no ConditionPhase 1NCT04854642

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

A Phase 1 study testing Ladarixin in people with no Condition, run by Dompé Farmaceutici S.p.A at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: no Condition
What is being tested?: Ladarixin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteSwitzerland
Study dates: 20 Oct 2020to 9 Dec 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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:

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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.

Who cannot join

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.

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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: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians; vegans
Pregnancy (women only): positive or missing pregnancy test at screening or day -1 of each study period, pregnant or lactating women

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

CROSS Research S.A., I Unit
Arzo, Canton Ticino, 6864

Other trials in Switzerland

About this study

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

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.

Read the 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.

Conditions: no Condition
Being tested: Ladarixin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LadarixinDrug
Also called LDX
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.

Study groups in NCT04854642
Study group	Role	What they receive
T - R (fed then fasting condition)	Experimental	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. Receives: Drug: Ladarixin
R - T (fasting then fed condition)	Experimental	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. Receives: Drug: Ladarixin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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)
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
Measured: 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 outcomes (16)

AUC0-∞ of Plasma DF 2156Y
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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)
Measured: 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)
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
Measured: 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)
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
Measured: 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)
AUC0-∞ 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-∞ = area under the concentration-time curve (AUC) from zero to infinity
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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.
Measured: 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)
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)
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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)
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Oct 20209 Dec 2020

First posted22 Apr 2021
Study start20 Oct 2020
Primary completion9 Dec 2020
Study completion9 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for no ConditionStudies of the same condition, open and under way.
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: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04854642
Sponsor's protocol ID: LDX0219
Status last verified: Dec 2023
First submitted: 15 Apr 2021
Last updated: 17 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04854642
Acronym / sponsor ID: LDX0219
Conditions: no Condition
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Dompé Farmaceutici S.p.AIndustry (pharma, biotech, devices)
Study start: 20 Oct 2020 (actual)
Primary completion: 9 Dec 2020 (actual)
Study completion: 9 Dec 2020 (actual)
First posted: 22 Apr 2021 (actual)
Results: Posted 11 Jan 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

This is a Single center, single dose, open label, randomized, two-way, crossover, food effect on bioavailability study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
T - R (fed then fasting condition)	Experimental	Drug: LadarixinSubjects 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.
R - T (fasting then fed condition)	Experimental	Drug: LadarixinSubjects 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (15 listed)

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

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
LadarixinAlso: LDXA 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.	Drug	R - T (fasting then fed condition), T - R (fed then fasting condition)

Primary outcome

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
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

16 secondary outcomes

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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Results and safety

Results posted to the registry on 11 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
T - R (Fed Then Fasting Condition)	18	17
R - T (Fasting Then Fed Condition)	18	15

Primary outcome: 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). Mean (Standard Deviation). Unit: μg/mL

Measure	Ladarixin Fed (T) n = 33	Ladarixin Fasting (R) n = 35
Value	67.345 (11.426)	95.982 (14.257)

Ladarixin Fed (T) vs Ladarixin Fasting (R): Least square mean difference: 71.62 (90% CI 68.13 to 75.29), p <0.0001, ANOVA

Population analysed: PK set 1: all subjects randomised who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts for DF 2156Y with no major deviations that could affect the PK results. This analysis set was used for the statistical analysis of the PK results for DF 2156Y.

Primary outcome: AUC0-t of Plasma DF 2156Y

Measure	Ladarixin Fed (T) n = 33	Ladarixin Fasting (R) n = 35
Value	1422.500 (362.265)	1564.189 (364.099)

Ladarixin Fed (T) vs Ladarixin Fasting (R): Least square mean difference: 90.93 (90% CI 85.30 to 96.93), p = 0.0170, ANOVA

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the study, from screening to final visit /ETV (at day 4 of period 2 or early termination up to 22 days). Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ladarixin Fed (T)	0 of 33 (0%)	4 of 33 (12.1%)	0 of 33
Ladarixin Fasting (R)	0 of 35 (0%)	4 of 35 (11.4%)	0 of 35

Limitations and caveats (from the sponsor): Limitations and Caveats not specified.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Milko Radicioni, MD principal investigator

CROSS Research S.A., I Unit,

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 Ladarixin in people with no Condition, run by Dompé Farmaceutici S.p.A at 1 site in Switzerland.

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 10 inclusion and 15 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 17 Jan 2024. 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 Switzerland. 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?

Yes. Results are posted in the registry (first posted 11 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04854642.

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 17 Jan 2024.