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The purpose of the phase 1, GTO-003 clinical study is to determine the safety and pharmacokinetics of a single dose of a new drug called GC4711 when given as an oral capsule. This study will compare capsules of GC4711 when given orally to a similar drug, GC4419, or GC4711 when either is given as an intravenous infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GC4419 IV + GC4711 Oral G-101 (82mg) | Experimental |
| |
| GC4419 IV + GC4711 Oral G-101 (164mg) | Experimental |
| |
| GC4419 IV + GC4711 Oral G-101 (246mg) | Experimental |
| |
| GC4419 IV + GC4711 Oral G-111 (175mg) | Experimental |
| |
| GC4419 IV + GC4711 Oral G-112 (145mg) | Experimental |
| |
| GC4711 IV + GC4711 Oral G-119 (233mg) | Experimental |
| |
| GC4711 IV + GC4711 Oral G-125 (233mg) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC4711 Oral Capsule G-101 | Drug | 82 mg (1 capsule) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events and Laboratory Abnormalities | Number of Participants With Treatment-Emergent Adverse Events and/or Laboratory Abnormalities. | From randomization through study completion (estimated up to 13 days) |
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Inclusion Criteria:
Healthy men and women between 18 and 50 years (inclusive) of age;
Subjects who provide written informed consent
Body Mass Index (BMI) 18 to 32 kg/m2 (inclusive) and weighing at least 50 kg during Screening and at Baseline. Every effort will be made to enroll across BMI range to evaluate relation between dose and weight;
Subjects in general good health in the investigator's opinion
Chest X-ray free of clinically significant abnormalities
Blood pressure and heart rate within normal limits
Female subjects must:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon T Holmlund, MD | Chief Medical Officer | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Melbourne | Australia |
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|
| IV GC4419 |
| Drug |
GC4419 will be infused IV as a single dose of 27 mg in 247 mL normal saline, totaling 250 mL, over a 60-minute period using a programmable pump. |
|
| GC4711 Oral Capsule G-101 | Drug | 164 mg (2 capsules) |
|
| GC4711 Oral Capsule G-101 | Drug | 246 mg (3 capsules) |
|
| GC4711 Oral Capsule G-111 | Drug | 175 mg (1 capsule) |
|
| GC4711 Oral Capsule G-112 | Drug | 145 mg (1 capsule) |
|
| GC4711 Oral Capsule G-119 | Drug | 233 mg (1 capsule) |
|
| GC4711 Oral Capsule G-125 | Drug | 233 mg (1 capsule) |
|
| IV GC4711 | Drug | GC4711 will be infused IV as a single dose of 30 mg in 250 mL normal saline, totaling 251 mL, over a 60-minute period using a programmable pump. |
|
| ID | Term |
|---|---|
| C000707700 | avasopasem manganese |
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