Phase 2
N=49
Dose-ranging, PK, Safety, Efficacy Study of Osanetant in Patients With Moderate/Severe VMS Associated With Menopause
Post-menopausal Vasomotor Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT05325775 ↗Enrolled (actual)
49
Serious AEs
2.0%
Results posted
Aug 2024
Primary outcome: Primary: Peak Plasma Concentration (Cmax) of ACER-801 — 10.78; 32.36; 41.75 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ACER-801 50 mg BID (Drug); ACER-801 100 mg BID (Drug); ACER-801 200 mg BID (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Acer Therapeutics Inc.
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Plasma Concentration (Cmax) of ACER-801 |
27.47; 83.08; 168.28 | — |
| PRIMARY Peak Plasma Concentration (Cmax) of ACER-801 |
27.47; 83.08; 168.28 | — |
| PRIMARY Peak Plasma Concentration (Cmax) of ACER-801 Metabolite |
38.79; 92.17; 196.80 | — |
| PRIMARY Peak Plasma Concentration (Cmax) of ACER-801 Metabolite |
38.79; 92.17; 196.80 | — |
| PRIMARY Time to Reach Maximum Concentration (Tmax) of ACER-801 |
0.96; 2.17; 1.79 | — |
| PRIMARY Time to Reach Maximum Concentration (Tmax) of ACER-801 |
0.96; 2.17; 1.79 | — |
| PRIMARY Time to Reach Maximum Concentration (Tmax) of ACER-801 Metabolite |
1.21; 2.21; 1.88 | — |
| PRIMARY Time to Reach Maximum Concentration (Tmax) of ACER-801 Metabolite |
1.21; 2.21; 1.88 | — |
| PRIMARY Area Under the Concentration Curve From Dosing to the Time of the Last Measured Concentration (AUClast) of ACER-801 |
174.72; 517.91; 1252.54 | — |
| PRIMARY Area Under the Concentration Curve From Dosing to the Time of the Last Measured Concentration (AUClast) of ACER-801 |
174.72; 517.91; 1252.54 | — |
| PRIMARY Area Under the Concentration Curve From Dosing to the Time of the Last Measured Concentration (AUClast) of ACER-801 Metabolite |
257.56; 628.87; 1579.25 | — |
| PRIMARY Area Under the Concentration Curve From Dosing to the Time of the Last Measured Concentration (AUClast) of ACER-801 Metabolite |
257.56; 628.87; 1579.25 | — |
| PRIMARY Half-life (T1/2) of ACER-801 |
5.75; 5.06; 5.56 | — |
| PRIMARY Half-life (T1/2) of ACER-801 |
5.75; 5.06; 5.56 | — |
| PRIMARY Half-life (T1/2) of ACER-801 Metabolite |
6.55; 5.57; 5.99 | — |
| PRIMARY Half-life (T1/2) of ACER-801 Metabolite |
6.55; 5.57; 5.99 | — |
| PRIMARY Number and Percentage of Adverse Events ≥ 5% |
17; 21; 23; 21 | — |
| PRIMARY Number and Percentage of Serious Adverse Events (SAE) |
0; 0; 1; 0 | — |
| PRIMARY Number and Percentage of Subjects Who Discontinued From the Study |
0; 0; 0; 0 | — |
| PRIMARY Number of Patients With a Clinically Significant Change From Baseline in Abnormalities Detected During Physical Examination |
0; 0; 0; 0 | — |
| PRIMARY Accumulation Ratio for Cmax (ARcmax) of ACER-801 |
4.87; 4.38; 4.76 | — |
| PRIMARY Accumulation Ratio for AUC (ARauc) of ACER-801 |
7.76; 6.15; 7.16 | — |
| PRIMARY Accumulation Ratio for Cmax (ARcmax) of ACER-801 Metabolite |
4.28; 2.70; 3.51 | — |
| PRIMARY Accumulation Ratio for AUC (ARauc) of ACER-801 Metabolite |
5.99; 5.11; 6.22 | — |
| PRIMARY Metabolite: Parent Ratio of AUC (MRauc) |
1.65; 1.23; 1.31 | — |
| PRIMARY Metabolite: Parent Ratio of AUC (MRauc) |
1.65; 1.23; 1.31 | — |
| PRIMARY Metabolite:Parent Ratio of Cmax (MRcmax) |
1.55; 1.15; 1.23 | — |
| PRIMARY Metabolite:Parent Ratio of Cmax (MRcmax) |
1.55; 1.15; 1.23 | — |
| PRIMARY Area Under the Concentration Curve From t0 to Infinite Time (AUCinf) of ACER-801 |
231.48; 682.25; 1673.06 | — |
| PRIMARY Area Under the Concentration Curve From t0 to Infinite Time (AUCinf) of ACER-801 |
231.48; 682.25; 1673.06 | — |
| PRIMARY Area Under the Concentration Curve From t0 to Infinite Time (AUCinf) of ACER-801 Metabolite |
380.43; 819.29; 2270.60 | — |
| PRIMARY Area Under the Concentration Curve From t0 to Infinite Time (AUCinf) of ACER-801 Metabolite |
380.43; 819.29; 2270.60 | — |
| PRIMARY Number of Subjects With a Clinically Significant Change From Baseline for Clinical Laboratory Evaluations: HEMATOLOGY |
0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With a Clinically Significant Change From Baseline for Clinical Laboratory Evaluations: SERUM CHEMISTRY |
0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With a Clinically Significant Change From Baseline for Clinical Laboratory Evaluations: COAGULATION |
0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With a Clinically Significant Change From Baseline for Clinical Laboratory Evaluations: URINALYSIS |
0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With a Clinically Significant Change From Baseline for Clinical Laboratory Evaluations: BONE DENSITY MARKERS |
— | — |
| PRIMARY Number of Subjects With a Clinically Significant Change From Baseline for Clinical Laboratory Evaluations: HORMONES |
— | — |
| SECONDARY Change in Frequency of Vasomotor Symptoms (Hot Flashes) From Baseline |
-2.58; -2.81; -3.60; -3.39 | — |
| SECONDARY Change in Frequency Vasomotor Symptoms (Hot Flashes) From Baseline |
-3.30; -5.02; -5.15; -5.62 | — |
| SECONDARY Change in Severity of Vasomotor Symptoms (Hot Flashes) From Baseline |
-0.31; -0.32; -0.43; -0.37 | — |
| SECONDARY Change in Severity of Vasomotor Symptoms (Hot Flashes) From Baseline |
-0.31; -0.32; -0.43; -0.37 | — |
| SECONDARY Change in Hot Flash Severity Score Vasomotor Symptoms From Baseline |
-6.09; -7.45; -8.10; -8.56 | — |
| SECONDARY Change in Hot Flash Severity Score of Vasomotor Symptoms From Baseline |
-7.52; -12.47; -11.95; -13.67 | — |
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.
Eligibility Criteria
Key Inclusion Criteria
- Post-menopausal female subjects 40-65 years of age, inclusive.
Menopause will be defined as:
- 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 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.
- Subjects who, in the opinion of the investigator, should not participate in the study for any other reason.
Data sourced from ClinicalTrials.gov (NCT05325775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.