Phase 1
N=36
A Single Dose Study About the Influence of Food on the Oral Bioavailability of Ladarixin Capsule in Healthy Volunteers
no Condition
Bottom Line
View on ClinicalTrials.gov: NCT04854642 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Cmax of Plasma DF 2156Y — 67.345; 95.982 μg/mL — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Ladarixin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dompé Farmaceutici S.p.A
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax of Plasma DF 2156Y |
67.345; 95.982 | <0.0001 sig |
| PRIMARY AUC0-t of Plasma DF 2156Y |
1422.500; 1564.189 | 0.0170 sig |
| SECONDARY AUC0-∞ of Plasma DF 2156Y |
1533.432; 1677.749 | 0.0213 sig |
| SECONDARY Tmax of Plasma DF 2156Y |
5.485; 1.914 | <0.0001 sig |
| SECONDARY t1/2 of Plasma DF 2156Y |
16.918; 17.087 | — |
| SECONDARY Lambda-zeta of Plasma DF 2156Y |
0.046; 0.045 | — |
| SECONDARY Frel of Plasma DF 2156Y |
93.721 | — |
| SECONDARY Cmax of Plasma DF 2108Y (DF 2156Y Metabolite) |
0.940; 0.972 | — |
| SECONDARY AUC0-t of Plasma DF 2108Y (DF 2156Y Metabolite) |
47.013; 50.462 | — |
| SECONDARY AUC0-∞ of Plasma DF 2108Y (DF 2156Y Metabolite) |
78.549; 77.220 | — |
| SECONDARY Tmax of Plasma DF 2108Y (DF 2156Y Metabolite) |
28.364; 24.343 | — |
| SECONDARY t1/2 of Plasma DF 2108Y (DF 2156Y Metabolite) |
40.637; 36.444 | — |
| SECONDARY Lambda-zeta of Plasma DF2108Y (DF 2156Y Metabolite) |
0.022; 0.023 | — |
| SECONDARY Frel of Plasma DF2108Y (DF 2156Y Metabolite) |
95.569 | — |
| SECONDARY Cmax of Plasma DF2227Y (DF 2156Y Metabolite) |
0.882; 0.964 | — |
| SECONDARY AUC0-t of Plasma DF2227Y (DF 2156Y Metabolite) |
52.928; 58.465 | — |
| SECONDARY Tmax of Plasma DF2227Y (DF 2156Y Metabolite) |
36.606; 31.657 | — |
| SECONDARY Frel of Plasma DF222Y (DF 2156Y Metabolite) |
92.745 | — |
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
- Informed consent: signed written informed consent before inclusion in the study
- Sex and Age: men/women, 18-55 years old inclusive
- Body Mass Index: 18.5-30 kg/m2 inclusive
- 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
- 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
- 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:
- Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit until 30 days after final visit
- 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
- A male sexual partner who agrees to use a male condom with spermicide until 30 days after final visit
- 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
- Electrocardiogram (ECG) 12-leads (supine position): clinically significant abnormalities
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
- Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
- 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
- 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
- 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.
- 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
- Blood donation: blood donations for 3 months before this study
- 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)
- SARS-COV2 test: positive SARS-COV2 test on day -3 or -2 of each study period
- Virology: positive Hepatitis B (HBs antigen), Hepatitis C (HCV antibodies), HIV 1/2 (HIV Ag/Ab combo) at screening.
- Drug test: positive result at the drug test at screening or day -1 of each study period
- Alcohol test: positive alcohol breath test at screening or day -1 of each study period
- Diet: ab
Data sourced from ClinicalTrials.gov (NCT04854642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.