CompletedPhase 1/2

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

United States49 participantsStarted 2022-03-30

Plain-language 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.

Who can participate

Age range40 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Post-menopausal female subjects 40-65 years of age, inclusive.
✓. At least 12 months of spontaneous, continuous amenorrhea, or
✓. At least 6 months of spontaneous, continuous amenorrhea with serum follicle stimulating hormone (FSH) levels \> 40 mIU/mL at screening, or
✓. At least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
✓. At baseline women:
✓. With an average number of moderate to severe hot flashes/day for 2 weeks prior to randomization (per continuous hot flash diary).
✓. That have a change of \< 50% in average 24-hour hot flash frequency 2 weeks prior to randomization.

Exclusion criteria

✕. Any active comorbid disease deemed by the investigator to be clinically significant, which could impact safety during study conduct including renal or hepatic impairment.
✕. Use of any prohibited medications.
✕. Body mass index (BMI) \>35 kg/m2.
✕. Any active ongoing condition that could cause difficulty in interpreting vasomotor symptoms.
✕. Inability to complete questionnaires and continuous hot flash diary for any reason.
✕

What they're measuring

Peak Plasma Concentration (Cmax) of ACER-801

Timeframe: Day 1

Peak Plasma Concentration (Cmax) of ACER-801

Timeframe: Day 14

Peak Plasma Concentration (Cmax) of ACER-801 Metabolite

Timeframe: Day 1

Peak Plasma Concentration (Cmax) of ACER-801 Metabolite

Timeframe: Day 14

Time to Reach Maximum Concentration (Tmax) of ACER-801

Timeframe: Day 1

Time to Reach Maximum Concentration (Tmax) of ACER-801

Timeframe: Day 14

Time to Reach Maximum Concentration (Tmax) of ACER-801 Metabolite

Timeframe: Day 1

Time to Reach Maximum Concentration (Tmax) of ACER-801 Metabolite

Timeframe: Day 14

Trial details

NCT IDNCT05325775

SponsorAcer Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-04

Results submitted2024-03-03

View on ClinicalTrials.gov More Post-menopausal Vasomotor Symptoms trials

Plain-language summary

Who can participate

Age range40 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Post-menopausal female subjects 40-65 years of age, inclusive.
✓. At least 12 months of spontaneous, continuous amenorrhea, or
✓. At least 6 months of spontaneous, continuous amenorrhea with serum follicle stimulating hormone (FSH) levels \> 40 mIU/mL at screening, or
✓. At least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
✓. At baseline women:
✓. With an average number of moderate to severe hot flashes/day for 2 weeks prior to randomization (per continuous hot flash diary).
✓. That have a change of \< 50% in average 24-hour hot flash frequency 2 weeks prior to randomization.

Exclusion criteria

✕. Any active comorbid disease deemed by the investigator to be clinically significant, which could impact safety during study conduct including renal or hepatic impairment.
✕. Use of any prohibited medications.
✕. Body mass index (BMI) \>35 kg/m2.
✕. Any active ongoing condition that could cause difficulty in interpreting vasomotor symptoms.
✕. Inability to complete questionnaires and continuous hot flash diary for any reason.
✕

What they're measuring

Peak Plasma Concentration (Cmax) of ACER-801

Timeframe: Day 1

Peak Plasma Concentration (Cmax) of ACER-801

Timeframe: Day 14

Peak Plasma Concentration (Cmax) of ACER-801 Metabolite

Timeframe: Day 1

Peak Plasma Concentration (Cmax) of ACER-801 Metabolite

Timeframe: Day 14

Time to Reach Maximum Concentration (Tmax) of ACER-801

Timeframe: Day 1

Time to Reach Maximum Concentration (Tmax) of ACER-801

Timeframe: Day 14

Time to Reach Maximum Concentration (Tmax) of ACER-801 Metabolite

Timeframe: Day 1

Time to Reach Maximum Concentration (Tmax) of ACER-801 Metabolite

Timeframe: Day 14