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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001201-17 | EudraCT Number |
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This first-in-human (FIH) study will provide the first safety and pharmacokinetic (PK) data for G1T38 in humans and will allow further development of G1T38 in patients with cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | G1T38 or placebo |
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| Cohort 2 | Experimental | G1T38 or placebo |
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| Cohort 3 | Experimental | G1T38 or placebo |
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| Cohort 4 | Experimental | G1T38 or placebo |
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| Cohort 5 | Experimental | G1T38 or placebo |
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| Cohort 6 | Experimental | G1T38 or placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G1T38 (CDK 4/6 Inhibitor) | Drug | CDK 4/6 Inhibitor |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Related Adverse Event, including Abnormal Laboratory Events | All AEs, including clinical laboratory, vitals signs, physical examinations and ECGs will be analyzed in all subjects receiving study drug through 7 days post dose of study drug. | Up to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of G1T38: Maximum Plasma Concentration (Cmax) | The observed peak plasma concentration determined from the plasma | Day 1, 2, 3, 4 and 5 |
| Pharmacokinetics of G1T38: Area under Curve - plasma concentration (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Regner Tiessen, MD | PRA Early Development Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Early Development Clinic | Groningen | Netherlands |
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| Cohort 7 | Experimental | G1T38 or placebo |
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| Cohort 8 | Experimental | G1T38 or placebo |
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| Cohort 9 - Food Effect | Experimental | G1T38 |
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| Cohort 10 | Experimental | G1T38 or placebo |
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| Cohort 11 | Experimental | G1T38 or placebo |
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| Cohort 12 | Experimental | G1T38 or placebo |
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| Placebo | Drug | Placebo |
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Area under the plasma concentration-time curve
| Day 1, 2, 3, 4 and 5 |
| Pharmacokinetics of G1T38: Plasma: terminal half life (T1/2) | G1T38: Plasma- terminal half life (T1/2) | Day 1, 2, 3, 4 and 5 |
| Pharmacokinetics of G1T38: Plasma - Volume of distribution | Volume of distribution in the terminal elimination phase | Day 1, 2, 3, 4 and 5 |