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A Single Dose Study About the Influence of Food on the Oral Bioavailability of Ladarixin Capsule in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04854642
Recruitment Status : Completed
First Posted : April 22, 2021
Results First Posted : January 11, 2022
Last Update Posted : January 19, 2022
Sponsor:
Information provided by (Responsible Party):
Dompé Farmaceutici S.p.A

Brief 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.

Condition or disease Intervention/treatment Phase
no Condition Drug: Ladarixin Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
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.
Primary Purpose: Treatment
Official Title: Influence of Food on the Oral Bioavailability of Ladarixin 200 mg Capsule in Healthy Volunteers of Both Sexes. A Single Dose (400 mg), Randomized, Open Label, Two-Way Crossover Study
Actual Study Start Date : October 20, 2020
Actual Primary Completion Date : December 9, 2020
Actual Study Completion Date : December 9, 2020

Arm Intervention/treatment
Experimental: T - R (fed then fasting condition)
Subjects were assigned to the sequence of treatments TR to receive Ladarixin in fed conditions (T treatment) during period 1 and in fasting conditions (R treatment) in period 2.
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.
Other Name: LDX

Experimental: R - T (fasting then fed condition)
Subjects were assigned to the sequence of treatments RT to receive Ladarixin ini fasting conditions (R treatment) in period 1 and in fed conditions (T treatment) during period 2.
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.
Other Name: LDX




Primary Outcome Measures :
  1. Cmax of Plasma DF 2156Y [ Time Frame: 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) ]

    PK parameters were assessed after single dose administration of 400 mg of ladarixin under fed and fasting conditions.

    Cmax = maximum plasma concentration


  2. AUC0-t of Plasma DF 2156Y [ Time Frame: 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) ]

    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



Secondary Outcome Measures :
  1. AUC0-∞ of Plasma DF 2156Y [ Time Frame: 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) ]

    PK parameters were assessed after single dose administration of 400 mg of ladarixin under fed and fasting conditions:

    AUC0-∞ = area under the concentration-time curve (AUC) from zero to infinity


  2. Tmax of Plasma DF 2156Y [ Time Frame: 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) ]

    PK parameters were assessed after single dose administration of 400 mg of ladarixin under fed and fasting conditions.

    tmax = time to maximum plasma concentration


  3. t1/2 of Plasma DF 2156Y [ Time Frame: 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) ]

    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


  4. Lambda-zeta of Plasma DF 2156Y [ Time Frame: 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) ]

    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


  5. Frel of Plasma DF 2156Y [ Time Frame: 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) ]

    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)


  6. Cmax of Plasma DF 2108Y (DF 2156Y Metabolite) [ Time Frame: 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) ]

    PK parameters were assessed after single dose of 400 mg of ladarixin under fed and fasting conditions.

    Cmax = maximum plasma concentration


  7. AUC0-t of Plasma DF 2108Y (DF 2156Y Metabolite) [ Time Frame: 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) ]

    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


  8. AUC0-∞ of Plasma DF 2108Y (DF 2156Y Metabolite) [ Time Frame: 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) ]

    PK parameters were assessed after single dose of 400 mg of ladarixin under fed and fasting conditions.

    AUC0-∞ = area under the concentration-time curve (AUC) from zero to infinity


  9. Tmax of Plasma DF 2108Y (DF 2156Y Metabolite) [ Time Frame: 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) ]

    PK parameters were assessed after single dose of 400 mg of ladarixin under fed and fasting conditions.

    tmax = time to maximum plasma concentration


  10. t1/2 of Plasma DF 2108Y (DF 2156Y Metabolite) [ Time Frame: 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) ]

    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


  11. Lambda-zeta of Plasma DF2108Y (DF 2156Y Metabolite) [ Time Frame: 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) ]

    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.


  12. Frel of Plasma DF2108Y (DF 2156Y Metabolite) [ Time Frame: 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) ]

    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)


  13. Cmax of Plasma DF2227Y (DF 2156Y Metabolite) [ Time Frame: 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) ]

    PK parameters were assessed after single dose of 400 mg of ladarixin under fed and fasting conditions.

    Cmax = maximum plasma concentration


  14. AUC0-t of Plasma DF2227Y (DF 2156Y Metabolite) [ Time Frame: 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) ]

    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


  15. Tmax of Plasma DF2227Y (DF 2156Y Metabolite) [ Time Frame: 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) ]

    PK parameters were assessed after single dose of 400 mg of ladarixin under fed and fasting conditions.

    tmax = time to maximum plasma concentration


  16. Frel of Plasma DF222Y (DF 2156Y Metabolite) [ Time Frame: 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) ]

    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)




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04854642


Locations
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Switzerland
CROSS Research S.A., I Unit
Arzo, Canton Ticino, Switzerland, 6864
Sponsors and Collaborators
Dompé Farmaceutici S.p.A
Investigators
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Principal Investigator: Milko Radicioni, MD CROSS Research S.A., I Unit,
  Study Documents (Full-Text)

Documents provided by Dompé Farmaceutici S.p.A:
Study Protocol  [PDF] May 28, 2020
Statistical Analysis Plan  [PDF] February 10, 2021

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Responsible Party: Dompé Farmaceutici S.p.A
ClinicalTrials.gov Identifier: NCT04854642    
Other Study ID Numbers: LDX0219
First Posted: April 22, 2021    Key Record Dates
Results First Posted: January 11, 2022
Last Update Posted: January 19, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No