no ConditionPhase 1NCT04803396
Ascending Dose Tolerability Trial and PK Assessment in Healthy Volunteers After Single & Multiple Oral Intake of DF2755A
A Phase 1 study testing DF2755A in people with no Condition, run by Dompé Farmaceutici S.p.A at 1 site in France.
Trial summary
Primary objective: •To evaluate the tolerability and safety of ascending single doses of DF2755A in healthy adult male and female volunteers. Secondary Objectives: To determine the pharmacokinetics parameters of DF2755A To establish a dose concentration-response relationship over a wide range of doses in order to… 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?
- DF2755A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2018to 29 Jun 2019
- 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
- For eligibility into the trial, subjects had to meet all the following inclusion criteria:
- Healthy male subject, aged between 18 and 55 years inclusive;
- Healthy female subject infertile or in post menopause for at least two years, aged between 18 and 60 years inclusive;
- Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 inclusive and weight ≤ 90kg;
- Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination);
- Normal Blood Pressure (BP) and Heart Rate (HR) at the screening visit after 10 minutes in supine position:
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- 90 mmHg ≤ Systolic Blood Pressure (SBP) ≤ 140 mmHg or 150mmHg for subject > 45 years,
- 50 mmHg ≤ Diastolic Blood Pressure (DBP) ≤ 90 mmHg,
- 40 bpm ≤ HR ≤ 100 bpm, Or considered NCs by investigators;
- Smoker < 5cigarettes per day who stop totally during the study;
- Normal ECG recording on a 12-lead ECG at the screening visit:
- 120 < PR < 210 ms,
- QRS < 120 ms,
- QTcf ≤ 430 ms for male and < 450 ms for female,
- No sign of any trouble of sinusal automatism, Or considered NCs by investigators;
- Normal oral temperature;
- 36.3°C < oral body temperature < 37.5°C;
- Laboratory parameters within the normal range of the laboratory (haematological, blood chemistry tests, urinalysis). Individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator;
- Normal dietary habits;
- Able to communicate well with the Investigator, understand and comply with the requirements of the study, and understand and sign a written informed consent prior to selection;
- Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.
Who cannot join
- Subject has had a clinically significant illness in the six weeks before screening in the opinion of the Investigator.
- Subject has had a serious adverse reaction or significant hypersensitivity to any drug, has a known clinically significant allergy to anti-inflammatory drugs or chemically related compounds or has a clinically significant allergy to drugs, foods or other materials (in the opinion of the Investigator). However, subjects with mild hayfever may be included in the study.
- Subject has used prescription medication in the 14 days prior to dosing or over-the-counter preparations for 7 days prior to dosing (including vitamin supplements and herbal remedies), with the exception of paracetamol which was allowed during the study (maximum 500 mg per administration, total daily dose maximum 2 grams).
- Subject has a significant history of drug/solvent abuse or a positive drugs of abuse (DOA) test at any time during the study.
- Subject has a history of alcohol abuse in the last 5 years or currently drinks in excess of 21 and 14 units per week for males and female, respectively, or has a positive alcohol breath test (ABT) at any time during the study.
- Subject is not willing to refrain from caffeine/xanthine containing products in the 48 hours prior to admission to the clinical unit on Day -1 and for the duration of the residential period.
Show all 13Show fewer
- Subject who has a positive human immunodeficiency virus (HIV) screen, Hepatitis B screen or Hepatitis C screen.
- Subject has donated blood or blood products (e.g., plasma or platelets) within the three months prior to screening.
- Subject who is not suitable to participate in the study in the opinion of the Investigator;
- Subject who has participated in any clinical study with an investigational drug/device within three months prior to the first day of dosing.
- Subject who is in the exclusion period from another study.
- Administrative or legal supervision.
- Subject who would receive more than 4500 euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Ascending Dose Tolerability Study and Pharmacokinetic Assessment in Healthy Male and Female Volunteers After Single & Multiple Oral Administration of DF2755A
Primary objective:
•To evaluate the tolerability and safety of ascending single doses of DF2755A in healthy adult male and female volunteers.
Read more
Secondary Objectives:
- To determine the pharmacokinetics parameters of DF2755A
- To establish a dose concentration-response relationship over a wide range of doses in order to select a narrower range of dose and dosing regimen to be subsequently studied in patients after single administration
- To evaluate the effect of ascending single doses on the pharmacodynamics parameters
- To compare metabolites pathway in Human with the one observed in animals
Please note that the study has been closed after Part A (single ascending doses), so all the objectives were revised accordingly.
Read the detailed description
The study was a phase I, single center, double-blind, placebo controlled, randomized, ascending single doses study in healthy male and female volunteers.
The design consisted of a double blind comparison of the test compound versus placebo in which the dose is increased in successive treatment periods.
The escalating dose had the aim of achieving enough safety information on an interval of doses possibly encompassing both the effective dose and the maximum tolerated dose (defined as the highest dose devoid of any clinical signs/symptoms). Practically, of the two Parts planned - part A and Part B - only the Part A took place.
The Part A consisted of single doses of 50 mg oad, 150 mg oad, 450 mg oad or 700 mg oad of DF2755A tested in healthy male and female volunteers who were hospitalized approximately for 4 days (D-1 morning to D4 morning).
The planned Part B should have consisted of repeated doses of 100 mg bid, 200 mg bid or 300 mg bid of DF2755A) but it was not performed. Hence, the study was terminated at the end of Part A and, consequently, both the methodology and the endpoints were revised accordingly.
- Conditions
- no Condition
- Being tested
- DF2755A, Placebo
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DF2755ADrug
Also called allosteric inhibitor of CXCR1/2
DF2755A was planned to be administered in two different parts:
Part A: Single oral dose administration on D1 according to the randomization (50, 150, 300 and 300 mg oad).
Part B: was planned (100 mg bid, 200 mg bid or 300 mg bid) but not performed (repeated oral administration from Day 1 to Day 14).
PlaceboOther
Also called Matching placebo
Single oral dose administration on D1
| Study group | Role | What they receive |
|---|---|---|
| Placebo RS/PKS/PDS/SS | Placebo comparator | Placebo was administered once a day (oad) as matching oral capsules. The administration took place at around 8:00 a.m with 200 mL of tap water, in sitting position, in fasting conditions. Receives: Other: Placebo |
| DF2755A 50 mg - RS/PKS/PDS/SS | Experimental | The experimental drug was administered once a day (oad) as one oral capsule of 50 mg.
The administration took place at around 8:00 a.m with 200 mL of tap water, in sitting position, in fasting conditions. Receives: Drug: DF2755A |
| DF2755A 150 mg - RS/PKS/PDS/SS | Experimental | The experimental drug was administered once a day (oad) as oral capsules. The administration took place at around 8:00 a.m with 200 mL of tap water, in sitting position, in fasting conditions. Receives: Drug: DF2755A |
| DF2755A 300 mg - RS/PKS/PDS/SS | Experimental | The experimental drug was administered once a day (oad) as oral capsules. The administration took place at around 8:00 a.m with 200 mL of tap water, in sitting position, in fasting conditions. Receives: Drug: DF2755A |
| DF2755A 600 mg - RS/PKS/PDS/SS | Experimental | The experimental drug was administered once a day (oad) as oral capsules. The administration took place at around 8:00 a.m with 200 mL of tap water, in sitting position, in fasting conditions. Receives: Drug: DF2755A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events by Severity
Adverse Event (AE), is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment/product.
Serious Adverse Event or Reaction, is any untoward medical occurrence, that:
- Results in death;
- Is life-threatening
- Requires in patient hospitalization or prolongation of existing hospitalization
- Results in persistent or significant disability or incapacity
- an important medical event/reaction that may jeopardize the patient and require medical / surgical intervention to prevent one of the outcomes above.
Any AE (including laboratory test abnormalities, intercurrent illnesses or injuries, and/or study procedures related AE) reported spontaneously by the subjects, or observed by the Investigator, was recorded according to the procedures in force at Eurofins Optimed.
Measured: Throughout the study, up to Day 4
Secondary outcomes (17)
Cmax of DF2755A
Cmax is the observed maximum plasma concentration of a product.
Measured: Day 1 (0,5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 h post-dose); Day 2 (24, 36, 40h post-dose); Day 3 (48, 60 h post-dose); Day 4 (72 h post dose)
Tmax
It is the first time to reach Cmax.
Measured: Day 1 (0,5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 h post-dose); Day 2 (24, 36, 40h post-dose); Day 3 (48, 60 h post-dose); Day 4 (72 h post dose)
t1/2
It is the plasma concentration half life.
Measured: Day 1 (0,5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 h post-dose); Day 2 (24, 36, 40h post-dose); Day 3 (48, 60 h post-dose); Day 4 (72 h post dose)
AUC0-t
The area under the concentration vs. time curve from time zero (pre-dose) to the time of last quantifiable concentration was calculated using a linear trapezoidal method.
Measured: Day 1 (0,5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 h post-dose); Day 2 (24, 36, 40h post-dose); Day 3 (48, 60 h post-dose); Day 4 (72 h post dose)
AUC 0-inf
It is the area under the plasma concentration-time curve from administration up to infinity with extrapolation of the terminal phase.
Measured: Day 1 (0,5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 h post-dose); Day 2 (24, 36, 40h post-dose); Day 3 (48, 60 h post-dose); Day 4 (72 h post dose)
Vz/F
It is the apparent volume of distribution during terminal phase after non-intravenous administration.
Measured: Day 1 (0,5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 h post-dose); Day 2 (24, 36, 40h post-dose); Day 3 (48, 60 h post-dose); Day 4 (72 h post dose)
CL/F
It is the apparent oral clearance of the drug, where CL = clearance and F = bioavailability.
Measured: Day 1 (0,5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 h post-dose); Day 2 (24, 36, 40h post-dose); Day 3 (48, 60 h post-dose); Day 4 (72 h post dose)
Ae,f(0-72) Total Amount in Faeces
After oral administration, the individual amount of the drug excreted in faeces as DF2755Y is measured by the tracing of the radiolabelled compound [14C]DF2755A.
Measured: 0-24 h post-dose; 24-48 h post-dose, 48-72 h post dose
Fe,f(0-72)
The individual corresponding fraction of DF2755A dose excreted in faeces as DF2755Y over time in the whole sampling window is reported.
Measured: 0-24 h post-dose; 24-48 h post-dose, 48-72 h post dose
Ae,ur(0-72)
The individual amount of DF2755A excreted in urine as DF2755Y over time in the whole sampling window is reported.
Measured: 0-6 h post-dose; 6-10 h post-dose; 10-16h post-dose; 16-24h post-dose; 24-48h post-dose; 48-72h post-dose
Fe,ur(0-72)
The individual corresponding fraction of DF2755A dose excreted in urine as DF2755Y over time in the whole sampling window is reported.
Measured: 0-6 h post-dose; 6-10 h post-dose; 10-16h post-dose; 16-24h post-dose; 24-48h post-dose; 48-72h post-dose
CLR
It is the renal clearance of DF2755Y.
Measured: 0-6 h post-dose; 6-10 h post-dose; 10-16h post-dose; 16-24h post-dose; 24-48h post-dose; 48-72h post-dose
12-lead ECG (HR)
12-lead ECG included the assessment of the following parameters: HR, PR, QRS, QT, and QTcF. Here heart rate (HR) is reported. Heart rate (or pulse rate is the frequency of the heartbeat measured by the number of contractions (beats) of the heart per minute (bpm). The heart rate can vary according to the body's physical needs, including the need to absorb oxygen and excrete carbon dioxide, but is also modulated by numerous factors, including, but not limited to, genetics, physical fitness, stress or psychological status, diet, drugs, hormonal status, environment, and disease/illness as well as the interaction between and among these factors. It is usually equal or close to the pulse measured at any peripheral point.
Measured: day -1 (pre treatment), day 3 (last visit after treatment)
12-lead ECG PR, QRS, QT, and QTcF
It included the assessment of the following parameters: PR, QRS, QT, and QTcF. PR=PR interval measured on ECG; it is the period, measured in milliseconds, that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex (the onset of ventricular depolarization).
QRS=QRS interval measured on ECG; It's the combination of 3 of the graphical deflections seen on a typical ECG. It corresponds to the depolarization of the right and left ventricles of the heart and contraction of the large ventricular muscles.
QT=QT interval; it is used to assess some of the electrical heart properties, calculated as the time from the start of the Q wave to the end of the T wave, and approximates to the time taken from when the cardiac ventricles start to contract to when they finish relaxing.
QtcF=QT interval corrected for heart rate using Fridericia's formula; it's measured with a "QT/QTcF semiautomated triplicate averaging method" (TAM).
Measured: day -1 (pre treatment), day 3 (last visit after treatment)
Systolic and Diastolic Blood Pressure (SBP, DBP)
Vital signs included SBP and DBP in both supine position (after 10 minutes rest) and standing position (after 2 minutes).
SBP= Systolic Blood Pressure is the maximum pressure during one heartbeat. DBP= Diastolic Blood Pressure minimum is the pressure between two heartbeats.
Measured: day -1 (pre treatment), day 2 (post-treatment)
Heart Rate (HR)
Vital signs included HR in both supine position (after 10 minutes rest) and standing position (after 2 minutes).
HR: Heart Rate(or pulse rate) is the frequency of the heartbeat measured by the number of contractions (beats) of the heart per minute (bpm).
Measured: day -1 (pre treatment), day 3 (last visit after treatment)
Oral Body Temperature
The oral body temperature is the measurement of the body temperature placing the thermometer under one side of the back of the tongue. Human body temperature varies. It depends on sex, age, time of day, exertion level, health status (such as illness and menstruation), what part of the body the measurement is taken at, state of consciousness (waking, sleeping, sedated), and emotions. Body temperature range in this study was 36.3 to 37.5 °C.
Measured: day -1 (pre treatment), day 2 (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start15 Nov 2018
- Primary completion29 Jun 2019
- Study completion29 Jun 2019
Why it stopped: The Sponsor decided to not proceed from SAD to MAD to explore the possibility of further studying PD.
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dompé Farmaceutici S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yves Donazzolo, MD, MSc, Principal investigator, Eurofins Optimed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803396
- Sponsor's protocol ID
- BPS0115
- Other IDs
- 2016-003629-41, 2016
- Status last verified
- Nov 2023
- First submitted
- 12 Mar 2021
- Last updated
- 26 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Ascending Dose Tolerability Study and Pharmacokinetic Assessment in Healthy Male and Female Volunteers After Single & Multiple Oral Administration of DF2755A
- ClinicalTrials.gov ID
- NCT04803396
- Acronym / sponsor ID
- BPS0115
- Conditions
- no Condition
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Sponsor decided to not proceed from SAD to MAD to explore the possibility of further studying PD.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Dompé Farmaceutici S.p.AIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 29 Jun 2019 (actual)
- Study completion
- 29 Jun 2019 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Posted 26 Apr 2024
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 evaluate the tolerability and safety of ascending single doses of DF2755A in healthy adult male and female volunteers.
Secondary Objectives:
- To determine the pharmacokinetics parameters of DF2755A
- To establish a dose concentration-response relationship over a wide range of doses in order to select a narrower range of dose and dosing regimen to be subsequently studied in patients after single administration
- To evaluate the effect of ascending single doses on the pharmacodynamics parameters
- To compare metabolites pathway in Human with the one observed in animals
Please note that the study has been closed after Part A (single ascending doses), so all the objectives were revised accordingly.
Detailed description
The study was a phase I, single center, double-blind, placebo controlled, randomized, ascending single doses study in healthy male and female volunteers.
The design consisted of a double blind comparison of the test compound versus placebo in which the dose is increased in successive treatment periods.
The escalating dose had the aim of achieving enough safety information on an interval of doses possibly encompassing both the effective dose and the maximum tolerated dose (defined as the highest dose devoid of any clinical signs/symptoms). Practically, of the two Parts planned - part A and Part B - only the Part A took place.
The Part A consisted of single doses of 50 mg oad, 150 mg oad, 450 mg oad or 700 mg oad of DF2755A tested in healthy male and female volunteers who were hospitalized approximately for 4 days (D-1 morning to D4 morning).
The planned Part B should have consisted of repeated doses of 100 mg bid, 200 mg bid or 300 mg bid of DF2755A) but it was not performed. Hence, the study was terminated at the end of Part A and, consequently, both the methodology and the endpoints were revised accordingly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo RS/PKS/PDS/SS | Placebo comparator | Other: PlaceboPlacebo was administered once a day (oad) as matching oral capsules. The administration took place at around 8:00 a.m with 200 mL of tap water, in sitting position, in fasting conditions. |
| DF2755A 50 mg - RS/PKS/PDS/SS | Experimental | Drug: DF2755AThe experimental drug was administered once a day (oad) as one oral capsule of 50 mg. The administration took place at around 8:00 a.m with 200 mL of tap water, in sitting position, in fasting conditions. |
| DF2755A 150 mg - RS/PKS/PDS/SS | Experimental | Drug: DF2755AThe experimental drug was administered once a day (oad) as oral capsules. The administration took place at around 8:00 a.m with 200 mL of tap water, in sitting position, in fasting conditions. |
| DF2755A 300 mg - RS/PKS/PDS/SS | Experimental | Drug: DF2755AThe experimental drug was administered once a day (oad) as oral capsules. The administration took place at around 8:00 a.m with 200 mL of tap water, in sitting position, in fasting conditions. |
| DF2755A 600 mg - RS/PKS/PDS/SS | Experimental | Drug: DF2755AThe experimental drug was administered once a day (oad) as oral capsules. The administration took place at around 8:00 a.m with 200 mL of tap water, in sitting position, in fasting conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- For eligibility into the trial, subjects had to meet all the following inclusion criteria:
Key exclusion criteria (13 listed)
- Subject has had a clinically significant illness in the six weeks before screening in the opinion of the Investigator.
- Subject has had a serious adverse reaction or significant hypersensitivity to any drug, has a known clinically significant allergy to anti-inflammatory drugs or chemically related compounds or has a clinically significant allergy to drugs, foods or other materials (in the opinion of the Investigator). However, subjects with mild hayfever may be included in the study.
- Subject has used prescription medication in the 14 days prior to dosing or over-the-counter preparations for 7 days prior to dosing (including vitamin supplements and herbal remedies), with the exception of paracetamol which was allowed during the study (maximum 500 mg per administration, total daily dose maximum 2 grams).
- Subject has a significant history of drug/solvent abuse or a positive drugs of abuse (DOA) test at any time during the study.
- Subject has a history of alcohol abuse in the last 5 years or currently drinks in excess of 21 and 14 units per week for males and female, respectively, or has a positive alcohol breath test (ABT) at any time during 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 |
|---|---|---|
| DF2755AAlso: allosteric inhibitor of CXCR1/2DF2755A was planned to be administered in two different parts: Part A: Single oral dose administration on D1 according to the randomization (50, 150, 300 and 300 mg oad). Part B: was planned (100 mg bid, 200 mg bid or 300 mg bid) but not performed (repeated oral administration from Day 1 to Day 14). | Drug | DF2755A 150 mg - RS/PKS/PDS/SS, DF2755A 300 mg - RS/PKS/PDS/SS, DF2755A 50 mg - RS/PKS/PDS/SS, DF2755A 600 mg - RS/PKS/PDS/SS |
| PlaceboAlso: Matching placeboSingle oral dose administration on D1 | Other | Placebo RS/PKS/PDS/SS |
Primary outcome
Number of Adverse Events by Severity
Time frame: Throughout the study, up to Day 4
Adverse Event (AE), is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment/product. Serious Adverse Event or Reaction, is any untoward medical occurrence, that: * Results in death; * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity * an important medical event/reaction that may jeopardize the patient and require medical / surgical intervention to prevent one of the outcomes above. Any AE (including laboratory test abnormalities, intercurrent illnesses or injuries, and/or study procedures related AE) reported spontaneously by the subjects, or observed by the Investigator, was recorded according to the procedures in force at Eurofins Optimed.
17 secondary outcomes
Cmax of DF2755A
Time frame: Day 1 (0,5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 h post-dose); Day 2 (24, 36, 40h post-dose); Day 3 (48, 60 h post-dose); Day 4 (72 h post dose)
Tmax
Time frame: Day 1 (0,5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 h post-dose); Day 2 (24, 36, 40h post-dose); Day 3 (48, 60 h post-dose); Day 4 (72 h post dose)
t1/2
Time frame: Day 1 (0,5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 h post-dose); Day 2 (24, 36, 40h post-dose); Day 3 (48, 60 h post-dose); Day 4 (72 h post dose)
AUC0-t
Time frame: Day 1 (0,5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 h post-dose); Day 2 (24, 36, 40h post-dose); Day 3 (48, 60 h post-dose); Day 4 (72 h post dose)
AUC 0-inf
Time frame: Day 1 (0,5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 h post-dose); Day 2 (24, 36, 40h post-dose); Day 3 (48, 60 h post-dose); Day 4 (72 h post dose)
Vz/F
Time frame: Day 1 (0,5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 h post-dose); Day 2 (24, 36, 40h post-dose); Day 3 (48, 60 h post-dose); Day 4 (72 h post dose)
CL/F
Time frame: Day 1 (0,5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 h post-dose); Day 2 (24, 36, 40h post-dose); Day 3 (48, 60 h post-dose); Day 4 (72 h post dose)
Ae,f(0-72) Total Amount in Faeces
Time frame: 0-24 h post-dose; 24-48 h post-dose, 48-72 h post dose
Fe,f(0-72)
Time frame: 0-24 h post-dose; 24-48 h post-dose, 48-72 h post dose
Ae,ur(0-72)
Time frame: 0-6 h post-dose; 6-10 h post-dose; 10-16h post-dose; 16-24h post-dose; 24-48h post-dose; 48-72h post-dose
Fe,ur(0-72)
Time frame: 0-6 h post-dose; 6-10 h post-dose; 10-16h post-dose; 16-24h post-dose; 24-48h post-dose; 48-72h post-dose
CLR
Time frame: 0-6 h post-dose; 6-10 h post-dose; 10-16h post-dose; 16-24h post-dose; 24-48h post-dose; 48-72h post-dose
12-lead ECG (HR)
Time frame: day -1 (pre treatment), day 3 (last visit after treatment)
12-lead ECG PR, QRS, QT, and QTcF
Time frame: day -1 (pre treatment), day 3 (last visit after treatment)
Systolic and Diastolic Blood Pressure (SBP, DBP)
Time frame: day -1 (pre treatment), day 2 (post-treatment)
Heart Rate (HR)
Time frame: day -1 (pre treatment), day 3 (last visit after treatment)
Oral Body Temperature
Time frame: day -1 (pre treatment), day 2 (post-treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Yves Donazzolo, MD, MSc principal investigator
Eurofins Optimed
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 DF2755A in people with no Condition, run by Dompé Farmaceutici S.p.A at 1 site in France.
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 21 inclusion and 13 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: stopped early, as of the sponsor's last update on 26 Apr 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 France. 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. Some participants in this study may receive a placebo. 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 26 Apr 2024). 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?
Number of Adverse Events by Severity (time frame: Throughout the study, up to Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2024.