NCT05325775

Dose-ranging, PK, Safety, Efficacy Study of Osanetant in Patients With Moderate/Severe VMS Associated With Menopause

A Phase 2A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of ACER-801 for Treatment of Moderate to Severe Vasomotor Symptoms (VMS) Associated With Menopause

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Acer Therapeutics Inc. · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

In this clinical research study, subjects will be given the study drug, ACER-801 (osanetant) or placebo (looks like the study drug but contains no active ingredients). The study drug works on a receptor in the brain and the intended purpose is for the study treatment of moderate to severe Vasomotor Symptoms (VMS) also referred to as hot flashes or flushes associated with menopause. Hot flashes are a change in your temperature that occurs due to changes in your hormones.

Detailed description

This is a Phase 2a, randomized, double-blind, placebo-controlled, dose-ranging study in post menopausal women in which the pharmacokinetics, safety and efficacy of ACER-801 (osanetant 50 mg twice daily \[BID\], 100 mg BID, and 200 mg BID) will be compared to placebo. Subjects will enter a Screening Period to determine eligibility. Subjects will be required to complete hot flash diaries for 2 weeks prior to randomization. Eligible subjects will be admitted to a Clinical Research Unit and remain in the clinic for 14 days after completion of treatment and all study assessments. The study includes a 14 day safety follow-up assessment. Subjects will be randomized in a 1:1:1:1 ratio.

Conditions

• Post-menopausal Vasomotor Symptoms

Interventions

Type	Name	Description
DRUG	ACER-801 50 mg BID	50 mg BID (twice daily)
DRUG	ACER-801 100 mg BID	100 mg BID (twice daily)
DRUG	ACER-801 200 mg BID	200 mg BID (twice daily)
DRUG	Placebo	Placebo

Timeline

• Start date: 2022-03-30
• Primary completion: 2023-03-04
• Completion: 2023-03-04
• First posted: 2022-04-13
• Last updated: 2024-08-07
• Results posted: 2024-08-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study