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

Acer Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Post-menopausal Vasomotor Symptoms

Treatments: Drug: ACER-801 100 mg BID; Drug: ACER-801 50 mg BID; Drug: ACER-801 200 mg BID; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05325775

ACER-801-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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49 participants in 4 patient groups, including a placebo group

ACER-801 50 mg BID

Experimental group

Description:

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

Treatment:

Drug: ACER-801 50 mg BID

ACER-801 100 mg BID

Experimental group

Description:

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

Treatment:

Drug: ACER-801 100 mg BID

ACER-801 200 mg BID

Experimental group

Description:

ACER-801 (osanetant) 200 mg BID (3 x 50 mg and 1 x placebo, twice daily)

Treatment:

Drug: ACER-801 200 mg BID

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo