A Single Dose Study About the Influence of Food on the Oral Bioavailability of Ladarixin Capsule in Healthy Volunteers
Condition: no Condition
Intervention: Ladarixin
Intervention description: 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.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Masking description: This is an open-label trial. No masking procedure will be applied since an open-label design was considered adequate for evaluating objective measures such as pharmacokinetic parameters.
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        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