A Study to Compare Pharmacokinetics of GB1211

NCT05747573 | Completed Phase 1

• 2 other identifiers: GALBA-1GB1211-CPH-005
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  5 days

Secondary Outcomes (1)

• To determine the number of participants with adverse events

  5 weeks

Other Outcomes (1)

• To determine the relative abundance of GB1211 metabolites in plasma and in urine

  5 weeks

Study Arms (3)

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)

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)

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)

Drug: GB1211

Interventions

GB1211 DRUG

Hard tablet or capsules for oral use

A 100mg GB1211 tablet, fasted; B 100 mg GB1211 capsules, fasted; C 100 mg GB1211 tablet, fed

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Galecto Biotech AB: lead
• QPS Holdings LLC: collaborator

Study Sites (1)

QPS Netherlands BV

Groningen, 9713, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 39167148 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 28, 2023
• Study Start: January 3, 2023
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: September 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)