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In this study two MGCD265 oral formulations at dose level of 100 mg are administered to healthy male and female subjects under fasting conditions.
The objective of this study is to compare the rate and extent of absorption of two MGCD265 oral formulations at a dose level of 100 mg administered to healthy male and female subjects under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MGCD265 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MGCD265 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the bioavailability of two MGCD265 formulations. | To compare the rate and extent of absorption of two MGCD265 oral formulations at dose level of 100 mg administered as 1 x 100 mg oral dose (Formulation A) and 2 x 50 mg oral dose (Formulation B) under fasting conditions. | Two months |
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Inclusion Criteria:
Healthy male or female subjects ≥18 to ≤55 years of age who are willing and able to provide informed consent prior to performing any study related procedures
Females of childbearing potential who are using a stable contraceptive method at least 30 days prior to screening and who are willing to use one of the following acceptable birth control methods until 30 days after the last dose of study drug:
Female subjects will be considered of non childbearing potential and eligible if one of the following condition is met:
Male subjects must agree to be abstinent or use the following acceptable contraception methods in collaboration with their female partner from the time of taking the first dose until 3 months after the last dose of study drug:
Male subjects also agree to not donate sperm from the time of taking the first dose of study drug until 3 months after the last dose of study drug
Subject with a body mass index (BMI) of 18.0 to 32.0 kg/m2 at screening
Subject is a current non-smoker and has not used any nicotine containing product within 3 months prior to screening
Subjects who are considered generally healthy upon completion of medical history, physical examination, vital signs, screening laboratory results and screening ECG as judged by the investigator
Subjects who are willing and able to comply with the visit schedule, treatment plan, laboratory tests, pharmacokinetic sampling schedule and other study procedures
Exclusion Criteria:
No subjects will be allowed to enroll in this study more than once (i.e. if the study is conducted with more than 1 group).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vince & Associates Clinical Research, Inc. | Overland Park | Kansas | 66212 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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