Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT03478904
Status:
TERMINATED
Last Update Posted:
2021-05-10
First Post:
2018-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Compare Capsule and Liquid Formulations of Enzalutamide After Single Dose Administration Under Fasting Conditions in Prostate Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Study to Compare Capsule and Liquid Formulations of Enzalutamide After Single Dose Administration Under Fasting Conditions in Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study drug is now commercially available in tablet format
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background:
Enzalutamide is given to treat metastatic prostate cancer. But it takes 4 pills to deliver the effective dose. This can be difficult for people already taking multiple drugs. And swallowing may be difficult for some people. Researchers want to test out a new way of giving enzalutamide by mouth. They want to see if giving a person the liquid taken from inside the standard 4 gelatin capsules is handled by the body in the same way as giving them the capsules whole.
Objectives:
To compare how capsule and liquid forms of enzalutamide are handled by people with prostate cancer.
Eligibility:
Men at least 18 years old with prostate cancer
Design:
Participants will be screened with a heart test (electrocardiogram), medical history, and physical exam. A tissue sample or lab reports will be reviewed.
During the study, participants will repeat screening tests and have urine tests.
Participants will be randomly assigned to get the study drug in one of two orders: either the as capsules then the liquid form (Arm A) or as the liquid form then the capsule form (Arm B).
Participants will be counseled about birth control.
The study will have 2 periods with a minimum 42 day break in between.
On Day 1 of Period 1 and Day 1 of Period 2, participants will be admitted to the hospital. They will get one dose of the study drug. They cannot eat or drink anything except water for at least 10 hours before and for 4 hours after the study drug. Their blood will be sampled over 24 hours. Lunch and dinner will be served. Participants will answer questions after taking the liquid form.
Participants will have blood drawn on Day 3, Day 8, and Day 42.
Enzalutamide is given to treat metastatic prostate cancer. But it takes 4 pills to deliver the effective dose. This can be difficult for people already taking multiple drugs. And swallowing may be difficult for some people. Researchers want to test out a new way of giving enzalutamide by mouth. They want to see if giving a person the liquid taken from inside the standard 4 gelatin capsules is handled by the body in the same way as giving them the capsules whole.
Objectives:
To compare how capsule and liquid forms of enzalutamide are handled by people with prostate cancer.
Eligibility:
Men at least 18 years old with prostate cancer
Design:
Participants will be screened with a heart test (electrocardiogram), medical history, and physical exam. A tissue sample or lab reports will be reviewed.
During the study, participants will repeat screening tests and have urine tests.
Participants will be randomly assigned to get the study drug in one of two orders: either the as capsules then the liquid form (Arm A) or as the liquid form then the capsule form (Arm B).
Participants will be counseled about birth control.
The study will have 2 periods with a minimum 42 day break in between.
On Day 1 of Period 1 and Day 1 of Period 2, participants will be admitted to the hospital. They will get one dose of the study drug. They cannot eat or drink anything except water for at least 10 hours before and for 4 hours after the study drug. Their blood will be sampled over 24 hours. Lunch and dinner will be served. Participants will answer questions after taking the liquid form.
Participants will have blood drawn on Day 3, Day 8, and Day 42.
Detailed Description:
Background:
* Enzalutamide is currently approved for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC)
* The marketed (reference) formulation of enzalutamide is a liquid-filled, soft gelatin capsule containing 40 mg enzalutamide dissolved in Labrasol; four such capsules are required to deliver a 160 mg dose
* The four-capsule regimen is inconvenient because of the number of capsules that must be taken, particularly in light of the fact that cancer patients usually have to take multiple drugs.
* Additionally, some patients may not be able to swallow pills; therefore, alternate methods of oral administration are necessary
Objectives:
-To evaluate the bioequivalence, safety, and tolerability of two oral formulations of enzalutamide following a single 160 mg dose in male subjects with prostate cancer under fasting conditions.
Eligibility:
-Male subjects with prostate cancer
Design:
* Comparative, randomized, open-label, single-dose, 2-way crossover bioavailability, safety and tolerability study
* Subjects will be randomized in Period 1 to one of two sequences: AB or BA. Following a minimum 42-day washout period, subjects will be crossed over in Period 2 to receive the treatment that they did not receive in Period 1.
* Treatment A will be the standard capsule (reference) formulation; Treatment B will be the liquid formulation (test product)
* Blood samples will be collected for pharmacokinetic analysis
* Enzalutamide is currently approved for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC)
* The marketed (reference) formulation of enzalutamide is a liquid-filled, soft gelatin capsule containing 40 mg enzalutamide dissolved in Labrasol; four such capsules are required to deliver a 160 mg dose
* The four-capsule regimen is inconvenient because of the number of capsules that must be taken, particularly in light of the fact that cancer patients usually have to take multiple drugs.
* Additionally, some patients may not be able to swallow pills; therefore, alternate methods of oral administration are necessary
Objectives:
-To evaluate the bioequivalence, safety, and tolerability of two oral formulations of enzalutamide following a single 160 mg dose in male subjects with prostate cancer under fasting conditions.
Eligibility:
-Male subjects with prostate cancer
Design:
* Comparative, randomized, open-label, single-dose, 2-way crossover bioavailability, safety and tolerability study
* Subjects will be randomized in Period 1 to one of two sequences: AB or BA. Following a minimum 42-day washout period, subjects will be crossed over in Period 2 to receive the treatment that they did not receive in Period 1.
* Treatment A will be the standard capsule (reference) formulation; Treatment B will be the liquid formulation (test product)
* Blood samples will be collected for pharmacokinetic analysis
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 18-C-0070 | None | None | View |