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Neurokinin Antagonist

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

Phase 1 & 2
Waitlist Available
Led By Jennifer Boston, MSN, APNP
Research Sponsored by Acer Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 14

Summary

This trial is testing a new drug called ACER-801 on postmenopausal women who have severe hot flashes. The drug works by targeting brain receptors to help manage body temperature changes caused by menopause. Participants will receive the drug.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Accumulation Ratio for AUC (ARauc) of ACER-801
Accumulation Ratio for AUC (ARauc) of ACER-801 Metabolite
Accumulation Ratio for Cmax (ARcmax) of ACER-801
+23 more
Secondary study objectives
Change in Frequency Vasomotor Symptoms (Hot Flashes) From Baseline
Change in Frequency of Vasomotor Symptoms (Hot Flashes) From Baseline
Change in Hot Flash Severity Score Vasomotor Symptoms From Baseline
+2 more

Side effects data

From 2023 Phase 1 & 2 trial • 49 Patients • NCT05325775
17%
Vessel puncture site pain
17%
Medical device site reaction
8%
constipation
8%
headache
8%
diarrhoea
8%
neck pain
8%
nasal congestion
8%
cough
8%
syncope
8%
dizziness
8%
sensation of foreign body
8%
back pain
8%
palpitations
8%
vessel puncture site swelling
8%
nasal dryness
100%
80%
60%
40%
20%
0%
Study treatment Arm
ACER-801 50 mg BID
ACER-801 100 mg BID
Placebo
ACER-801 200 mg BID

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: ACER-801 50 mg BIDExperimental Treatment1 Intervention
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
Group II: ACER-801 200 mg BIDExperimental Treatment1 Intervention
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
Group III: ACER-801 100 mg BIDExperimental Treatment1 Intervention
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
Group IV: PlaceboPlacebo Group1 Intervention
Placebo (4 x Placebo of ACER-801 twice daily)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ACER-801 50 mg BID
2022
Completed Phase 2
~50
ACER-801 100 mg BID
2022
Completed Phase 2
~50
ACER-801 200 mg BID
2022
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Acer Therapeutics Inc.Lead Sponsor
2 Previous Clinical Trials
174 Total Patients Enrolled
Jennifer Boston, MSN, APNPPrincipal InvestigatorSpaulding Clinical Research LLC
2 Previous Clinical Trials
206 Total Patients Enrolled
~13 spots leftby Dec 2025
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