Clinical Trials Register

Summary
EudraCT Number:	2021-001235-12
Sponsor's Protocol Code Number:	GULLIVER-2
National Competent Authority:	Bulgarian Drug Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-06-18
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Bulgarian Drug Agency

A.2

EudraCT number

2021-001235-12

A.3

Full title of the trial

GULLIVER-2 - 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)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study to assess the safety, tolerability and pharmacokinetics of GB1211 in participants with hepatic impairment.

A.4.1

Sponsor's protocol code number

GULLIVER-2

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Galecto Biotech AB
B.1.3.4	Country	Denmark
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Galecto Biotech AB
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Galecto Biotech AB
B.5.2	Functional name of contact point	Chief Medical Officer
B.5.3	Address:
B.5.3.1	Street Address	Cobis Science Park, Ole Maaloes Vej 3
B.5.3.2	Town/ city	Copenhagen
B.5.3.3	Post code	DK-2200
B.5.3.4	Country	Denmark
B.5.6	E-mail	Clinicaltrials@galecto.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	GB1211
D.3.2	Product code	GB1211
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GB1211
D.3.9.2	Current sponsor code	GB1211
D.3.9.3	Other descriptive name	GB1211
D.3.9.4	EV Substance Code	SUB207922
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Healthy subjects (for study Parts 1 and 3) and patients with hepatic impairment (Child Pugh B and Child Pugh C) (cirrhosis)

E.1.1.1

Medical condition in easily understood language

Patients with moderate hepatic impairment (Child Pugh B) or severe hepatic impairment (Child Pugh C) (cirrhosis, damaged liver functions).

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	22.1
E.1.2	Level	LLT
E.1.2	Classification code	10052254
E.1.2	Term	Hepatic impairment
E.1.2	System Organ Class	100000004871

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Primary objective (Part 1, 2 and 3):
To assess the effect of hepatic impairment on the safety, tolerability and pharmacokinetics of GB1211 in participants with moderate or severe hepatic impairment.

E.2.2

Secondary objectives of the trial

Secondary objectives (Part 2):
To assess the effect of GB1211 on liver and spleen stiffness and on hepatic function in participants with moderate hepatic impairment

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Males or females, of any race, ≥ 18 and ≤ 75 years of age at enrolment
2.Body mass index (BMI) of ≥ 18–40 kg/m2
3.Participants with hepatic impairment:
a.PART 1 and PART 2: Moderate hepatic impairment, as defined by the Child–Pugh score (Child-Pugh B) 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 and for the duration of this study.
b.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 and for the duration of this study.
4.Healthy participants (controls) in PART 1 and PART 3:
a.Healthy as determined by the investigator, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac assessment
b.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.)
5.Women of non-childbearing potential defined as permanently sterile or postmenopausal
6.Males will agree to use contraception throughout the study and until 90-days after the Follow-up visit
7.Male participants must agree to refrain from sperm donation from the date of Randomisation (Day 1) until 90 days after the Follow up visit
8.At screening, and baseline, vital signs which are within the following ranges:
• Systolic blood pressure: ≥ 90 and ≤ 150 mm Hg
• Diastolic blood pressure: ≥ 50 and ≤ 95 mm Hg
• Pulse rate: ≥ 40 and ≤ 100 Beats Per Minute (BPM)
9.Able to comprehend and willing to sign an ICF and to abide by the study restrictions

E.4

Principal exclusion criteria

All parts and all groups (control healthy volunteers and hepatic impairment)
1.History of an organ transplant, including a remote history of bone marrow transplant.
2.History of febrile illness within 7 days prior to the first dose of study drug or participants with evidence of active infection.
3.Use of any oral glucocorticoids at any dose within 30 days prior to Screening and until study completion .
4.Have previously completed or withdrawn from a study investigating GB1211 and have previously received the investigational product. (applicable for Part 1 and Part 3 only)
5.Participant who, in the opinion of the Investigator (or Designee), should not participate in this study.
6.Vulnerable/institutionalised patients.
7.Patients related to Principal Investigator (PI)/site staff.
8.If female, the participant is of child-bearing potential.
9.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.
10.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.
11.Donation or loss of ≥ 400 mL blood or plasma less than 4 weeks prior to screening, or longer if required by local regulations.
12.Positive HIV test.
13.Have received live vaccine(s) within 30 days prior to Screening or who will require a vaccine(s) and until study completion.
14.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.
15.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.
16.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:
17.Use of any prescription or non-prescription medication (OTC), herbal medication, dietary supplements or vitamins during 30 days prior to dosing.Acetaminophen is acceptable.
18.History or presence of liver disease or liver injury as indicated by an abnormal liver function profile such as AST, ALT, alkaline phosphate, or serum bilirubin
19.A positive Hepatitis C test or a positive Hepatitis B surface antigen (HBsAg)
20.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:
21.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
22.Estimated glomerular filtration rate (eGFR) < 40 mL/[min*1.73 m²] (estimated using the MDRD equation) at Screening
23.Use of any hepatotoxic drug (e.g. methotrexate, isoniazid, amiodarone) within 30 days of Screening and until study completion.
24.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
25.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)

E.5 End points

E.5.1

Primary end point(s)

•AEs, SAEs, clinical laboratory investigations, haematology and urinalysis, vital signs, physical examination, and ECGs;
•Plasma concentrations and pharmacokinetic parameters of unbound and total GB1211
•Urine concentrations and pharmacokinetic parameters of GB1211

E.5.1.1

Timepoint(s) of evaluation of this end point

Please refer to the schedule of assessments within the protocol.

E.5.2

Secondary end point(s)

Applicable only to Part 2 of the study:
•Maximum liver function capacity assessment as measured by liver maximum capacity (LiMAx) test (a dynamic liver function test based on the metabolism of 13C-methacetin by the liver-specific cytochrome P450 1A2 system);
•FibroScan: Liver and spleen stiffness measured in kPa by transient elastography

E.5.2.1

Timepoint(s) of evaluation of this end point

Please refer to the schedule of assessments within the protocol.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

Phase Ib/IIa study design

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Parts 1 and 3 of the study are open-labeled, single dose

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-07-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-07-20

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-07-04

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