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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-30

Study Completion Date

2023-03-04

Brief Summary

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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.

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Detailed Description

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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

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Post-menopausal Vasomotor Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomized in a 1:1:1:1 ratio to ACER-801 per one of the following dosing schedules prior to dosing:

* 50 mg BID,
* 100 mg BID,
* 200 mg BID, or
* Placebo BID

Each arm is administered orally for 14 consecutive days (28 doses).

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The patient, the Investigator, and other members of the staff involved with the study will remain blinded to study treatment.

Study Groups

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ACER-801 50 mg BID

ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)

Group Type EXPERIMENTAL

ACER-801 50 mg BID

Intervention Type DRUG

50 mg BID (twice daily)

ACER-801 100 mg BID

ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)

Group Type EXPERIMENTAL

ACER-801 100 mg BID

Intervention Type DRUG

100 mg BID (twice daily)

ACER-801 200 mg BID

ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)

Group Type EXPERIMENTAL

ACER-801 200 mg BID

Intervention Type DRUG

200 mg BID (twice daily)

Placebo

Placebo (4 x Placebo of ACER-801 twice daily)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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ACER-801 50 mg BID

50 mg BID (twice daily)

Intervention Type DRUG

ACER-801 100 mg BID

100 mg BID (twice daily)

Intervention Type DRUG

ACER-801 200 mg BID

200 mg BID (twice daily)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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osanetant osanetant osanetant Placebo of ACER-801

Eligibility Criteria

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Inclusion Criteria

1. Post-menopausal female subjects 40-65 years of age, inclusive.

Menopause will be defined as:
1. At least 12 months of spontaneous, continuous amenorrhea, or
2. At least 6 months of spontaneous, continuous amenorrhea with serum follicle stimulating hormone (FSH) levels \> 40 mIU/mL at screening, or
3. At least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
2. At baseline women:

1. With an average number of moderate to severe hot flashes/day for 2 weeks prior to randomization (per continuous hot flash diary).
2. That have a change of \< 50% in average 24-hour hot flash frequency 2 weeks prior to randomization.

* Moderate: defined as sensation of heat with sweating, able to continue activity.
* Severe: defined as sensation of heat with sweating, causing cessation of activity.

Exclusion Criteria

1. Any active comorbid disease deemed by the investigator to be clinically significant, which could impact safety during study conduct including renal or hepatic impairment.
2. Use of any prohibited medications.
3. Body mass index (BMI) \>35 kg/m2.
4. Any active ongoing condition that could cause difficulty in interpreting vasomotor symptoms.
5. Inability to complete questionnaires and continuous hot flash diary for any reason.
6. Subjects who, in the opinion of the investigator, should not participate in the study for any other reason.

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No