Last updated on June 2019

Study to Compare Capsule and Liquid Formulations of Enzalutamide After Single Dose Administration Under Fasting Conditions in Prostate Cancer


Brief description of study

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.

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Detailed Study Description

Background
  • Enzalutamide is currently approved for the treatment of patients with 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

Clinical Study Identifier: NCT03478904

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Recruitment Status: Open


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