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Hepatic ImpairmentPhase 1/2NCT05009680

A Single and Repeat Dose Trial in Participants With Hepatic Impairment

A Phase 1/2 study testing GB1211 in people with Hepatic Impairment, run by Galecto Biotech AB at 4 sites in Bulgaria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a a single (open-label) and repeat dose (randomised, placebo controlled) trial to assess the safety, tolerability and pharmacokinetics of GB1211 (Gal-3 inhibitor) in participants with hepatic impairment (Child Pugh B and Child Pugh C) Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Hepatic Impairment
What is being tested?
GB1211
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
4 sitesBulgaria
Study dates
9 Sep 2021to 4 Jul 2023
Phase
Phase 1/2
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Main Inclusion Criteria:
  • Males or females, of any race, ≥ 18 and ≤ 75 years of age at enrolment
  • Body mass index (BMI) of ≥ 18-40 kg/m2
  • Participants with hepatic impairment:
  • PART 1 and PART 2: Moderate hepatic impairment, as defined by the Child-Pugh score (Child-Pugh B) [1] who exhibit physical signs consistent with stable hepatic impairment and free of significant medical disorders unrelated to their hepatic disorder and are on stable concomitant medication for 2 weeks prior to and for the duration of this study
  • PART 3: Severe hepatic impairment as defined by the Child-Pugh score (Child Pugh C) who exhibit physical signs consistent with stable hepatic impairment and free of significant medical disorders unrelated to their hepatic disorder and are on stable concomitant medication for 2 weeks prior to and for the duration of this study
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  • Healthy participants (controls) in PART 1 and PART 3:
  • Healthy as determined by the investigator, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac assessment
  • Match at least one of the participants with moderate or severe hepatic impairment with respect to gender, age (±10 years), and body mass index (BMI) ± 15% (ensure every participant with hepatic impairment has at least 1 matched control)
  • Women of non-childbearing potential defined as permanently sterile or postmenopausal
  • Males will agree to use contraception throughout the study and until 90-days after the Follow-up visit
  • Male participants must agree to refrain from sperm donation from the date of Randomisation (Day 1) until 90 days after the Follow up visit
  • Able to comprehend and willing to sign an ICF and to abide by the study restrictions

Who cannot join

  • All parts and all groups (control healthy volunteers and hepatic impairment)
  • History of an organ transplant, including a remote history of bone marrow transplant
  • History of febrile illness within 7 days prior to the first dose of study drug or participants with evidence of active infection
  • Use of any oral glucocorticoids at any dose within 30 days prior to Screening and until study completion
  • Have previously completed or withdrawn from a study investigating GB1211 and have previously received the investigational product
  • Participant who, in the opinion of the Investigator (or Designee), should not participate in this study
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  • Vulnerable/institutionalised patients
  • Patients related to Principal Investigator (PI)/site staff
  • If female, the participant is of child-bearing potential
  • Participation in a clinical study involving administration of an investigational agent e.g. new chemical entity or a biological product in the past 90 days (or 5 multiples of half-life, whichever is longer) prior to dosing.
  • Medical history of cardiac disease and/or clinically significant ECG abnormalities. An abnormal ECG is defined as PR > 220 msec, QRS complex >120 msec, QTcF > 450 msec (males) and > 470msec (females), or any other morphological changes, other than nonspecific T-wave changes
  • Donation or loss of ≥ 400 mL blood or plasma less than 4 weeks prior to screening, or longer if required by local regulations
  • Positive HIV test
  • Have received live vaccine(s) within 30 days prior to Screening or who will require a vaccine(s) and until study completion
  • Use of any medications/products that may inhibit biliary excretion, e.g. bile salt chelators, mycophenolic acid, warfarin, and digoxin, within 30 days prior to Screening and until study completion
  • Use of any medications/products that may inhibit renal excretion; e.g. cimetidine, pyrimethamine, dolutegravir, probenecid, within 30 days prior to Screening and until study completion
  • Use of any medications/products that are known inhibitors of P-gp (e.g. clarithromycin, fostamatinib, quinidine, quinine) and inducers of P-gp (e.g. carbmazepine, rifampin, St. John's wort) within 30 days prior to Screening and until study completion
  • Additional exclusion criteria for matched healthy control subjects:
  • Use of any prescription or non-prescription medication (OTC), herbal medication, dietary supplements or vitamins during 30 days prior to dosing. Acetaminophen is acceptable
  • History or presence of liver disease or liver injury as indicated by an abnormal liver function profile such as AST, ALT, alkaline phosphatase, or serum bilirubin
  • A positive Hepatitis C test or a positive Hepatitis B surface antigen (HBsAg)
  • Estimated glomerular filtration rate (eGFR) < 80 mL/[min*1.73 m²] (estimated using the Modification of Diet in Renal Disease [MDRD] equation) at Screening
  • Additional exclusion criteria for hepatic impaired subjects:
  • Participants meeting any of the following exclusion criteria are not to be enrolled in the study/randomised to treatment:
  • History of any known serious disease (such as cancer, except skin basal cell carcinomas, major infection, clinically significant gastrointestinal disorder, major autoimmune disease) or other disease which in the Investigator's opinion would exclude the patient from the study
  • Estimated glomerular filtration rate (eGFR) < 40 mL/[min*1.73 m²] (estimated using the [MDRD] equation) at Screening
  • Use of any hepatotoxic drug (e.g. methotrexate, isoniazid, amiodarone) within 30 days of Screening and until study completion
  • Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's Wort, or other putatively hepatoprotective herbal remedies such as milk thistle derivatives, within 30 days prior to dosing, unless deemed acceptable by the Investigator (or Designee). Milk thistle derivates or other hepatoprotective herbal remedies are allowed if stable dose is administered 30 days before dosing
  • Use or intend to use slow release medications/products considered to still be active within 14 days prior to Randomisation, unless deemed acceptable by the Investigator (or Designee)

Trial locations and contacts

4 sites in 1 country.

Bulgaria4 sites

  • COAMC Medical

    Sofia, 1000

  • Gastroenterology Clinic, Lozenets district

    Sofia, 1407

  • Diagnostic-Advisory center 'ALEKSANDROVSKA" Ltd

    Sofia, 1431

  • University Multiprofile Hospital, Clinic of gastroenterology

    Sofia, Оborishte District, 1527

Other trials in Bulgaria

About this study

Official title: GULLIVER-2 - A Single (Open-label) and Repeat Dose (Randomised, Placebo-controlled) Trial to Assess the Safety, Tolerability and Pharmacokinetics of GB1211 in Participants With Hepatic Impairment (Child Pugh B & C)

This study is a a single (open-label) and repeat dose (randomised, placebo controlled) trial to assess the safety, tolerability and pharmacokinetics of GB1211 (Gal-3 inhibitor) in participants with hepatic impairment (Child Pugh B and Child Pugh C)

Read the detailed description

PART 1 A single dose, open-label safety and PK study of GB1211 administered to participants with moderate hepatic impairment (Child Pugh B) and to matched healthy participants (controls).

PART 2 A randomised, double-blind, placebo-controlled study in participants with moderate hepatic impairment (Child Pugh B). GB1211 or placebo will be administered daily for 12 weeks.

PART 3 A single dose, open-label safety and PK study of GB1211 administered to participants with severe hepatic impairment (Child Pugh C) and to healthy participants (controls).

Being tested
GB1211, Placebo
Keywords
Child Pugh B, Child Pugh C, Liver Cirrhosis, Galectin 3 Inhibitor
Medical subject headings
Liver Cirrhosis

What participants receive

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

  • GB1211Drug

    GB1211 is a galectin-3 inhibitor an orally available small molecule anti-fibrotic. It is administered orally twice a day

  • PlaceboDrug

    Placebo is administered orally twice a day

Study groups in NCT05009680
Study groupRoleWhat they receive
Part 1 GB1211, Single Dose (Child Pugh B)ExperimentalGB1211 is a galectin-3 inhibitor an orally available small molecule anti-fibrotic. It is administered orally twice a day.
Receives: Drug: GB1211
Part 1 GB1211 Healthy Matched Participants, Single DoseExperimentalGB1211 is a galectin-3 inhibitor an orally available small molecule anti-fibrotic. It is administered orally twice a day.
Receives: Drug: GB1211
Part 2 GB1211 Multiple Dose, Twice a day (Child Pugh B)ExperimentalGB1211 is a galectin-3 inhibitor an orally available small molecule anti-fibrotic. It is administered orally twice a day.
Receives: Drug: GB1211
Part 2 Placebo, Twice a day (Child Pugh B)Placebo comparatorPlacebo is administered twice daily
Receives: Drug: Placebo
Part 1 GB1211, Single Dose (Child Pugh C)ExperimentalPart 1 GB1211 Healthy Matched Participants, Single Dose
Receives: Drug: GB1211
Part 3 GB1211 Healthy Matched Participants, Single DoseExperimentalPart 1 GB1211 Healthy Matched Participants, Single Dose
Receives: Drug: GB1211

What is being measured

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

  1. Parts 1 Safety and Tolerability of GB1211

    Incidence and severity of adverse events as reported by investigators

    Measured: 11 Days

  2. Parts 2 Safety and Tolerability of GB1211

    Incidence and severity of adverse events as reported by investigators

    Measured: 12 Weeks

  3. Parts 3 Safety and Tolerability of GB1211

    Incidence and severity of adverse events as reported by investigators

    Measured: 11 Days

Secondary outcomes (3)

  1. Part 2 Collagen Production and Breakdown Biomarkers

    Assessment of liver fibrosis using pro-C3, CK18 and PAI-1 Biomarkers

    Measured: 12 Weeks

  2. Part 2 Changes on liver and spleen stiffness

    Assessment of liver and spleen stiffness measured by vibration control transient elastography

    Measured: 12 Weeks

  3. Part 2 Changes in Liver Functional Capacity

    Assessment of Liver functional Capacity measured by 13C methacetin breath test

    Measured: 12 Weeks

Timeline

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

  1. First posted17 Aug 2021
  2. Study start9 Sep 2021
  3. Primary completion18 Jul 2022
  4. Study completion4 Jul 2023 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parts 1 \& 3 Open Label, Single Dose Part 2 Randomised to either GB1211 or Placebo
Masking
Single blind
Who is masked
Participant
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05009680
Sponsor's protocol ID
GULLIVER-2
Status last verified
Feb 2023
First submitted
27 Jul 2021
Last updated
11 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aslanis V, Gray M, Slack RJ, Zetterberg FR, Tonev D, Phung D, Smith B, Jacoby B, Schambye H, Krastev Z, Ungell AL, Lindmark B. Single-Dose Pharmacokinetics and Safety of the Oral Galectin-3 Inhibitor, Selvigaltin (GB1211), in Participants with Hepatic Impairment. Clin Drug Investig. 2024 Oct;44(10):773-787. doi: 10.1007/s40261-024-01395-7. Epub 2024 Oct 2.

    PubMed 39358661

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GB1211 in people with Hepatic Impairment, run by Galecto Biotech AB at 4 sites in Bulgaria.

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 13 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Bulgaria. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Parts 1 Safety and Tolerability of GB1211 (time frame: 11 Days). The study lists 3 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 NCT05009680, which also lists 1 linked publication.

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 11 May 2023.

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