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This study is designed to assess the effect of food and antacid use on the pharmacokinetic properties of BIIB021.
This study has 2 phases (the Food Phase and the Antacid Phase), each consisting of a 2-period, 2-sequence, 2-treatment crossover design. The Food Phase will assess the effect of a high fat meal on the pharmacokinetics of 100 mg BIIB021, and the Antacid Phase will assess the effect of an antacid (ranitidine) on the pharmacokinetics of 450 mg BIIB021 in the same subjects. Ranitidine 150 mg will be taken the evening before and the morning of the antacid dosing day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIB021 and Food | Experimental | The food phase will assess the effect of a high fat meal on the pharmacokinetics of BIIB021. |
|
| BIIB021 and Antacid | Experimental | Antacid phase will assess the effect of an antacid on the pharmacokinetics of BIIB021. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB021 and Food | Drug | Assessing the effect of food use on BIIB021 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of the study is to assess the pharmacokinetics of BIIB021 taken under fed conditions compared to BIIB021 taken under fasting conditions in subjects with advanced solid tumors. | Cycle 1, Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the pharmacokinetics of BIIB021 taken with an antacid (ranitidine) compared to BIIB021 taken with no antacid, both under fasting conditions | Cycle 1, Day 8 and Day 10 | |
| To evaluate the safety and tolerability of BIIB021 | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reseach Facility | Scottsdale | Arizona | United States | |||
| Reseach Facility |
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| ID | Term |
|---|---|
| C521963 | 6-chloro-9-(4-methoxy-3,5-dimethylpyridin-2-ylmethyl)-9H-purin-2-ylamine |
| D005502 | Food |
| D000863 | Antacids |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D045504 | Molecular Mechanisms of Pharmacological Action |
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| BIIB0121 and Antacid |
| Drug |
Assessing the effect of antacid use on BIIB021 |
|
| To evaluate the antitumor activity of BIIB021 | 6 months |
| To evaluate the effect of BIIB021 on pharmacodynamic biomarkers. | 6 months |
| Encinitas |
| California |
| United States |
| Reseach Facility | San Antonio | Texas | United States |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D005765 | Gastrointestinal Agents |
| D045506 | Therapeutic Uses |