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.
Additional locations may be listed on ClinicalTrials.gov for NCT03436745.
See trial information on ClinicalTrials.gov for a list of participating sites.
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 the recommended dose of zolpidem for women.
- Zolpidem metabolism is affected by both age and gender; the recommended dose for the
elderly and female populations is 5mg daily.
- Subsequent studies have shown that women experience greater exposure to zolpidem
than men, potentially due to androgen-driven differences in enzyme expression.
- A preclinical study showed that castrated male rats exhibited zolpidem
pharmacokinetics similar to that of female rats, providing further evidence to
suggest that zolpidem pharmacokinetics are androgen-driven.
Objectives:
-To evaluate the effect of castration on the pharmacokinetics of a single 5-mg dose of
zolpidem in participants with prostate cancer undergoing androgen deprivation therapy
(previous post-castration therapy) compared to normal healthy females.
Eligibility:
- Participants with prostate cancer (rising prostate-specific antigen (PSA) and
greater than or equal to 100 ng/dL)
- Females in good health condition or without significant diseases
- After androgen deprivation therapy, castrate testosterone levels <50 ng/dL
- Eastern Cooperative Oncology Group (ECOG) 0-1
Design:
- Comparative, single-dose pharmacokinetic study.
- Men with prostate cancer (pre-castration) and normal healthy females will receive
treatment with a single dose of 5 mg tablet of zolpidem followed by 8-hour
pharmacokinetic evaluation of zolpidem and its metabolites.
- Men will then undergo androgen deprivation therapy and when castrate testosterone
levels <50 ng/dL (post-castration), they will receive another 5 mg single dose of
zolpidem followed by 8-hour pharmacokinetic evaluation of zolpidem and its
metabolites.
- Normal healthy females will receive treatment with a single dose of 5 mg tablet of
zolpidem followed by 8-hour pharmacokinetic evaluation of zolpidem and its
metabolites.
Lead OrganizationNational Cancer Institute
Principal InvestigatorWilliam Douglas Figg
