Status:
COMPLETED
The Effects of Castration on the Pharmacokinetics of Zolpidem After Single Dose Administration In Men With Prostate Cancer Undergoing Androgen Deprivation Therapy Compared to Normal Healthy Females
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Prostatic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Background: Insomnia is associated with difficulty sleeping. The drug zolpidem is widely prescribed for insomnia. Women have reported worse effects from the drug than men. Women have higher amounts o...
Detailed Description
Background: * Zolpidem is currently approved for the treatment of patients with insomnia. * Women reported experiencing an increased incidence of adverse effects than men, resulting in a reduction of...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA - FOR MALE COHORT:
- Patients must have histologically or cytologically confirmed prostate cancer. Note: If histologic documentation is unavailable, a clinical course consistent with prostate cancer is acceptable.
- Patients must be eligible for and must be planning to undergo androgen deprivation therapy
- Testosterone levels greater than or equal to 100 ng/dL
- Patients must have progressive prostate cancer as indicated by either prostate-specific antigen (PSA) progression (PSA progression is defined as two consecutively rising PSAs above the nadir post- definitive therapy and an absolute value greater than 1.0 ng/mL separated by at least 2 weeks) or radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Prostate Cancer Working Group 3 (PCWG3).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Patients must have normal organ and marrow function as defined below:
- Hemoglobin greater than or equal to 9 g/dL
- leukocytes greater than or equal to 3,000/mcL
- absolute neutrophil count greater than or equal to 1,500/mcL
- platelets greater than or equal to 150,000/mcL
- total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT) serum glutamic-pyruvic transaminase (SGPT) less than or equal to institutional upper limit of normal
- creatinine within normal institutional limits OR creatinine clearance greater than or equal to 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal (calculated via Cockcroft-Gault equation)
- Patients must not have other concurrent malignancies (within the past 2 years with the exception of non-melanoma skin cancer and Rai Stage 0 chronic lymphocytic leukemia), in situ carcinoma of any site, or life-threatening illnesses, including untreated infection (must be at least 1 week off intravenous antibiotic therapy before beginning zolpidem).
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Ability to swallow study medication.
- Willingness to travel to National Institutes of Health (NIH) for follow-up visits.
- Men age greater than or equal to 18 years of age. Children are excluded because prostate cancer is not common in pediatric populations.
- INCLUSION CRITERIA - FOR NORMAL HEALTHY FEMALE COHORT:
- Females age greater than or equal to 18 years of age
- Good health conditions or without significant diseases, according to best medical judgement.
- If breastfeeding, must be willing to discard breastmilk for 24 hours following zolpidem.
- Ability if subject to understand and the willingness to sign a written informed consent Ability to swallow study medication.
- EXCLUSION CRITERIA - FOR MALE COHORT:
- Patients who are receiving any other investigational agents (in the past 28 days) or herbal medications (within 1 day).
- Patients who have received systemic chemotherapy for prostate cancer will not be eligible.
- Known hypersensitivity to Zolpidem or chemically related compounds; history of serious adverse reactions or hypersensitivity to any drug.
- Clinically significant cardiac disease, e.g. New York Heart Association (NYHA) classes III-IV; uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous 6 months as confirmed by an electrocardiogram (ECG).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with zolpidem. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
- Patients with known active treatment for Hepatitis B and C infections.
- Patients who are taking medications that may alter the metabolism of zolpidem. This includes strong Cytochrome P450 3A4 (CYP3A4) inhibitors or inducers or CYP3A4 substrates with a narrow therapeutic index. For a current table of Substrates, Inhibitors and Inducers please access the following website: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm093664.htm
- History or presence of hepatic or gastrointestinal diseases, or other condition that interferes with drug absorption, distribution, excretion or metabolism.
- Patients currently taking other sedative hypnotic medications Patients with a known history of psychiatric issues
- Patients at risk for fall or who have had recent fractures
- Patients of Asian descent
- EXCLUSION CRITERIA - FOR NORMAL HEALTHY FEMALE COHORT:
- Chronic therapy with any drugs, except contraceptives
- History of hepatic, kidney, lungs, gastrointestinal, epileptic, hematologic or psychiatric disease; hypotension or hypertension, of any etiology, that requires pharmacological treatment; history of myocardial infarction, angina and/or heart failure.
- Use of regular medications within 2 weeks prior study enrollment or use of any medications within one week prior to study enrollment, except contraceptives or cases which, based on drugs or metabolites half-life, complete elimination can be assumed.
- Hospitalization for any reason up to 8 weeks before enrollment.
- Any condition, according to investigator's best judgement, that prevents the subject to participate in the trial
- Pregnancy, labor or miscarriage within 12 weeks before admission predicted date.
- Known hypersensitivity to zolpidem or chemically related compounds; history of serious adverse reactions or hypersensitivity to any drug.
- Females of Asian descent
- History of taking estrogen derivatives, androgens, or similar hormonal replacement or supplementation products. Past and current use of hormonal contraceptives is allowed.
Exclusion
Key Trial Info
Start Date :
January 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03436745
Start Date
January 22 2019
End Date
January 30 2024
Last Update
February 11 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892