Non-Alcoholic Fatty Liver DiseasePhase 1NCT05203367
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BAR 502 in Healthy Subjects
A Phase 1 study testing BAR502 in people with Non-Alcoholic Fatty Liver Disease, run by BAR Pharmaceuticals s.r.l. at 1 site in Portugal.
Trial summary
This is a prospective, single-center, randomized, double-blind, placebo-controlled, single-ascending dose (SAD) phase 1 study to evaluate the safety and tolerability of single-ascending doses of BAR 502 in healthy male and female subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- BAR502
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 sitePortugal
- Study dates
- 25 Nov 2022to 30 Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
- Ability to communicate well with the investigator, and to understand and comply with the study requirements.
- Healthy male or female subject aged between 18 and 55 years (inclusive) at Screening.
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at Screening.
- Systolic blood pressure (SBP) 90-140 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on same arm after ≥5 min in the seated position, at Screening.
- Estimated glomerular filtration rate calculated using the Cockcroft-Gault equation and normalized to an average surface area of 1.73 m2 ≥ 90 mL/min at Screening.
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- If woman, she meets one of the following criteria:
- is of non-childbearing potential; or
- is of childbearing potential and agrees to use an accepted non-hormonal or hormonal contraceptive method.
- If man, he is infertile, vasectomized (i.e. who has received medical assessment of the surgical success) or agrees to abstain from or to use a condom during heterosexual intercourse with a woman of childbearing potential or a pregnant woman, and agrees not to donate sperm, from investigational product administration until at least 90 days after the investigational product administration. In addition, the subject must ensure that his female partner of childbearing potential agrees to consistently and correctly use one of the acceptable contraceptive methods mentioned above, for the same period of time.
Who cannot join
- At screening:
- Previous exposure to BAR 502.
- Known hypersensitivity to BAR 502, or any of its excipients.
- Clinically relevant findings on physical examination.
- Clinically relevant abnormalities on 12-lead ECG, measured after 5 min in a supine position.
- Clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry, and urinalysis).
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- QTcF > 450 ms in males and > 470 ms in females.
- Medical history and/or clinical or laboratory evidence of liver or hepatobiliary disease or liver injury as indicated by serum alanine aminotransferase (ALT), AST, gamma-glutamyl transferase (GGT), ALP or total bilirubin levels exceeding the upper limit of normal (ULN).
- International Normalized Ratio (INR) > 1.2.
- Any medical condition, acute, ongoing, recurrent or chronic, that presents a potential risk to the participant and/or that may compromise the objectives of the study.
- History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the distribution, metabolism, or excretion of the investigational product.
- History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to Screening.
- Previous clinically relevant history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
- Veins unsuitable for intravenous puncture on either arm (e.g., veins that are difficult to locate, access, or puncture, veins with a tendency to rupture during or after puncture).
- Participation in a clinical study involving investigational product administration within 3 months prior to Screening or in more than 2 clinical studies within 1 year prior to Screening.
- Excessive methylxanthines consumption, defined as ≥ 800 mg per day.
- Nicotine intake (e.g., smoking, nicotine patch, nicotine chewing gum, or electronic cigarettes) within 3 months prior to Screening and inability to refrain from nicotine intake from Screening up to End-of-Study (EOS).
- Loss of 250 mL or more of blood within 3 months prior to Screening.
- Positive hepatitis B surface antigen (HBsAg) and/or hepatitis C virus antibodies.
- Positive human immunodeficiency virus (HIV1 and HIV2) antibodies.
- Positive results in urine drugs-of-abuse, cotinine or ethanol tests.
- If woman, she is breastfeeding.
- Positive result in serum pregnancy test.
- Any other circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol or may render the subject unsuitable for the study.
- At admission to treatment period:
- Positive or inconclusive SARS-CoV-2 test result using polymerase chain reaction (PCR) technology prior to Admission to the clinical site.
- Any recent disease or condition or treatment that, according to the Investigator, would put the subject at undue risk due to study participation or occurred at a timeframe in which may interfere with the study outcomes.
- Clinically relevant findings on physical examination.
- Clinically relevant abnormalities on 12-lead ECG, measured after 5 min in a supine position.
- Clinically relevant findings in clinical laboratory tests.
- Use of prescription or nonprescription medicinal products, including vitamins, food supplements, herbal supplements (including St John's Wort), within 3 weeks prior to study treatment administration, unless in the Investigator's opinion the medication does not interfere with the pharmacokinetics of study drug or compromise subject safety.
- Consumption of Seville oranges, pomelo, pomegranate, starfruit or grapefruit products (fresh, canned, or frozen) since Screening.
- Positive result in urine drugs-of-abuse, cotinine or ethanol tests.
- Positive result in urine pregnancy test.
- Any other condition that the investigator considers to render the subject unsuitable for the treatment period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses of BAR 502 in Healthy Subjects
This is a prospective, single-center, randomized, double-blind, placebo-controlled, single-ascending dose (SAD) phase 1 study to evaluate the safety and tolerability of single-ascending doses of BAR 502 in healthy male and female subjects.
Read the detailed description
This clinical trial will be the first-in-Human (FiH) study of BAR 502.
This study is planned to investigate up to 4 dose levels of BAR 502. Each dose level will consist of 8 healthy male and female subjects (ratio 1:1, male: female) to have 6 subjects being administered BAR 502 and 2 subjects being administered placebo (ratio 3:1, active: placebo).
The study is designed to meet the following objectives:
- Primary:
- To evaluate the safety and tolerability of single-ascending doses of BAR 502 in healthy male and female subjects.
- Secondary:
- To investigate the pharmacokinetics (PK) of single-ascending doses of BAR 502 in healthy male and female subjects;
- To investigate the pharmacodynamics (PD) of single-ascending doses of BAR 502 in healthy male and female subjects.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- BAR502, Placebo
- Keywords
- Non-alcoholic fatty liver disease, healthy, BAR 502
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAR502Drug
Single oral doses of BAR 502/placebo will be administered as film-coated tablets, in the morning of Day 1, with 240 mL of water, after an overnight fasting of at least 8 hours.
BAR 502 film-coated tablets are available at dose strengths of 10, 50 and 150 mg. A maximum of 4 dose levels are pre-planned (10 mg, 50 mg, 150 mg, 300 mg).
PlaceboDrug
Matching BAR 502 placebo film-coated tablets will be given to 2 out of 8 subjects in each cohort using the same regimen as outlined for the active study treatment
| Study group | Role | What they receive |
|---|---|---|
| BAR 502 | Experimental | Each subject will receive an oral single-dose of BAR 502. Receives: Drug: BAR502 |
| Placebo | Placebo comparator | Each subject will receive an oral single-dose of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Safety will be evaluated through the assessment of adverse events
Measured: Through study completion, an average of 2 months
Assessment of physical examination
Safety will be evaluated through the assessment of physical examination, which will include: general appearance; skin; head and neck; thorax and abdomen; pulmonary auscultation; cardiac auscultation; abdomen palpation; limbs.
Measured: At screening (Day -21 to Day -3 for male and female subjects of non-childbearing potential, Day -28 to Day -7 for female subjects of childbearing potential) and end of study ( Day 8)
Assessment of 12-lead electrocardiogram
Safety will be evaluated through the assessment of 12-lead ECG. The following variables are to be collected on the eCRF: HR (bpm), and the intervals PR (ms), QRS (ms), QT (ms), QTcB (ms) and QTcF (ms).
Measured: At screening (Day -21 to Day -3 for male and female subjects of non-childbearing potential, Day -28 to Day -7 for female subjects of childbearing potential), admission (Day-1), and from day 1 to day 4 of the study
Change from baseline at each time point of measurement in supine blood pressure (both systolic and diastolic)
Safety will be evaluated through the assessment of vital signs (systolic and diastolic blood pressure)
Measured: At screening (Day -21 to Day -3 for male and female subjects of non-childbearing potential, Day -28 to Day -7 for female subjects of childbearing potential), admission (Day -1), from Day 1 to Day 4 of the study, and at end of study (at Day 8).
Change from baseline at each time point of measurement in pulse rate
Safety will be evaluated through the assessment of vital signs
Measured: At screening (Day -21 to Day -3 for male and female subjects of non-childbearing potential, Day -28 to Day -7 for female subjects of childbearing potential), admission (Day -1), from day 1 to day 4 of the study, and at end of study (at Day 8)..
Secondary outcomes (15)
Maximum concentration (Cmax)
Determination of BAR 502 concentrations in plasma, to investigate the pharmacokinetics
Measured: Within 1 hour prior to treatment administration and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 74 hours after treatment administration.
Time of occurrence of Cmax (Tmax)
Determination of BAR 502 concentrations in plasma, to investigate the pharmacokinetics
Measured: Within 1 hour prior to treatment administration and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 74 hours after treatment administration.
Area under the plasma concentration-time curve (AUC) from time zero to last sampling time with quantifiable concentrations (AUC0-t);
Determination of BAR 502 concentrations in plasma, to investigate the pharmacokinetics
Measured: Within 1 hour prior to treatment administration and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 74 hours after treatment administration.
AUC extrapolated to infinity
Determination of BAR 502 concentrations in plasma, to investigate the pharmacokinetics
Measured: Within 1 hour prior to treatment administration and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 74 hours after treatment administration.
Apparent terminal elimination rate constant (λz); and apparent terminal elimination half-life (t1/2)
Determination of BAR 502 concentrations in plasma to investigate the pharmacokinetics
Measured: Within 1 hour prior to treatment administration and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 74 hours after treatment administration.
Cumulative amount of drug excreted in urine (AmtCUM)
Determination of BAR 502 concentrations in urine to investigate the pharmacokinetics
Measured: From treatment administration to day 4 of the study
Area under the urine excretion curve (AUR) from time zero to last observed concentration (AURClast)
Determination of BAR 502 concentrations in urine to investigate the pharmacokinetics
Measured: From treatment administration to day 4 of the study
Maximum rate of urinary excretion (Rmax)
Determination of BAR 502 concentrations in urine to investigate the pharmacokinetics
Measured: From treatment administration to day 4 of the study
Percentage of drug recovered in urine (REC%)
Determination of BAR 502 concentrations in urine to investigate the pharmacokinetics
Measured: From treatment administration to day 4 of the study
Time to Rmax (tumax)
Determination of BAR 502 concentrations in urine to investigate the pharmacokinetics
Measured: From treatment administration to day 4 of the study
Renal clearance (CLR)
Determination of BAR 502 concentrations in urine to investigate the pharmacokinetics
Measured: From treatment administration to day 4 of the study
Serum concentrations of total bile acids over time up to 24 hours post-dose
To investigate the pharmacodynamics
Measured: At admission, within 1 hour prior to study treatment administration, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 16 and 24 hours after treatment administration.
Serum concentrations of FGF19 over time up to 24 hours post-dose.
To investigate the pharmacodynamics (biomarkers of Farnesoid X Receptor (FXR) target engagement)
Measured: At admission, within 1 hour prior to study treatment administration, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 16 and 24 hours after treatment administration
Serum concentrations of C4 over time up to 24 hours post-dose.
To investigate the pharmacodynamics (biomarkers of Farnesoid X Receptor (FXR) target engagement)
Measured: At admission, within 1 hour prior to study treatment administration, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 16 and 24 hours after treatment administration
Serum concentrations of GLP-1 over time up to 24 hours post-dose.
To investigate the pharmacodynamics (marker of G protein-coupled bile acid-activated receptor 1 (GPBAR1) activation)
Measured: At admission, within 1 hour prior to study treatment administration, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 16 and 24 hours after treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start25 Nov 2022 (estimated)
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Why it stopped: Update development program
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A maximum of 4 BAR 502 dose levels are preplanned to be investigated in separate sequential cohorts. Each of these cohorts will consist of 8 healthy male and female subjects (3 subjects of either sex on active treatment, 1 of either sex on placebo). Each subject will participate in only one cohort.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BAR Pharmaceuticals s.r.l.
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203367
- Sponsor's protocol ID
- BLCL-BAR-502-101
- Status last verified
- Jun 2024
- First submitted
- 4 Dec 2021
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses of BAR 502 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05203367
- Acronym / sponsor ID
- BLCL-BAR-502-101
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- Non-alcoholic fatty liver disease, healthy, BAR 502
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Update development program
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BAR Pharmaceuticals s.r.l.Research network
- Study start
- 25 Nov 2022 (estimated)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single-center, randomized, double-blind, placebo-controlled, single-ascending dose (SAD) phase 1 study to evaluate the safety and tolerability of single-ascending doses of BAR 502 in healthy male and female subjects.
Detailed description
This clinical trial will be the first-in-Human (FiH) study of BAR 502.
This study is planned to investigate up to 4 dose levels of BAR 502. Each dose level will consist of 8 healthy male and female subjects (ratio 1:1, male: female) to have 6 subjects being administered BAR 502 and 2 subjects being administered placebo (ratio 3:1, active: placebo).
The study is designed to meet the following objectives:
- Primary:
- To evaluate the safety and tolerability of single-ascending doses of BAR 502 in healthy male and female subjects.
- Secondary:
- To investigate the pharmacokinetics (PK) of single-ascending doses of BAR 502 in healthy male and female subjects;
- To investigate the pharmacodynamics (PD) of single-ascending doses of BAR 502 in healthy male and female subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A maximum of 4 BAR 502 dose levels are preplanned to be investigated in separate sequential cohorts. Each of these cohorts will consist of 8 healthy male and female subjects (3 subjects of either sex on active treatment, 1 of either sex on placebo). Each subject will participate in only one cohort.
| Arm | Type | Receives |
|---|---|---|
| BAR 502 | Experimental | Drug: BAR502Each subject will receive an oral single-dose of BAR 502. |
| Placebo | Placebo comparator | Drug: PlaceboEach subject will receive an oral single-dose of placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
- Ability to communicate well with the investigator, and to understand and comply with the study requirements.
- Healthy male or female subject aged between 18 and 55 years (inclusive) at Screening.
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at Screening.
- Systolic blood pressure (SBP) 90-140 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on same arm after ≥5 min in the seated position, at Screening.
Key exclusion criteria (35 listed)
- At screening:
- Previous exposure to BAR 502.
- Known hypersensitivity to BAR 502, or any of its excipients.
- Clinically relevant findings on physical examination.
- Clinically relevant abnormalities on 12-lead ECG, measured after 5 min in a supine position.
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 |
|---|---|---|
| BAR502Single oral doses of BAR 502/placebo will be administered as film-coated tablets, in the morning of Day 1, with 240 mL of water, after an overnight fasting of at least 8 hours. BAR 502 film-coated tablets are available at dose strengths of 10, 50 and 150 mg. A maximum of 4 dose levels are pre-planned (10 mg, 50 mg, 150 mg, 300 mg). | Drug | BAR 502 |
| PlaceboMatching BAR 502 placebo film-coated tablets will be given to 2 out of 8 subjects in each cohort using the same regimen as outlined for the active study treatment | Drug | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Through study completion, an average of 2 months
Safety will be evaluated through the assessment of adverse events
Assessment of physical examination
Time frame: At screening (Day -21 to Day -3 for male and female subjects of non-childbearing potential, Day -28 to Day -7 for female subjects of childbearing potential) and end of study ( Day 8)
Safety will be evaluated through the assessment of physical examination, which will include: general appearance; skin; head and neck; thorax and abdomen; pulmonary auscultation; cardiac auscultation; abdomen palpation; limbs.
Assessment of 12-lead electrocardiogram
Time frame: At screening (Day -21 to Day -3 for male and female subjects of non-childbearing potential, Day -28 to Day -7 for female subjects of childbearing potential), admission (Day-1), and from day 1 to day 4 of the study
Safety will be evaluated through the assessment of 12-lead ECG. The following variables are to be collected on the eCRF: HR (bpm), and the intervals PR (ms), QRS (ms), QT (ms), QTcB (ms) and QTcF (ms).
Change from baseline at each time point of measurement in supine blood pressure (both systolic and diastolic)
Time frame: At screening (Day -21 to Day -3 for male and female subjects of non-childbearing potential, Day -28 to Day -7 for female subjects of childbearing potential), admission (Day -1), from Day 1 to Day 4 of the study, and at end of study (at Day 8).
Safety will be evaluated through the assessment of vital signs (systolic and diastolic blood pressure)
Change from baseline at each time point of measurement in pulse rate
Time frame: At screening (Day -21 to Day -3 for male and female subjects of non-childbearing potential, Day -28 to Day -7 for female subjects of childbearing potential), admission (Day -1), from day 1 to day 4 of the study, and at end of study (at Day 8)..
Safety will be evaluated through the assessment of vital signs
15 secondary outcomes
Maximum concentration (Cmax)
Time frame: Within 1 hour prior to treatment administration and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 74 hours after treatment administration.
Time of occurrence of Cmax (Tmax)
Time frame: Within 1 hour prior to treatment administration and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 74 hours after treatment administration.
Area under the plasma concentration-time curve (AUC) from time zero to last sampling time with quantifiable concentrations (AUC0-t);
Time frame: Within 1 hour prior to treatment administration and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 74 hours after treatment administration.
AUC extrapolated to infinity
Time frame: Within 1 hour prior to treatment administration and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 74 hours after treatment administration.
Apparent terminal elimination rate constant (λz); and apparent terminal elimination half-life (t1/2)
Time frame: Within 1 hour prior to treatment administration and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 74 hours after treatment administration.
Cumulative amount of drug excreted in urine (AmtCUM)
Time frame: From treatment administration to day 4 of the study
Area under the urine excretion curve (AUR) from time zero to last observed concentration (AURClast)
Time frame: From treatment administration to day 4 of the study
Maximum rate of urinary excretion (Rmax)
Time frame: From treatment administration to day 4 of the study
Percentage of drug recovered in urine (REC%)
Time frame: From treatment administration to day 4 of the study
Time to Rmax (tumax)
Time frame: From treatment administration to day 4 of the study
Renal clearance (CLR)
Time frame: From treatment administration to day 4 of the study
Serum concentrations of total bile acids over time up to 24 hours post-dose
Time frame: At admission, within 1 hour prior to study treatment administration, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 16 and 24 hours after treatment administration.
Serum concentrations of FGF19 over time up to 24 hours post-dose.
Time frame: At admission, within 1 hour prior to study treatment administration, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 16 and 24 hours after treatment administration
Serum concentrations of C4 over time up to 24 hours post-dose.
Time frame: At admission, within 1 hour prior to study treatment administration, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 16 and 24 hours after treatment administration
Serum concentrations of GLP-1 over time up to 24 hours post-dose.
Time frame: At admission, within 1 hour prior to study treatment administration, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 16 and 24 hours after treatment administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 BAR502 in people with Non-Alcoholic Fatty Liver Disease, run by BAR Pharmaceuticals s.r.l. 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 10 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: withdrawn, as of the sponsor's last update on 20 Jun 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incidence of Treatment-Emergent Adverse Events (time frame: Through study completion, an average of 2 months). The study lists 5 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 20 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.