FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor Symptoms

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

105 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a slow-release pill called FP-101 to help women over 45 who suffer from severe hot flashes during menopause. The pill aims to reduce the frequency and severity of these hot flashes by releasing its medicine gradually.

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.

What safety data exists for the treatment known as FP-101?

The safety of treatments in early human trials can vary, as seen in the BIA-102474-101 study where serious adverse events occurred despite prior safety reviews. This highlights the importance of careful planning and monitoring in first-in-human trials to ensure participant safety. ^{1 2 3 4 5}

Research Team

Helmut H Albrecht, MD

Principal Investigator

Lumanity

Eligibility Criteria

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

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

Treatment Details

Interventions

• FP-101

Participant Groups

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

Findings from Research

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 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]

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]

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]

References

1. China 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. [2022]

2. Switzerland 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". [2020]

3. England pubmed.ncbi.nlm.nih.gov

Implications of the BIA-102474-101 study for review of first-into-human clinical trials. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Trends in safety pharmacology: posters presented at the annual meetings of the Safety Pharmacology Society 2001-2010. [2013]

5. Germany 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. [2019]