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Trial · Interventional

TerminatedPhase 1Results postedRegistry data

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

NCTNCT03436745 (opens ClinicalTrials.gov in a new tab)Other id180058Other id18-C-0058

This trial does not test a peptide that PepBank tracks.

  • Names Goserelin, does not test it. It appears in the description.

Overview

Status
Terminated
Phase
Phase 1
Enrollment
12 participants (actual)
Sponsor
National Cancer Institute (NCI) · Nih
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
22 Jan 2019
Primary completion
30 Jan 2024
Completion
30 Jan 2024
First posted
19 Feb 2018
Last update posted
26 Jun 2026
Conditions
Prostatic Neoplasms

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022202320242025
  1. Ph 1

    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

    NCT03436745

    22 Jan 2019 to 30 Jan 2024

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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 of zolpidem in their body that may persist after waking. Drug exposure may also depend on male hormones that change during prostate cancer therapy. Researchers want to see if these findings can provide a more-accurate dose to healthy women and men with prostate cancer. Objective: To study amounts of zolpidem in men who have been diagnosed with prostate cancer before they are castrated and after, and to compare these results to healthy women s. Eligibility: Men ages 18 and older who have been diagnosed with prostate cancer who are planning to receive androgen deprivation therapy (ADT) Healthy women age 18 and older Design: Participants will be screened with: Blood tests Physical exam Electrocardiogram (EKG) heart test Male participants will confirm their prostate cancer. This can be done with a tumor sample tissue from a previous surgery or a report from a doctor. Female participants may have a pregnancy test. Participants will be admitted to the clinic in the evening and stay overnight. They will: Take a 5 mg zolpidem tablet on an empty stomach around 11 p.m. Have blood drawn multiple times Have physical exams and EKGs Answer questions about their symptoms and medicines they are taking Male participants will have ADT as part of their standard cancer treatment. After that, the testosterone in their blood will be measured. They will repeat the overnight clinic stay. Participants will get a follow-up phone call after each stay.

Interventions

  • ZolpidemDrug
  • ECGDiagnostic test

Arms2

  • Active comparator

    Female

    Single 5 mg oral dose of zolpidem

  • Experimental

    Zolpidem pre and post castration

    5 mg oral dose of zolpidem prior to undergoing androgen deprivation therapy (ADT) followed by 5 mg oral dose of zolpidem after ADT and testosterone reaches castrate levels

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Area Under the Plasma Concentration 0-8Hour (Hr)(AUC0-8hr) Values in Males Between Pre-Androgen Deprivation Therapy (ADT) and Post-ADT

    Time frame · pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, and 8-hours post-dose.

    Registry description

    AUC is a measure of the serum concentration of Zolpidem over time. It is used to characterize drug absorption. The AUC values will be compared between the time points for males to see if the AUC increases significantly. Pre-ADT males will be subtracted from the paired values in males once they are post-ADT and tested for a difference using a paired t-test with a two-sided 0.05 significance level, or a Wilcoxon signed rank test if the paired differences are not normally distributed.

Secondary outcomes(1)
  1. Comparison of Area Under the Plasma Concentration 0-8Hour (Hr)(AUC0-8hr) Values Between Post-Androgen Deprivation Therapy (ADT) Males and Healthy Female Participants

    Time frame · pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, and 8-hours post-dose.

    Registry description

    AUC is a measure of the serum concentration of Zolpidem over time. It is used to characterize drug absorption. AUC values will be compared between those of post-ADT males and healthy females to assess whether AUC values are approximately equivalent between post-ADT males and healthy females.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, and 8-hours post-dose.

Change in Area Under the Plasma Concentration 0-8Hour (Hr)(AUC0-8hr) Values in Males Between Pre-Androgen Deprivation Therapy (ADT) and Post-ADT

GroupValue (Hr*ng/mL)
Prostate Cancer Cohort: Zolpidem Pre-Castration484.65
Prostate Cancer Cohort: Zolpidem Post Castration473.05
Secondary and other outcome results(2)
Secondary outcomeMean· pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, and 8-hours post-dose.

Comparison of Area Under the Plasma Concentration 0-8Hour (Hr)(AUC0-8hr) Values Between Post-Androgen Deprivation Therapy (ADT) Males and Healthy Female Participants

GroupValue (Hr*ng/mL)
Healthy Female Cohort: One Time Zolpidem242
Prostate Cancer Cohort: Zolpidem Post Castration473.05
Other pre specified outcomeCount of participants· Study Period 1, Day 1 to Day 3 (female &male cohort). From first intervention, Study Period Day 1 to 3 days after removal from study treatment, approximately 3 days. Study Period 2, Day 1 to Day 3 (male cohort) after removal from study treatment, =3 days.

Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).

GroupValue (Participants)
Healthy Female Cohort: One Time Zolpidem1
Prostate Cancer Cohort: Zolpidem Pre and Post Castration1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Healthy Female Cohort: One Time ZolpidemNormal healthy females (n=5-8) will receive treatment with a single dose of 5 mg tablet of zolpidem.0 / 100 / 101 / 10
Prostate Cancer Cohort: Zolpidem Pre and Post Castration5 mg oral dose of zolpidem prior to undergoing androgen deprivation therapy (ADT) followed by 5 mg oral dose of zolpidem after ADT and testosterone reaches castrate levels Zolpidem: In men with prostate cancer, males (pre-castration) will receive oral zolpidem in the form of a 5 mg tablet. This cohort of men will then undergo androgen deprivation therapy with standard doses of goserelin. When castrate testosterone levels reach \<50 ng/dL (post-castration), they will receive another 5 mg single dose of zolpidem.0 / 10 / 11 / 1

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
* 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.

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