1 (15 min, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hours postdose); at days 2 and 3 (24, 30, 36, 48, 54 and 60 hours post-dose); at day 4 (72 hours post-dose)
See also
  Status Clinical Trial Phase
Completed NCT02265224 - Bioequivalence Study of Two Different Formulations of N-acetyl-cysteine (NAC) Phase 1
Completed NCT00379210 - Neural Effects of Mindfulness Training on Attention N/A
Completed NCT05901220 - Joint School-Health Project of the Neapolitan Child N/A
Active, not recruiting NCT04455295 - Testing the Noradrenergic Hypothesis of Transcutaneous Vagus Nerve Stimulation N/A
Not yet recruiting NCT03225638 - Performance Evaluation by Magnetic Resonance Imaging (MRI) of Intramuscular Thigh Injections With 3 Configurations of Needle-free Injector (ZENEO®) N/A
Completed NCT04803396 - Ascending Dose Tolerability Trial and PK Assessment in Healthy Volunteers After Single & Multiple Oral Intake of DF2755A Phase 1
Recruiting NCT03134482 - Comparison of Clinical Outcomes Between IVM and Minimal Stimulation IVF in Patients With PCOS N/A
Recruiting NCT05882942 - Matcha Green Tea Effects at Rest and During Moderate-intensity Exercise in Females N/A
Completed NCT03044301 - Performance Thresholds Evaluation by Wet Injection Quantification and Magnetic Resonance Imaging (MRI) of Subcutaneous and Intramuscular Injections (0,65ml) of Several Configurations of Needle-free Devices (ZENEO®) N/A
Completed NCT01563224 - GABA-B Receptor Function in Healthy Volunteers N/A
Terminated NCT04227405 - TOGETHER: A Couple's Model to Enhance Relationships and Economic Stability N/A
Completed NCT04802967 - A Study on Ketoprofen Lysine Salt (KLS) + Gabapentin (GABA) vs KLS to Investigate Their Pharmacodynamic in Healthy Males Phase 1