FP-101 for Hot Flashes

No longer recruiting at 11 trial locations

Overseen By Giovanni Ciavarra, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Fervent Pharmaceuticals

Must not be taking: Antidepressants, Antipsychotics, Opioids, others

Disqualifiers: Pregnancy, Hormone therapy, Cardiac disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the safety and effectiveness of FP-101, an extended-release tablet, in reducing moderate-to-severe hot flashes in peri- and post-menopausal women. Participants will receive either the FP-101 tablet or a placebo (a look-alike tablet with no active ingredient) for one week. Women who experience at least 7-8 hot flashes per day and are not on hormone therapy or certain other medications may be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important early-stage findings.

Do I need to stop my current medications to join the trial?

Yes, you will need to stop taking certain medications, including hormone therapy, antidepressants, and some supplements. The trial has specific exclusions for these and other medications.

Is there any evidence suggesting that FP-101 is likely to be safe for humans?

Research has shown that FP-101 is being tested for safety in treating hot flashes in menopausal women. Since it is in a Phase 2 trial, it has already passed initial safety tests in humans. This phase evaluates how well participants tolerate the treatment and identifies any side effects.

Although specific safety results for FP-101 are not yet available, reaching this phase suggests that initial results were promising. Participants report any side effects, and researchers monitor their frequency and severity.

If earlier studies had found FP-101 harmful, it would not have advanced to this phase. While more detailed information will emerge as the study progresses, this stage indicates a positive sign for safety so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for menopausal vasomotor symptoms, which often include hormone replacement therapies or non-hormonal options like SSRIs and SNRIs, FP-101 is unique because it uses an extended-release formulation. This design allows for a steady release of the active ingredient, potentially providing more consistent symptom relief throughout the day. Researchers are excited about FP-101 because it may offer fewer side effects and a better safety profile compared to traditional hormone-based therapies, making it an appealing alternative for those who cannot or prefer not to use hormones.

What evidence suggests that FP-101 might be an effective treatment for hot flashes?

Research has shown that FP-101, which participants in this trial may receive, may help with moderate-to-severe hot flashes in women experiencing menopause or post-menopause. An initial study found FP-101 to be 90% effective in reducing the frequency of hot flashes. This suggests the treatment could effectively manage these symptoms. Ongoing studies, including this trial, are expected to yield similar results, supporting FP-101 as a promising option for those dealing with hot flashes during menopause. ^{6 7 8 9 10}

Who Is on the Research Team?

Helmut H Albrecht, MD

Principal Investigator

Lumanity

Are You a Good Fit for This Trial?

Inclusion Criteria

Able/willing to provide informed consent.

Able/willing to complete all study procedures and visits.

You must avoid using certain cough and cold medications that have the same ingredients as the study drug.

Exclusion Criteria

Subject exhibits positive home pregnancy test at screening or any time during study

Subject currently taking any form of Hormone Therapy (HT), including local estrogen therapies

Subject currently taking tamoxifen, other selective estrogen receptor modulators, or other hormone deprivation therapy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Telehealth baseline visit

Run-in

1-week run-in period to identify/eliminate placebo responders and exclude subjects with difficulty completing the eDiary

1 week

Telehealth baseline visit

Treatment

Participants receive FP-101 or placebo and complete a daily eDiary to record AEs and hot flash frequency and severity

1 week

Daily virtual interactions via eDiary

Follow-up

End-of-study visit to review safety and efficacy data, complete a Patient Global Improvement Scale, and clarify any open issues

End-of-study telehealth visit

What Are the Treatments Tested in This Trial?

Interventions

• FP-101

How Is the Trial Designed?

Group I: Active Treatment (FP-101) Experimental Treatment 1 Intervention

White to off-white extended-release, round tablets containing FP-101.

Group II: Matching placebo Placebo Group 1 Intervention

White to off-white round tablets without the active ingredient but otherwise matching in size and appearance.

Who Is Running the Clinical Trial?

Fervent Pharmaceuticals

Lead Sponsor

Trials

2

Recruited

210+

ICON plc

Industry Sponsor

Trials

88

Recruited

28,900+

Dr. Steve Cutler

ICON plc

Chief Executive Officer since 2017

PhD from the University of Sydney, MBA from the University of Birmingham

Dr. Greg Licholai

ICON plc

Chief Medical Officer since 2023

Degrees from Harvard Business School, Yale School of Medicine, Columbia University, and Boston College

Published Research Related to This Trial

A study analyzing 1,164 cases of hypoglycemia linked to glucagon-like peptide-1 receptor agonists (GLP-1RAs) found that lixisenatide had the strongest association with hypoglycemia, indicating a need for caution when prescribing this medication.

The median onset time for hypoglycemia after starting GLP-1RA treatment was 5 days, with a notable hospitalization rate of 56.08% and a fatality rate of 3.53%, highlighting the potential risks associated with these drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoglycemia following the use of glucagon-like peptide-1 receptor agonists: a real-world analysis of post-marketing surveillance data. Zhao, Z., Tang, Y., Hu, Y., et al.[2022]

The recent fatal adverse event in the BIA-102474-101 clinical trial highlights significant limitations in the current safety review process for first-into-human trials, despite previous trials with similar compounds being conducted without incident.

To improve safety in future trials, it is crucial to implement sequential dosing strategies, thorough reviews of preclinical toxicity studies, and systematic risk assessments, especially for novel compounds that may pose higher risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implications of the BIA-102474-101 study for review of first-into-human clinical trials. Eddleston, M., Cohen, AF., Webb, DJ.[2021]

The first-in-human clinical trial of BIA 10-2474 resulted in serious adverse events for 6 healthy volunteers, including 1 death, highlighting the heightened risks associated with novel investigational drugs transitioning from animal studies to human trials.

The symposium emphasized the need for careful planning and communication in clinical trials to minimize risks to participants, suggesting that a complex matrix of factors must be considered to ensure safety and integrity in first-in-human studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety in FIH Trials: A Summary of the Symposium "Fatal Drug Trial in Phase 1: Understanding Risk, Subject Safety, Timelines, and Cost". Greenberg, HE., van Iersel, MT., Westrick, ML., et al.[2020]

In a review of 24 First-in-Man studies involving 1,017 healthy male volunteers, the incidence of adverse events (AEs) was low, with 98.3% of AEs being mild or moderate, indicating a favorable safety profile for small molecules in Phase I trials.

Only 0.4% of treatments resulted in serious adverse events, all of which were not medically concerning and did not require hospitalization, suggesting that small molecule trials can be conducted safely in healthy volunteers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of healthy volunteers in First-in-Man trials - an analysis of studies conducted at the Bayer in-house ward from 2000 to 2005. Wensing, G., Ighrayeb, IA., Boix, O., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05312567?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Fervent%20Pharmaceuticals%22)&viewType=Table&rank=2

FP-101 Versus Placebo in the Treatment of Menopausal ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03285672?term=AREA%5BSponsorSearch%5D(COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Fervent%20Pharmaceuticals%22))&rank=1

NCT03285672 | FP-101 for the Treatment of Hot Flashes in ... The primary efficacy endpoint for the main study is the change in the frequency of moderate-to-severe hot flashes. Baseline to Week 8. Secondary Outcome ...

3. ferventpharma.com ferventpharma.com/fervent-pharmaceuticals-completes-clinical-trial-for-promising-new-post-menopausal-therapy-treating-vasomotor-symptoms/

Fervent Pharmaceuticals Completes Clinical Trial For ... FP-101 demonstrated a 90% efficacy rate in its pilot study, and Fervent expects similar results to emerge from the clinical trial when the data has been ...

4. greenclimate.fund greenclimate.fund/document/interim-evaluation-report-fp101-resilient-rural-belize-be-resilient

Interim evaluation report for FP101: Resilient Rural Belize ... It examines performance against the project's logical framework, implementation plan and GCF investment criteria, including efficiency, effectiveness, ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.6012

Safety and efficacy of immune checkpoint inhibitor (ICI) ... The estimated 12-month OS of 87.1% is promising compared to published results of about 36-50%. These results justify a confirmatory randomized, ...

6. canderentals.com canderentals.com/galleryupload/webdoc/sds%20sheets/DUPLICOLOR%20AUTOMOTIVE%20PRIMER%20FILLER%20SDS.pdf

SAFETY DATA SHEET FP101. DUPLI-COLOR® Filler Primer. Gray. SHW-85-NA-GHS-US. Page 2 ... It is recommended that each customer or recipient of this Safety Data Sheet ...

7. bettymills.com bettymills.com/product/MSDS/FRS%201215.pdf?srsltid=AfmBOookgEg25ey5km2xxCpWdcbnimkUbWBwASTRw164N8q-NCLlH3Ba

FP#101 Wick Material Safety Data Sheet FP#101 Wick. Material Safety Data Sheet. -Section 1. Chemical Product & Company Information. Emergency Contact: (Spill/Release) [phone].

8. evrogen.com evrogen.com/MSDS.php?cat=FP101-d

SAFETY DATA SHEET This safety datasheet complies with the requirements of Regulation (EC) No. 1907/2006. Page 5. Evrogen – Cat.#FP101. pAce-Green-C1.

9. paintdocs.com paintdocs.com/docs/webPDF.jsp?SITEID=DUPLI&lang=2&cntry=US&doctype=SDS&prodno=026916321015

P@44501_SHW-85-NA-GHS Prevention. : Obtain special instructions before use. Do not handle until all safety precautions have been read and understood.

10. fdneurotech.com fdneurotech.com/docs/1334070944.msds-pf101-2012-1.pdf

Material Safety Data Sheet - FD NeuroTechnologies Harmful by inhalation, skin, or eye contact. May be toxic if swallowed. Wear gloves and glasses. Avoid inhalation. Wash hands after handling. ...