PharmacokineticsPhase 1NCT05747573
A Study to Compare Pharmacokinetics of GB1211
A Phase 1 study testing GB1211 in people with Pharmacokinetics, run by Galecto Biotech AB at 1 site in Netherlands.
Trial summary
This study is 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- GB1211
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Jan 2023to 10 Apr 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
- Subjects must provide written informed consent prior to any Screening procedures being performed.
- Male and female subjects 18-55 years of age (inclusive) on the day of signing the informed consent.
- 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 electrocardiogram (ECG).
- Women of child-bearing potential (WOCP) 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:
- oral
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- intravaginal
- transdermal
- progestogen-only hormonal contraception associated with inhibition of ovulation:
- oral
- injectable
- implantable
- intrauterine device (IUD)
- intrauterine hormone-releasing system (IUS)
- bilateral tubal occlusion
- vasectomized partner
- sexual abstinence
- Postmenopausal women must have had ≥12 months of spontaneous amenorrhea (with documented follicle-stimulating hormone (FSH) ≥30 mIU/mL). Surgically sterile women are defined as those who have had a hysterectomy, bilateral ovariectomy, or bilateral tubal ligation. Women who are surgically sterile must provide documentation of the procedure.
- Sexually active male subjects must use a barrier method of contraception (condom) and refrain from sperm donation during the study and for at least 90 days after the last study drug administration if their female sexual partner is of childbearing potential. Acceptable methods of birth control for female partners of male subjects are: hormonal contraceptives (oral contraceptives, implant or injection), intrauterine device (placed at least 1 month before the start of the study). Surgical sterilization of male patients can be accepted as a form of birth control if the sterilization procedure took place at least 6 months prior to the start of the study.
- Adequate venous access for blood sampling.
- Body mass index (BMI) between 18.0 to 32.0 kg/m2 (inclusive) at Screening.
- Body temperature between 35.5-37.5 ºC (inclusive) at Screening and on Day -1 of Study Period 1.
- Subjects agree to be available for the entire duration of the study and to be able to adhere to the study restrictions and examination schedule.
- Able to swallow medication.
- Subjects must be able to communicate well with the investigator and to comply with the requirements of the entire study.
Who cannot join
- 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).
- Donation of 400 mL or more of blood or plasma within 8 weeks prior to first dosing.
- Receipt of an investigational product within 90 days prior to the first dose of study drug.
- 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 >450msec; PR >210 msec; QRS complex >119 msec, or other morphological changes other than repolarization, nonspecific S-T or T-wave changes.
- Abnormal vital signs, after 5 minutes supine rest at Screening or on Day -1 of Study Period 1, defined as any of the following:
- Systolic blood pressure of < 90 or > 140 mmHg
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- Diastolic blood pressure of < 45 or > 90 mmHg
- Pulse rate < 40 or > 100 bpm One (1) re-test may be performed at Screening and Day -1 of Study Period 1.
- History of cardiac disease such as:
- Presence of clinically significant ventricular or atrial arrhythmia;
- History of clinically documented myocardial infarction;
- History of unstable angina pectoris;
- Other clinically significant cardiovascular disease (e.g., congestive heart failure).
- Any positive result at Screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV), and on Day -1 for COVID-19.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs. The investigator is to be guided by evidence of any of the following: history of major gastrointestinal surgery such as gastrectomy, gastroenterostomy, bowel resection or cholecystectomy. Subjects with a history of appendectomy are eligible to participate.
- History of psychiatric illness within the past 2 years that may interfere with the ability to comply with the protocol requirements.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within 5 years, regardless of whether there is recurrence or metastases.
- Smokers (use of tobacco or nicotine-containing products in the previous 3 months) and not willing to abstain from using tobacco or nicotine-containing products during the study. Positive cotinine test results at Screening or Day -1 are reason for exclusion. One (1) cotinine re-test may be performed at Screening and on Day -1 for otherwise eligible subjects who were recently exposed to passive smoke inhalation.
- History of drug or alcohol abuse within 12 months prior to first dose and/or a positive urine drug screen/alcohol breath test at Screening or Day -1 of Study Period 1.
- Use of any prescription or non-prescription medication including vaccination (excluding paracetamol, hormonal contraceptives), herbal medication, dietary supplements, or vitamins within 14 days prior to first dosing.
- Administration of CYP3A4/5 inhibitors or inducers within 4 weeks prior to first dosing.
- Administration of P-gp inhibitors or inducers within 4 weeks prior to first dosing.
- Administration of medications that prolong the QT interval within 4 weeks prior to first dosing.
- A positive pregnancy test at Screening or Day -1 of Study Period 1 or lactation.
- Potentially unreliable or vulnerable subjects (e.g., person kept in detention) and those judged by the investigator to be unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
This study is 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
Read the detailed description
This is relative bioavailability and food effect study to enable further clinical development of a tablet formulation of GB1211.
- Conditions
- Pharmacokinetics
- Being tested
- GB1211
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB1211Drug
Hard tablet or capsules for oral use
| Study group | Role | What they receive |
|---|---|---|
| A 100mg GB1211 tablet, fasted | Active comparator | Single dose of 100 mg GB1211 as a tablet (100 mg strength) under fasted conditions (n=4 per period) Receives: Drug: GB1211 |
| B 100 mg GB1211 capsules, fasted | Active comparator | Single dose of 100 mg GB1211 as two capsules (50 mg strength) under fasted conditions (n=4 per period) Receives: Drug: GB1211 |
| C 100 mg GB1211 tablet, fed | Active comparator | Single dose of 100 mg GB1211 as a tablet (100 mg strength) under fed conditions (n=4 per period) Receives: Drug: GB1211 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the maximum plasma concentration of GB1211 (Cmax)
Timepoints for PK sampling
Period 1: Day 1: pre-dose and at hrs 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose.
Period 2: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose.
Period 3: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose.
Measured: 5 weeks
To measure the time to reach Cmax GB1211 (Tmax)
Timepoints for PK sampling
Period 1: Day 1: pre-dose and at hrs 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose.
Period 2: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose.
Period 3: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose.
Measured: 5 weeks
To measure the area under the plasma concentration-time curve of GB1211 (AUC)
Timepoints for PK sampling for
Period 1: Day 1: pre-dose and at hrs 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose.
Period 2: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose.
Period 3: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose.
Measured: 5 weeks
To measure the amount of GB1211 excreted in urine (Ae)
Study Period 1: Pre-dose (single sample) and at [0 to 6 h], [6 to 12 h] (Day 1), [12 to 24 h] (Day 2), [24 to 48 h] (Day 3), [48 to 72 h] (Day 4), [72 to 96 h] (Day 5) post-dose.
Measured: 5 days
To measure the fraction of GB1211 excreted in urine (Fe)
Study Period 1: Pre-dose (single sample) and at [0 to 6 h], [6 to 12 h] (Day 1), [12 to 24 h] (Day 2), [24 to 48 h] (Day 3), [48 to 72 h] (Day 4), [72 to 96 h] (Day 5) post-dose.
Measured: 5 days
Secondary outcomes (1)
To determine the number of participants with adverse events
Number of participants with adverse events graded as mild, moderate, or severe according to the study protocol.
Number of participants with adverse events related and not related to the study drug.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start3 Jan 2023
- Primary completion10 Apr 2023
- Study completion10 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PharmacokineticsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galecto Biotech AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- QPS Holdings LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747573
- Sponsor's protocol ID
- GALBA-1
- Other IDs
- GB1211-CPH-005
- Status last verified
- Feb 2023
- First submitted
- 26 Jan 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aslanis V, Abd-Elaziz K, Slack RJ, Brinch A, Gravelle L, Morley W, Phung D, Herman K, Holyer I, Poulsen KK, Dogterom P, Tantawi S, Zetterberg FR, Jacoby B, Schambye H, Lindmark B. Relative bioavailability and food effect of the galectin-3 inhibitor selvigaltin (GB1211) administered as a tablet in healthy participants (GALBA-1). Cancer Chemother Pharmacol. 2024 Nov;94(5):707-720. doi: 10.1007/s00280-024-04710-3. Epub 2024 Aug 21.
PubMed 39167148
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05747573
- Acronym / sponsor ID
- GALBA-1
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Galecto Biotech ABIndustry (pharma, biotech, devices)
- Collaborators
- QPS Holdings LLC
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 28 Feb 2023 (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 study is 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
Detailed description
This is relative bioavailability and food effect study to enable further clinical development of a tablet formulation of GB1211.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A 100mg GB1211 tablet, fasted | Active comparator | Drug: GB1211Single dose of 100 mg GB1211 as a tablet (100 mg strength) under fasted conditions (n=4 per period) |
| B 100 mg GB1211 capsules, fasted | Active comparator | Drug: GB1211Single dose of 100 mg GB1211 as two capsules (50 mg strength) under fasted conditions (n=4 per period) |
| C 100 mg GB1211 tablet, fed | Active comparator | Drug: GB1211Single dose of 100 mg GB1211 as a tablet (100 mg strength) under fed conditions (n=4 per period) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (25 listed)
- Subjects must provide written informed consent prior to any Screening procedures being performed.
- Male and female subjects 18-55 years of age (inclusive) on the day of signing the informed consent.
- 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 electrocardiogram (ECG).
- Women of child-bearing potential (WOCP) 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:
- Postmenopausal women must have had ≥12 months of spontaneous amenorrhea (with documented follicle-stimulating hormone (FSH) ≥30 mIU/mL). Surgically sterile women are defined as those who have had a hysterectomy, bilateral ovariectomy, or bilateral tubal ligation. Women who are surgically sterile must provide documentation of the procedure.
Key exclusion criteria (25 listed)
- 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).
- Donation of 400 mL or more of blood or plasma within 8 weeks prior to first dosing.
- Receipt of an investigational product within 90 days prior to the first dose of study drug.
- 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 >450msec; PR >210 msec; QRS complex >119 msec, or other morphological changes other than repolarization, nonspecific S-T or T-wave changes.
- Abnormal vital signs, after 5 minutes supine rest at Screening or on Day -1 of Study Period 1, defined as any of the following:
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 |
|---|---|---|
| GB1211Hard tablet or capsules for oral use | Drug | A 100mg GB1211 tablet, fasted, B 100 mg GB1211 capsules, fasted, C 100 mg GB1211 tablet, fed |
Primary outcome
To measure the maximum plasma concentration of GB1211 (Cmax)
Time frame: 5 weeks
Timepoints for PK sampling Period 1: Day 1: pre-dose and at hrs 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose. Period 2: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose. Period 3: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose.
To measure the time to reach Cmax GB1211 (Tmax)
Time frame: 5 weeks
Timepoints for PK sampling Period 1: Day 1: pre-dose and at hrs 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose. Period 2: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose. Period 3: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose.
To measure the area under the plasma concentration-time curve of GB1211 (AUC)
Time frame: 5 weeks
Timepoints for PK sampling for Period 1: Day 1: pre-dose and at hrs 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose. Period 2: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose. Period 3: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose.
To measure the amount of GB1211 excreted in urine (Ae)
Time frame: 5 days
Study Period 1: Pre-dose (single sample) and at [0 to 6 h], [6 to 12 h] (Day 1), [12 to 24 h] (Day 2), [24 to 48 h] (Day 3), [48 to 72 h] (Day 4), [72 to 96 h] (Day 5) post-dose.
To measure the fraction of GB1211 excreted in urine (Fe)
Time frame: 5 days
Study Period 1: Pre-dose (single sample) and at [0 to 6 h], [6 to 12 h] (Day 1), [12 to 24 h] (Day 2), [24 to 48 h] (Day 3), [48 to 72 h] (Day 4), [72 to 96 h] (Day 5) post-dose.
1 secondary outcome
To determine the number of participants with adverse events
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Derived from this study: PubMed 39167148Aslanis V, Abd-Elaziz K, Slack RJ, Brinch A, Gravelle L, Morley W, Phung D, Herman K, Holyer I, Poulsen KK, Dogterom P, Tantawi S, Zetterberg FR, Jacoby B, Schambye H, Lindmark B. Relative bioavailability and food effect of the galectin-3 inhibitor selvigaltin (GB1211) administered as a tablet in healthy participants (GALBA-1). Cancer Chemother Pharmacol. 2024 Nov;94(5):707-720. doi: 10.1007/s00280-024-04710-3. Epub 2024 Aug 21.
- 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 GB1211 in people with Pharmacokinetics, run by Galecto Biotech AB at 1 site in Netherlands.
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 25 inclusion and 25 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 1 Sep 2023. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To measure the maximum plasma concentration of GB1211 (Cmax) (time frame: 5 weeks). 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?
On the ClinicalTrials.gov record for NCT05747573, 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 1 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.