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
Overview
- Phase
- Phase 1
- Intervention
- GB1211
- Conditions
- Pharmacokinetics
- Sponsor
- Galecto Biotech AB
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- To measure the fraction of GB1211 excreted in urine (Fe)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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
Detailed Description
This is relative bioavailability and food effect study to enable further clinical development of a tablet formulation of GB1211.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
- •intravaginal
- •transdermal
- •progestogen-only hormonal contraception associated with inhibition of ovulation:
- •injectable
- •implantable
Exclusion Criteria
- •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
- •History of cardiac disease such as:
- •Presence of clinically significant ventricular or atrial arrhythmia;
Arms & Interventions
A 100mg GB1211 tablet, fasted
Single dose of 100 mg GB1211 as a tablet (100 mg strength) under fasted conditions (n=4 per period)
Intervention: GB1211
B 100 mg GB1211 capsules, fasted
Single dose of 100 mg GB1211 as two capsules (50 mg strength) under fasted conditions (n=4 per period)
Intervention: GB1211
C 100 mg GB1211 tablet, fed
Single dose of 100 mg GB1211 as a tablet (100 mg strength) under fed conditions (n=4 per period)
Intervention: GB1211
Outcomes
Primary Outcomes
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.
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 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.
Secondary Outcomes
- To determine the number of participants with adverse events(5 weeks)