An Open-label, Randomized, Three-period, Crossover Study to compare the Pharmacokinetics of GB1211 upon dosing a capsule under fasting condition and a tablet under fasting and fed conditions in healthy volunteers.

2022-502200-67-00 Protocol GB1211-CPH-005 Human pharmacology (Phase I) - Other Ended

Start 27 Dec 2022 · End 10 Apr 2023 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol GB1211-CPH-005

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ended
Participants planned 12
Countries 1
Sites 1

Non-small Cell Lung Cancer

To compare the PK of a tablet formulation relative to a capsule formulation of GB1211 under fasting conditions in healthy volunteers. To assess the effect of food on the pharmacokinetics (PK) of GB1211, administered as a tablet formulation.

Key facts

Sponsor
Galecto Biotech AB
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Neoplasms [C04]
Trial duration
27 Dec 2022 → 10 Apr 2023
Decision date (initial)
2022-12-20
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Galecto Biotech AB

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic

To compare the PK of a tablet formulation relative to a capsule formulation of GB1211 under fasting conditions in healthy volunteers.
To assess the effect of food on the pharmacokinetics (PK) of GB1211, administered as a tablet formulation.

Secondary objectives 1

  1. To assess the safety and tolerability of GB1211 after intake of a capsule in the absence of food and a tablet in the absence and presence of food.

Conditions and MedDRA coding

Non-small Cell Lung Cancer

VersionLevelCodeTermSystem organ class
20.0 LLT 10016648 Fibrosis liver 10019805
21.1 PT 10061873 Non-small cell lung cancer 100000004864

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Subjects must provide written informed consent prior to any Screening procedures being performed.
  2. Male and female subjects 18-55 years of age (inclusive) on the day of signing the informed consent
  3. Subjects deemed in good physical health by the Investigator, as determined by no clinically significant findings from medical history, laboratory safety tests (serology, hematology, biochemistry and urinalysis), physical examination, vital signs, and ECG
  4. Women of child-bearing potential must agree not to attempt to become pregnant or donate ova, and to use a highly effective form of hormonal or non-hormonal birth control during the study and for 180 days after the last study drug administration, including: • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: o oral o intravaginal o transdermal • progestogen-only hormonal contraception associated with inhibition of ovulation: o oral o injectable o implantable • intrauterine device (IUD) • intrauterine hormone-releasing system (IUS) • bilateral tubal occlusion • vasectomized partner • sexual abstinence

Exclusion criteria 4

  1. Contraindication or hypersensitivity to any drug or metabolites from similar class as study drug or to any excipients of the study drug formulation (including lactose).
  2. Donation of 400 mL or more of blood or plasma within 8 weeks prior to first dosing
  3. Receipt of an investigational product within 90 days prior to the first dose of study drug
  4. History or presence of clinically significant ECG abnormalities or a family history or presence of prolonged QT-interval syndrome. Screening or Day -1 of Study Period 1 ECG: QTcF >450 msec; PR >210 msec; QRS complex >119 msec, or other morphological changes other than repolarization, nonspecific S-T or T-wave changes.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Plasma PK parameters including but not limited to: AUC0-last, AUC0-inf, Cmax, Tmax, CL/F, Vz/F and urine PK parameters including but not limited to Ae and Fe.

Secondary endpoints 1

  1. Safety and tolerability parameters including: physical examination, weight, AEs, clinical laboratory values, vital signs and 12-lead ECGs.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

5-Bromopyridin-3-yl 3-deoxy-3-[4-(3,4,5-trifluorophenyl)-1H-1,2,3-triazol-1-yl]-1-thio-α-D-galactopyranoside

PRD9991033 · Product

Active substance
2-5-BROMOPYRIDIN-3-YLSULFANYL-6-HYDROXYMETHYL-4-4-345-TRIFLUOROPHENYLTRIAZOL-1-YLOXANE-35-DIOL
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
100 mg milligram(s)
Max total dose
200 mg milligram(s)
Max treatment duration
4 Week(s)
Authorisation status
Not Authorised
MA holder
GALECTO BIOTECH AB
Paediatric formulation
No
Orphan designation
No

Comparator 1

5-Bromopyridin-3-yl 3-deoxy-1-thio-3-[4-(3,4,5-trifluorophenyl)-1H-1,2,3-triazol-1-yl]-alfa-D-galactopyranoside

PRD9959127 · Product

Active substance
5-BROMOPYRIDIN-3-YL 3-DEOXY-1-THIO-3-4-345-TRIFLUOROPHENYL-1H-123-TRIAZOL-1-YL-ALFA-D-GALACTOPYRANOSIDE
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
100 mg milligram(s)
Max total dose
100 mg milligram(s)
Max treatment duration
4 Week(s)
Authorisation status
Not Authorised
MA holder
GALECTO BIOTECH AB
Paediatric formulation
No
Orphan designation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Galecto Biotech AB

2 Total trials 2 Ended
Commercial
Sponsor organisation
Galecto Biotech AB
Address
Ole Maaløes Vej 3
City
Copenhagen N
Postcode
2200
Country
Denmark

Scientific contact point

Organisation
Galecto Biotech AB
Contact name
Head of Clinical Pharmacology

Public contact point

Organisation
Galecto Biotech AB
Contact name
Head of Clinical Pharmacology

Third parties 4

OrganisationCity, countryDuties
QPS Netherlands B.V.
ORG-100009393
 Groningen, Netherlands On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 14, Code 2, Interactive response technologies (IRT), Code 5, Data management, E-data capture
Labcorp Early Development Laboratories Limited
ORG-100011365
 Harrogate, United Kingdom Laboratory analysis
Iqvia Rds Ireland Limited
ORG-100009589
 Dublin 3, Ireland Code 8
Comac Medical Ltd.
ORG-100026829
 Sofia, Bulgaria Laboratory analysis

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Netherlands Ended 12 1
Rest of world — 0 —

Investigational sites

Netherlands

1 site · Ended
QPS Netherlands B.V.
Clinical Pharmacology, Hanzeplein 1, 9713 GZ, Groningen

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Netherlands 2022-12-27 2023-04-10 2023-01-03 2023-03-09

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

TitleSubmission dateStatusType
Summary of Results_2022-502200-67-00_V1
SUM-15302
 2024-02-28T10:20:23 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
Lay person summary of results_2022-502200-67-00_V1 2024-02-28T10:20:41 Submitted Laypersons Summary of Results
Lekensamenvatting van de resultaten_2022-502200-67-00_V1 2024-02-28T10:20:35 Submitted Laypersons Summary of Results

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Laypersons summary of results (for publication) Lay person summary of results_2022-502200-67-00_V1 1
Laypersons summary of results (for publication) Lekensamenvatting van de resultaten_2022-502200-67-00_V1 1
Summary of results (for publication) Summary of Results_2022-502200-67-00_V1 1

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2022-11-04 Netherlands Acceptable
2022-12-08
 2022-12-20
2 NON SUBSTANTIAL MODIFICATION NSM-1 2023-02-06 Netherlands Acceptable
2022-12-08
 2023-02-06
3 NON SUBSTANTIAL MODIFICATION NSM-3 2023-04-04 Netherlands Acceptable
2022-12-08
 2023-04-04

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