Zolpidem Pharmacokinetics in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy

Overseen By William D Figg, Pharm.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: Sedative hypnotics, CYP3A4 drugs

Disqualifiers: Cardiac disease, Hepatitis, Psychiatric issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the sleep medication zolpidem (Ambien) behaves in the bodies of men with prostate cancer undergoing hormone therapy compared to healthy women. Researchers are examining how prostate cancer treatments might alter zolpidem levels, which could help determine the best dose for different groups. Men with prostate cancer starting androgen deprivation therapy, as well as healthy women, may be suitable candidates for this study. Participants will take zolpidem and undergo tests to track how their bodies process the drug. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to foundational knowledge.

Will I have to stop taking my current medications?

The trial requires that participants stop taking certain medications. Male participants cannot take medications that affect zolpidem metabolism, like strong CYP3A4 inhibitors or inducers. Female participants must not be on regular medications, except contraceptives, within two weeks before the study.

Is there any evidence suggesting that zolpidem is likely to be safe for humans?

Research has shown that zolpidem, also known as Ambien, is usually safe for use. Studies indicate it rarely causes serious side effects, and most people taking zolpidem do not experience major problems. Some might feel mild effects like dizziness or drowsiness. Zolpidem is already FDA-approved for treating insomnia, indicating its safety for this purpose. If any side effects occur during the trial, researchers will closely monitor participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using zolpidem in prostate cancer patients undergoing androgen deprivation therapy (ADT) because it explores a unique interaction between sleep aids and cancer treatment. Unlike typical treatments for prostate cancer, which primarily focus on hormone suppression, this study looks at zolpidem, a well-known sleep medication, to see how it behaves in the body before and after ADT. This could lead to better management of sleep issues in cancer patients, potentially improving their quality of life during treatment. By understanding zolpidem's pharmacokinetics in this context, researchers hope to tailor sleep aid regimens specifically for prostate cancer patients on ADT.

What evidence suggests that zolpidem might be an effective treatment for insomnia in prostate cancer patients undergoing androgen deprivation therapy?

Studies have shown that zolpidem helps adults fall asleep and stay asleep. In individuals with solid tumors, such as prostate cancer, zolpidem has improved sleep quality. This medication acts as a strong sedative, promoting relaxation and better sleep. The trial focuses on understanding zolpidem's effects in the body, particularly when prostate cancer treatment reduces male hormone levels. Participants will receive zolpidem either as a single 5 mg oral dose or in a regimen before and after undergoing androgen deprivation therapy. Research suggests that women may have higher levels of zolpidem in their system after taking it, potentially affecting how they feel the next day. ^{1 2 3 6 7}

Who Is on the Research Team?

William D Figg, Pharm.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

Men over 18 with prostate cancer planning to undergo androgen deprivation therapy, and healthy women over 18 can join. Participants must have normal organ function, not be on certain medications or have other cancers, serious illnesses, or psychiatric conditions that could affect the study.

Inclusion Criteria

Willingness to travel to NIH for follow-up visits.

I haven't had any other cancers except for non-dangerous skin cancer or very early stage leukemia in the last 2 years.

Ability of subject to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

I do not have any serious illnesses that would stop me from following the study's requirements.

I do not have severe heart problems or recent heart attacks.

I have no liver, stomach, or other conditions affecting medication processing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment - Pre-ADT

Participants receive a single 5 mg dose of zolpidem followed by an 8-hour pharmacokinetic evaluation

1 day

Overnight stay

Treatment - Post-ADT

After undergoing androgen deprivation therapy and reaching castrate testosterone levels, participants receive another 5 mg dose of zolpidem followed by an 8-hour pharmacokinetic evaluation

1 day

Overnight stay

Follow-up

Participants receive a follow-up phone call after each overnight stay to monitor for any adverse events

3 days

What Are the Treatments Tested in This Trial?

Interventions

• Zolpidem

Trial Overview The trial is testing how castration affects the levels of Zolpidem in men with prostate cancer compared to its levels in healthy women. Men will take Zolpidem before and after their testosterone-lowering treatment; both groups will stay overnight for monitoring.

How Is the Trial Designed?

Group I: Zolpidem pre and post castration Experimental Treatment 2 Interventions

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

Group II: Female Active Control 2 Interventions

Single 5 mg oral dose of zolpidem

Zolpidem is already approved in United States, European Union for the following indications:

Approved in United States as Ambien for:

• Insomnia
• Limited use in central sleep apnea syndromes under strict conditions

Approved in European Union as Zolpidem for:

• Insomnia
• Not specifically approved for central sleep apnea but may be considered off-label

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03436745

Study Details | NCT03436745 | The Effects of Castration on ... Objectives: -To evaluate the effect of castration on the pharmacokinetics of a single 5-mg dose of zolpidem in participants with prostate cancer undergoing ...

2. withpower.com withpower.com/trial/phase-1-prostatic-neoplasms-2019-1ce30

Zolpidem Pharmacokinetics in Prostate Cancer Patients ... Zolpidem is effective in helping adults fall and stay asleep, as shown in studies where it improved sleep in solid tumor patients. It is a strong sedative that ...

3. trialx.com trialx.com/clinical-trials/listings/274412/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/

The Effects of Castration on the Pharmacokinetics ... Men with prostate cancer (pre-castration) and normal healthy females will receive treatment with a single dose of 5 mg tablet of zolpidem ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2018-03652

The Effects of Castration on the Pharmacokinetics ... 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 ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/45/NCT03436745/Prot_SAP_000.pdf

Castration on Zolpidem PK Version Date: 02/08/2022 This is single-dose, comparative trial evaluating the effect of castration on the pharmacokinetics of a single 5-mg dose of zolpidem in participants with ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03436745?tab=table

The Effects of Castration on the Pharmacokinetics of Zolpidem ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3498427/

Relationship of Zolpidem and Cancer Risk: A Taiwanese ... Our results demonstrate that zolpidem users have a significantly higher rate of subsequent oral and liver cancer development but not cervical cancer. One ...