Drug Drug InteractionPhase 1NCT05845567
The Potential of Givinostat as DDI Victim in Co-administration P-gp Inhibitor (Part 2)
A Phase 1 study testing Givinostat and Clarithromycin in people with Drug Drug Interaction, run by Italfarmaco at 1 site in Portugal.
Trial summary
Primary objective: To assess the potential effect of oral Clarithromycin on the single-dose pharmacokinetics of Givinostat. Secondary objective: To assess the safety and tolerability of concomitant administration of Givinostat plus Clarithromycin. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Drug Interaction
- What is being tested?
- Givinostat and Clarithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePortugal
- Study dates
- 21 Mar 2022to 24 May 2022
- 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
- A subject was considered eligible for the study if he/she fulfilled all the inclusion criteria:
- Subject's written informed consent obtained prior to any study-related procedure.
- Male or female subject, ≥18 and ≤55 years of age, at the time of signing the informed consent.
- Body mass index (BMI) of 18.5 to 32.0 kg/m2 inclusive, and body weight ≥55 kg and ≤100 kg for females and body weight ≥60 kg and ≤110 kg for males.
- Non-smoker or ex-smoker (i.e. someone who abstained from using tobacco or nicotine-containing products for at least 3 months prior to Screening).
- No clinically relevant diseases.
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- No major surgery within 4 weeks prior to dosing.
- No clinically relevant abnormalities on physical examination.
- No clinically relevant abnormalities on 12-lead ECG.
- No clinically relevant abnormalities on clinical laboratory tests.
- Negative test results for anti-Human Immunodeficiency virus 1 and 2 antibodies (anti-HIV-1Ab and anti-HIV-2Ab), Hepatitis B surface antigen (HBsAg) and anti-Hepatitis C virus antibodies (anti-HCVAb).
- Female subjects are eligible if they are of non-childbearing potential or agree to use a non-hormonal highly effective contraceptive method from 28 days prior to Screening until at least 90 days after the last study drug administration. Nonchildbearing potential female is defined as:
- Menopausal, i.e. no menses for ≥ 12 months without an alternative medical cause other than menopause, and a high FSH level.
- Pre-menopausal female with documented hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy.
- A non-hormonal effective contraceptive method is defined as:
- Intrauterine device.
- Bilateral tubal occlusion.
- Total abstinence of heterosexual intercourse, in accordance with the lifestyle of the subject.
- Vasectomized partner, who has received medical assessment of the surgical success, or clinically diagnosed infertile partner.
- Male subjects who are sexually active with a female partner of childbearing potential (pregnant or non-pregnant) must use contraception (condom) from investigational product administration up to at least 90 days following the last study drug administration.
- Male subjects must ensure that his non-pregnant female partner of childbearing potential agrees to consistently and correctly use for the same period a highly effective method of contraception (see Section 8.5.3).
- Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.
- Willingness and capability to comply with the requirements of the study and ability to understand the study procedures and the risks involved.
Who cannot join
- A subject was excluded from the study if he/she fulfilled any of the exclusion criteria:
- At Screening
- Previous use of Givinostat.
- History of anaphylaxis reaction or clinically significant drug hypersensitivity reaction (e.g., angioedema, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, drug-induced hypersensitivity syndrome, druginduced neutropenia).
- Known history of hypersensitivity and/or allergic reactions to Givinostat, histone deacetylases (HDAC) inhibitors or to any excipient in the formulation.
- History of sorbitol intolerance, sorbitol malabsorption or fructose intolerance.
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- Any medical condition (e.g. gastrointestinal, renal or hepatic, including peptic ulcer, inflammatory bowel disease or pancreatitis) or surgical condition (e.g. cholecystectomy, gastrectomy) that may affect drug pharmacokinetics (absorption, distribution, metabolism or excretion) or subject safety.
- Systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 60 or over 90 mmHg, or pulse rate lower than 50 or over 100 bpm.
- QTcF ˃450 msec.
- Subjects with history of cardiac arrhythmias (documented), family history of sudden cardiac death or history of additional risk factors for torsades-depointes (e.g. heart failure, hypokalemia, long QT syndrome).
- Having an estimated glomerular filtration (eGFR) < 90 mL/min, based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average surface area of 1.73 m2.
- Any of the following abnormal laboratory test values:
- Platelet count below the lower limit of the normal range (LLN).
- Total white blood cells count below the LLN.
- Hemoglobin below the LLN.
- Triglycerides above the upper limit of normal range (ULN).
- Potassium or magnesium below the LLN.
- Positive urine alcohol, drugs-of-abuse or cotinine screen tests.
- Positive serum pregnancy test.
- If woman, she is breast-feeding.
- History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit (i.e. more than 14 units of alcohol per week for males or more than 7 units for females).
- History of drug abuse within 1 year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs [such as cocaine, phencyclidine (PCP), crack, opioid derivatives including heroin, and amphetamine derivatives] within 1 year prior to screening.
- Participation in any clinical trial within the previous 2 months.
- Participation in more than 2 clinical trials within the previous 12 months.
- Blood donation or significant blood loss (≥ 450 mL) due to any reason or had plasmapheresis within the previous 2 months.
- Veins unsuitable for intravenous puncture on either arm.
- Difficulty in swallowing capsules, tablets or suspensions.
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
- Known history of hypersensitivity and/or allergic reactions to clarithromycin, other macrolides or to any excipient in the formulation.
- At Admission to Treatment Period
- Any clinically relevant abnormalities on clinical laboratory tests.
- Positive urine alcohol, drugs-of-abuse or cotinine screen tests.
- Positive urine pregnancy test.
- Positive or inconclusive SARS-CoV-2 test prior to admission.
- Use of prescription or non-prescription medicinal products within the previous 28 days or within 5-half-lives of the medicinal product, whichever is longer.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Hospital da Prelada, 3rd Floor & East Wing 4th Floor Rua Sarmento de Beires
Porto, 153
About this study
Official title: An Open-label, Single-center, Study in Healthy Subjects to Investigate the Effect of Oral Clarithromycin on the Pharmacokinetics of Givinostat (PART 2)
Primary objective:
To assess the potential effect of oral Clarithromycin on the single-dose pharmacokinetics of Givinostat.
Secondary objective:
To assess the safety and tolerability of concomitant administration of Givinostat plus Clarithromycin.
Read the detailed description
This study was planned as a phase I, open-label, 3-part, fixed-sequence, non-randomized study in healthy male and female subjects. The study (Part 2) aimed at assessing the potential effect of Clarythromycin on the single dose pharmacokynetics of Givinostat.
The total duration of Part 2 was divided as follows:
- Screening: up to 21 days.
- Treatment Period: Days 1 to 11.
- Safety follow-up visit: 12±2 days.
Subjects were confined at site from Day -1 to Day 11. On Days 1 and 8, a single dose of 50 mg Givinostat, as oral suspension, was administered 1 hour after the planned morning time of Clarithromycin administration.
From Day 4 to Day 10, clarithromycin 500 mg film-coated tablets were administered twice a day, in the morning and in the evening.
The following assessments were performed:
- Blood collection for pharmacokinetic analysis on Days 1 to 4 and 8 to 11.
- Vital signs measurements on Days 1 and 4 to 10.
- 12-lead ECG on Days 1, 3, 7 and 8.
- Blood collection for laboratory tests (hematology and biochemistry) on Day 3.
Subjects were discharged in the morning of Day 11 after completing end of study procedures.
- Conditions
- Drug Drug Interaction
- Being tested
- Givinostat, Clarithromycin
- Keywords
- PK, Pharmacokinetics, Givinostat, Clarythromycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GivinostatDrug
Also called ITF2357
ITF2357 Givinostat 10mg/mL. Dose: 10 mg/mL; Dosage form: oral suspension.
ClarithromycinDrug
Also called Klacid®
Clarithromycin 500 mg immediate-release oral film-coated tablet (Klacid®) was administered twice a day, in the morning and in the evening.
| Study group | Role | What they receive |
|---|---|---|
| Givinostat + Clarithromycin | Experimental | Givinostat and Clarithromycin Days 1 and 8, Givinostat 50 mg as oral suspension was administered as a single dose, 1 hour after Clarithromycin administration. From Day 4 to Day 10, Clarithromycin 500 mg film-coated tablet was administered twice a day. Receives: Drug: Givinostat; Drug: Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Givinostat, Following Single Doses of the Parent Drug
Maximum observed plasma concentration (Cmax) of givinostat.
A total of 40 blood samples were collected as follows:
- Twenty (20) blood samples at pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60 and 72 hours after the administration of givinostat, on Days 1 and 8, for the determination of Givinostat.
Measured: In the turn of 72 hours after administration of Givinostat
AUC0-t of Givinostat, Following Single Doses of the Parent Drug
AUC0-t = area under the curve from time zero to last sampling time with quantifiable concentrations.
A total of 40 blood samples were collected as follows:
- Twenty (20) blood samples at pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60 and 72 hours after the administration of Givinostat, on Days 1 and 8, for the determination of Givinostat.
Measured: In the turn of 72 hours after administration of Givinostat
AUC0-inf of Givinostat, Following Single Doses of the Parent Drug
AUC0-inf=Total AUC extrapolated to infinity, calculated as AUC0-t + Clast/λz, where Clast is the last measurable concentration and λz is the apparent terminal elimination rate constant.
A total of 40 blood samples were collected as follows:
- Twenty (20) blood samples at pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60 and 72 hours after the administration of givinostat, on Days 1 and 8, for the determination of givinostat.
Measured: In the turn of 72 hours after administration of Givinostat
%AUCextrap of Givinostat, Following Single Doses of the Parent Drug
%AUC0extrap = Percentage of AUC0-∞ due to extrapolation from the time of the last measurable concentration (tlast) to infinity, i.e., residual area, calculated as 100 ·(AUC0-∞ - AUC0-t) / AUC0-∞.
A total of 40 blood samples were collected as follows:
- Twenty (20) blood samples at pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60 and 72 hours after the administration of givinostat, on Days 1 and 8, for the determination of givinostat
Measured: In the turn of 72 hours after administration of Givinostat
Tmax of Givinostat, Following Single Doses of the Parent Drug
Tmax =The time of occurrence of maximum observed concentration of Givinostat.
A total of 40 blood samples were collected as follows:
- Twenty (20) blood samples at pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60 and 72 hours after the administration of givinostat, on Days 1 and 8, for the determination of Givinostat.
Measured: In the turn of 72 hours after administration of Givinostat
λz of Givinostat, Following Single Doses of the Parent Drug
λz is the apparent first order elimination rate constant associated with the terminal (log-linear) portion of the concentration versus time curve. The parameter is estimated by linear least square regression analysis using the last three (or more) non- zero concentrations.
A total of 40 blood samples were collected as follows:
- Twenty (20) blood samples at pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60 and 72 hours after the administration of givinostat, on Days 1 and 8, for the determination of givinostat
Measured: In the turn of 72 hours after administration of Givinostat
t1/2 of Givinostat, Following Single Doses of the Parent Drug
t1/2 is the apparent terminal elimination half-life, calculated as ln(2)/λz.
A total of 40 blood samples were collected as follows:
- Twenty (20) blood samples at pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60 and 72 hours after the administration of givinostat, on Days 1 and 8, for the determination of Givinostat.
Measured: In the turn of 72 hours after administration of Givinostat
Secondary outcomes (1)
Severity of Treatment Emergent Adverse Events (TEAE)
An AE was considered as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily imply a causal relationship with this treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The period of observation for the collection of medical occurrences extended from the time when the subject gave Informed Consent until the follow-up visit.
Measured: Throughout the study and 10-14 days after the EoS (follow-up visit), i.e. up to day 30-34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start21 Mar 2022
- Primary completion8 May 2022
- Study completion24 May 2022
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 Drug Drug InteractionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Italfarmaco
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marlene Fonseca, MD, Principal investigator, Blueclinical, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845567
- Sponsor's protocol ID
- ITF/2357/55 - PART 2
- Other IDs
- 2021-005756-11
- Status last verified
- Jul 2024
- First submitted
- 26 Apr 2023
- Last updated
- 16 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-center, Study in Healthy Subjects to Investigate the Effect of Oral Clarithromycin on the Pharmacokinetics of Givinostat (PART 2)
- ClinicalTrials.gov ID
- NCT05845567
- Acronym / sponsor ID
- ITF/2357/55 - PART 2
- Conditions
- Drug Drug Interaction
- Keywords
- PK, Pharmacokinetics, Givinostat, Clarythromycin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ItalfarmacoIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 8 May 2022 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Posted 9 Feb 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 assess the potential effect of oral Clarithromycin on the single-dose pharmacokinetics of Givinostat.
Secondary objective:
To assess the safety and tolerability of concomitant administration of Givinostat plus Clarithromycin.
Detailed description
This study was planned as a phase I, open-label, 3-part, fixed-sequence, non-randomized study in healthy male and female subjects. The study (Part 2) aimed at assessing the potential effect of Clarythromycin on the single dose pharmacokynetics of Givinostat.
The total duration of Part 2 was divided as follows:
- Screening: up to 21 days.
- Treatment Period: Days 1 to 11.
- Safety follow-up visit: 12±2 days.
Subjects were confined at site from Day -1 to Day 11. On Days 1 and 8, a single dose of 50 mg Givinostat, as oral suspension, was administered 1 hour after the planned morning time of Clarithromycin administration.
From Day 4 to Day 10, clarithromycin 500 mg film-coated tablets were administered twice a day, in the morning and in the evening.
The following assessments were performed:
- Blood collection for pharmacokinetic analysis on Days 1 to 4 and 8 to 11.
- Vital signs measurements on Days 1 and 4 to 10.
- 12-lead ECG on Days 1, 3, 7 and 8.
- Blood collection for laboratory tests (hematology and biochemistry) on Day 3.
Subjects were discharged in the morning of Day 11 after completing end of study procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Givinostat + Clarithromycin | Experimental | Drug: Givinostat, Drug: ClarithromycinGivinostat and Clarithromycin Days 1 and 8, Givinostat 50 mg as oral suspension was administered as a single dose, 1 hour after Clarithromycin administration. From Day 4 to Day 10, Clarithromycin 500 mg film-coated tablet was administered twice a day. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- A subject was considered eligible for the study if he/she fulfilled all the inclusion criteria:
Key exclusion criteria (35 listed)
- A subject was excluded from the study if he/she fulfilled any of the exclusion criteria:
- At Screening
- Previous use of Givinostat.
- History of anaphylaxis reaction or clinically significant drug hypersensitivity reaction (e.g., angioedema, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, drug-induced hypersensitivity syndrome, druginduced neutropenia).
- Known history of hypersensitivity and/or allergic reactions to Givinostat, histone deacetylases (HDAC) inhibitors or to any excipient in the formulation.
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 |
|---|---|---|
| GivinostatAlso: ITF2357ITF2357 Givinostat 10mg/mL. Dose: 10 mg/mL; Dosage form: oral suspension. | Drug | Givinostat + Clarithromycin |
| ClarithromycinAlso: Klacid®Clarithromycin 500 mg immediate-release oral film-coated tablet (Klacid®) was administered twice a day, in the morning and in the evening. | Drug | Givinostat + Clarithromycin |
Primary outcome
Cmax of Givinostat, Following Single Doses of the Parent Drug
Time frame: In the turn of 72 hours after administration of Givinostat
Maximum observed plasma concentration (Cmax) of givinostat. A total of 40 blood samples were collected as follows: - Twenty (20) blood samples at pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60 and 72 hours after the administration of givinostat, on Days 1 and 8, for the determination of Givinostat.
AUC0-t of Givinostat, Following Single Doses of the Parent Drug
Time frame: In the turn of 72 hours after administration of Givinostat
AUC0-t = area under the curve from time zero to last sampling time with quantifiable concentrations. A total of 40 blood samples were collected as follows: - Twenty (20) blood samples at pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60 and 72 hours after the administration of Givinostat, on Days 1 and 8, for the determination of Givinostat.
AUC0-inf of Givinostat, Following Single Doses of the Parent Drug
Time frame: In the turn of 72 hours after administration of Givinostat
AUC0-inf=Total AUC extrapolated to infinity, calculated as AUC0-t + Clast/λz, where Clast is the last measurable concentration and λz is the apparent terminal elimination rate constant. A total of 40 blood samples were collected as follows: - Twenty (20) blood samples at pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60 and 72 hours after the administration of givinostat, on Days 1 and 8, for the determination of givinostat.
%AUCextrap of Givinostat, Following Single Doses of the Parent Drug
Time frame: In the turn of 72 hours after administration of Givinostat
%AUC0extrap = Percentage of AUC0-∞ due to extrapolation from the time of the last measurable concentration (tlast) to infinity, i.e., residual area, calculated as 100 ·(AUC0-∞ - AUC0-t) / AUC0-∞. A total of 40 blood samples were collected as follows: - Twenty (20) blood samples at pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60 and 72 hours after the administration of givinostat, on Days 1 and 8, for the determination of givinostat
Tmax of Givinostat, Following Single Doses of the Parent Drug
Time frame: In the turn of 72 hours after administration of Givinostat
Tmax =The time of occurrence of maximum observed concentration of Givinostat. A total of 40 blood samples were collected as follows: - Twenty (20) blood samples at pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60 and 72 hours after the administration of givinostat, on Days 1 and 8, for the determination of Givinostat.
λz of Givinostat, Following Single Doses of the Parent Drug
Time frame: In the turn of 72 hours after administration of Givinostat
λz is the apparent first order elimination rate constant associated with the terminal (log-linear) portion of the concentration versus time curve. The parameter is estimated by linear least square regression analysis using the last three (or more) non- zero concentrations. A total of 40 blood samples were collected as follows: - Twenty (20) blood samples at pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60 and 72 hours after the administration of givinostat, on Days 1 and 8, for the determination of givinostat
t1/2 of Givinostat, Following Single Doses of the Parent Drug
Time frame: In the turn of 72 hours after administration of Givinostat
t1/2 is the apparent terminal elimination half-life, calculated as ln(2)/λz. A total of 40 blood samples were collected as follows: - Twenty (20) blood samples at pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60 and 72 hours after the administration of givinostat, on Days 1 and 8, for the determination of Givinostat.
1 secondary outcome
Severity of Treatment Emergent Adverse Events (TEAE)
Time frame: Throughout the study and 10-14 days after the EoS (follow-up visit), i.e. up to day 30-34
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 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.
Marlene Fonseca, MD principal investigator
Blueclinical, Ltd.
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 Givinostat and Clarithromycin in people with Drug Drug Interaction, run by Italfarmaco at 1 site in Portugal.
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 23 inclusion and 35 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 16 Aug 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 Portugal. 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 9 Feb 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?
Cmax of Givinostat, Following Single Doses of the Parent Drug (time frame: In the turn of 72 hours after administration of Givinostat). The study lists 7 primary outcomes in all. 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 16 Aug 2024.