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| Name | Class |
|---|---|
| Medpace, Inc. | INDUSTRY |
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The purpose of this study is to compare relative oral bioavailability of a capsule formulation of LGD-6972 to a solution formulation of LGD-6972.
This is a single center, randomized, open-label, single dose study conducted in a 2-way crossover design.
A total of 8 subjects will be enrolled in the study. The duration of participation for each subject will be approximately 36 days, not including a Screening Period of up to 30 days.
Each treatment period, subjects will be admitted to the study site on Day -1 and observed through the morning of Day 3 (48-hour post-dose assessment). Over 2 treatment periods, subjects will receive each of the following treatments as a single dose orally, under fasting conditions, per the randomization (4 subjects per treatment in each treatment period:
Treatment A - 15 mg of LGD-6972 as capsules
Treatment B - 15 mg LGD-6972 as solution
Serial blood samples will be collected through 48 hours following each dose to determine the concentration of LGD 6972 in plasma. Safety assessments will also occur during this time. Subjects will be discharged from the study site after the 48 hour assessments and return to the study site on Days 4, 7, and 14 for follow up procedures. Subjects will return to the study site for the second treatment period after an additional 7 days. Subjects will be discharged from the study after returning to the study site on Day 14 of the second treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 Treatment A | Experimental | Healthy subjects will receive a single dose orally of LGD-6972 capsules fasted |
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| Period 1 Treatment B | Experimental | Healthy subjects will receive a single dose orally of LGD-6972 solution fasted |
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| Period 2 Treatment A | Experimental | Healthy subjects will receive a single dose orally of LGD-6972 capsules fasted |
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| Period 2 Treatment B | Experimental | Healthy subjects will receive a single dose orally of LGD-6972 solution fasted |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LGD-6972 Solution | Drug | 15 mg of LGD-6972 |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Analysis- Area Under the Concentration Curve (AUC) | AUC: ratio: medium test form to reference form | Pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hrs, 7 and 14 days post dose |
| Pharmacokinetics Analysis- Maximum Concentration (Cmax) | Cmax: ratio: medium test form to reference form | Pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hrs, 7 and 14 days post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of all Adverse Events graded according to the Common Terminology Criteria for Adverse Events (CTCAE) | The severity of all adverse events will be graded according to the CTCAE version 4.0 from dosing until 14 days post-dose | Day -1, 24, 48, 72hrs, and 7day and 14day post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lukasz Biernat, M.D. | Medpace Clinical Pharmacology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medpace, Inc | Cincinnati | Ohio | 45227 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C093196 | SBE4-beta-cyclodextrin |
| C031215 | betadex |
| C000624432 | RVT-1502 |
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| LGD-6972 Capsules | Drug | 15 mg LGD-6972 |
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| D004700 | Endocrine System Diseases |