Post-menopausal Vasomotor SymptomsPhase 1/2NCT05325775
Dose-ranging, PK, Safety, Efficacy Study of Osanetant in Patients With Moderate/Severe VMS Associated With Menopause
A Phase 1/2 study testing ACER-801 50 mg BID, ACER-801 100 mg BID and ACER-801 200 mg BID in people with Post-menopausal Vasomotor Symptoms, run by Acer Therapeutics Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Post-menopausal Vasomotor Symptoms
- What is being tested?
- ACER-801 50 mg BID, ACER-801 100 mg BID and ACER-801 200 mg BID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2022to 4 Mar 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
- Moderate: defined as sensation of heat with sweating, able to continue activity.
- Severe: defined as sensation of heat with sweating, causing cessation of activity.
Who cannot join
- 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.
- Subjects who, in the opinion of the investigator, should not participate in the study for any other reason.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Clinical Research
West Bend, Wisconsin, 53095
About this study
Official title: A Phase 2A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of ACER-801 for Treatment of Moderate to Severe Vasomotor Symptoms (VMS) Associated With Menopause
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.
Read the detailed 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.
- Conditions
- Post-menopausal Vasomotor Symptoms
- Being tested
- ACER-801 50 mg BID, ACER-801 100 mg BID, ACER-801 200 mg BID, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACER-801 50 mg BIDDrug
Also called osanetant
50 mg BID (twice daily)
ACER-801 100 mg BIDDrug
Also called osanetant
100 mg BID (twice daily)
ACER-801 200 mg BIDDrug
Also called osanetant
200 mg BID (twice daily)
PlaceboDrug
Also called Placebo of ACER-801
Placebo
| Study group | Role | What they receive |
|---|---|---|
| ACER-801 50 mg BID | Experimental | ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily) Receives: Drug: ACER-801 50 mg BID |
| ACER-801 100 mg BID | Experimental | ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily) Receives: Drug: ACER-801 100 mg BID |
| ACER-801 200 mg BID | Experimental | ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily) Receives: Drug: ACER-801 200 mg BID |
| Placebo | Placebo comparator | Placebo (4 x Placebo of ACER-801 twice daily) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax) of ACER-801
maximum concentration of ACER-801 measured at Day 1
Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Cmax (mean, SD) data are available due to abbreviated data analyses.
Measured: Day 1
Peak Plasma Concentration (Cmax) of ACER-801
maximum concentration of ACER-801 measured at Day 14
Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Cmax (mean, SD) data are available due to abbreviated data analyses.
Measured: Day 14
Peak Plasma Concentration (Cmax) of ACER-801 Metabolite
peak concentration of ACER-801 metabolite measured at Day 1
Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Cmax (mean, SD) data are available due to abbreviated data analyses.
Measured: Day 1
Peak Plasma Concentration (Cmax) of ACER-801 Metabolite
peak concentration of ACER-801 metabolite measured at Day 14
Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Cmax (mean, SD) data are available due to abbreviated data analyses.
Measured: Day 14
Time to Reach Maximum Concentration (Tmax) of ACER-801
time to reach maximum concentration of ACER-801 measured at Day 1
Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Tmax (mean, SD) data are available due to abbreviated data analyses.
Measured: Day 1
Time to Reach Maximum Concentration (Tmax) of ACER-801
time to reach maximum concentration of ACER-801 at Day 14
Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Tmax (mean, SD) data are available due to abbreviated data analyses.
Measured: Day 14
Time to Reach Maximum Concentration (Tmax) of ACER-801 Metabolite
time to reach maximum concentration of ACER-801 metabolite at Day 1
Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Tmax (mean, SD) data are available due to abbreviated data analyses.
Measured: Day 1
Time to Reach Maximum Concentration (Tmax) of ACER-801 Metabolite
Time to reach maximum concentration of ACER-801 metabolite at Day 14
Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Tmax (mean, SD) data are available due to abbreviated data analyses.
Measured: Day 14
Area Under the Concentration Curve From Dosing to the Time of the Last Measured Concentration (AUClast) of ACER-801
Area under the concentration time curve (AUC) from the time of dosing (0 hour) to the time of the last quantifiable (positive) concentration (Tlast) of ACER-801, calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method)
Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only AUClast (mean, SD) data are available due to abbreviated data analyses.
Measured: Day 1
Area Under the Concentration Curve From Dosing to the Time of the Last Measured Concentration (AUClast) of ACER-801
Area under the concentration time curve (AUC) from the time of dosing (0 hour) to the time of the last quantifiable (positive) concentration (Tlast) of ACER-801, calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method)
Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only AUClast (mean, SD) data are available due to abbreviated data analyses.
Measured: Day 14
Area Under the Concentration Curve From Dosing to the Time of the Last Measured Concentration (AUClast) of ACER-801 Metabolite
Area under the concentration time curve (AUC) from the time of dosing (0 hour) to the time of the last quantifiable (positive) concentration (Tlast) of ACER-801 metabolite, calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method)
Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only AUClast (mean, SD) data are available due to abbreviated data analyses.
Measured: Day 1
Area Under the Concentration Curve From Dosing to the Time of the Last Measured Concentration (AUClast) of ACER-801 Metabolite
Area under the concentration time curve (AUC) from the time of dosing (0 hour) to the time of the last quantifiable (positive) concentration (Tlast) of ACER-801 metabolite, calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method)
Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only AUClast (mean, SD) data are available due to abbreviated data analyses.
Measured: Day 14
Half-life (T1/2) of ACER-801
Terminal elimination half-life of ACER-801
Measured: Day 1
Half-life (T1/2) of ACER-801
Terminal elimination half-life of ACER-801
Measured: Day 14
Half-life (T1/2) of ACER-801 Metabolite
Terminal elimination half-life of ACER-801 metabolite
Measured: Day 1
Half-life (T1/2) of ACER-801 Metabolite
Terminal elimination half-life of ACER-801 metabolite
Measured: Day 14
Number and Percentage of Adverse Events ≥ 5%
An Adverse Event (AE) is defined as any untoward medical occurrence associated with the use of the investigational product in humans, whether or not considered related to investigational product. An AE can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with any use of the investigational product, without any judgment about causality and irrespective of route of administration, formulation, or dose, including an overdose.
Measured: 2 weeks
Number and Percentage of Serious Adverse Events (SAE)
An AE is considered "serious" if, in the view of either the investigator or Acer, it results in any of the following outcomes: Death, Is immediately life threatening; Requires in-patient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability or incapacity; Results in a congenital abnormality or birth defect; Is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
Measured: 2 weeks
Number and Percentage of Subjects Who Discontinued From the Study
Discontinuation or withdrawal from the study.
Measured: Over 2 weeks
Number of Patients With a Clinically Significant Change From Baseline in Abnormalities Detected During Physical Examination
A physician or appropriately qualified delegate conducted a full physical examination at baseline and at Day 14. The investigator decides if findings are considered abnormal at baseline and at Day 14 and whether the change is clinically significant. Only clinically significant changes will be reported.
Measured: At Day 14 relative to Baseline
Accumulation Ratio for Cmax (ARcmax) of ACER-801
Cmax (maximum concentration) Accumulation Ratio calculated as Cmax,Day14/ Cmax,Day1 and AUCt,Day14/ AUCt,Day1, where the dosing interval t is 12h.
Measured: Day 14
Accumulation Ratio for AUC (ARauc) of ACER-801
AUC (area under the curve) Accumulation Ratio calculated as Cmax,Day14/ Cmax,Day1 and AUCt,Day14/ AUCt,Day1, where the dosing interval t is 12h.
Measured: Day 14
Accumulation Ratio for Cmax (ARcmax) of ACER-801 Metabolite
Cmax (maximum concentration) Accumulation Ratio calculated as Cmax,Day14/ Cmax,Day1 and AUCt,Day14/ AUCt,Day1, where the dosing interval t is 12h.
Measured: Day 14
Accumulation Ratio for AUC (ARauc) of ACER-801 Metabolite
AUC (area under the curve) Accumulation Ratio calculated as Cmax,Day14/ Cmax,Day1 and AUCt,Day14/ AUCt,Day1, where the dosing interval t is 12h.
Measured: Day 14
Metabolite: Parent Ratio of AUC (MRauc)
MR = Metabolite:Parent Ratio calculated as Cm,day14/ Cp,day1 and AUCt,m,day14/ AUCt,p,day1, where m and p are the metabolite and parent drug, respectively, and t is the dosing interval (12 h).
AUC = area under the curve
Measured: Day 1
Metabolite: Parent Ratio of AUC (MRauc)
AUC (area under the curve) MR = Metabolite:Parent Ratio calculated as Cm,day14/ Cp,day1 and AUCt,m,day14/ AUCt,p,day1, where m and p are the metabolite and parent drug, respectively, and t is the dosing interval (12 h).
Measured: Day 14
Metabolite:Parent Ratio of Cmax (MRcmax)
MR = Metabolite:Parent Ratio calculated as Cm,day14/ Cp,day1 and AUCt,m,day14/ AUCt,p,day1, where m and p are the metabolite and parent drug, respectively, and t is the dosing interval (12 h).
ACER-801 (parent); Cmax (maximum concentration)
Measured: Day 1
Metabolite:Parent Ratio of Cmax (MRcmax)
MR = Metabolite:Parent Ratio calculated as Cm,day14/ Cp,day1 and AUCt,m,day14/ AUCt,p,day1, where m and p are the metabolite and parent drug, respectively, and t is the dosing interval (12 h).
ACER-801 (parent); Cmax (maximum concentration)
Measured: Day 14
Area Under the Concentration Curve From t0 to Infinite Time (AUCinf) of ACER-801
AUC from the time of dosing (0 hour) extrapolated to infinity, calculated as AUClast + Clast/λz, where Clast was the last quantifiable concentration, and λz was the terminal elimination rate constant Reliability of AUCinf values was contingent upon AUCext and λz Profiles with AUCext ≤20% and a λz which met reporting criteria were considered reliable and AUCinf was reported. For profiles that did not meet these criteria, AUCinf and any parameter requiring AUCinf for computation were not reported.
Measured: Day 1
Area Under the Concentration Curve From t0 to Infinite Time (AUCinf) of ACER-801
AUC from the time of dosing (0 hour) extrapolated to infinity, calculated as AUClast + Clast/λz, where Clast was the last quantifiable concentration, and λz was the terminal elimination rate constant Reliability of AUCinf values was contingent upon AUCext and λz Profiles with AUCext ≤20% and a λz which met reporting criteria were considered reliable and AUCinf was reported. For profiles that did not meet these criteria, AUCinf and any parameter requiring AUCinf for computation were not reported.
Measured: Day 14
Area Under the Concentration Curve From t0 to Infinite Time (AUCinf) of ACER-801 Metabolite
AUC from the time of dosing (0 hour) extrapolated to infinity, calculated as AUClast + Clast/λz, where Clast was the last quantifiable concentration, and λz was the terminal elimination rate constant Reliability of AUCinf values was contingent upon AUCext and λz Profiles with AUCext ≤20% and a λz which met reporting criteria were considered reliable and AUCinf was reported. For profiles that did not meet these criteria, AUCinf and any parameter requiring AUCinf for computation were not reported.
Measured: Day 1
Area Under the Concentration Curve From t0 to Infinite Time (AUCinf) of ACER-801 Metabolite
AUC from the time of dosing (0 hour) extrapolated to infinity, calculated as AUClast + Clast/λz, where Clast was the last quantifiable concentration, and λz was the terminal elimination rate constant Reliability of AUCinf values was contingent upon AUCext and λz Profiles with AUCext ≤20% and a λz which met reporting criteria were considered reliable and AUCinf was reported. For profiles that did not meet these criteria, AUCinf and any parameter requiring AUCinf for computation were not reported.
Measured: Day 14
Number of Subjects With a Clinically Significant Change From Baseline for Clinical Laboratory Evaluations: HEMATOLOGY
Blood samples will be measured for hemoglobin, hematocrit, white blood count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), platelet count, red blood cell count (including mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration). Only clinically significant changes will be reported.
Measured: Over 2 weeks
Number of Subjects With a Clinically Significant Change From Baseline for Clinical Laboratory Evaluations: SERUM CHEMISTRY
Blood samples will be measured for albumin, alkaline phosphatase, total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen, calcium, carbon dioxide, chloride, potassium, sodium, total cholesterol, creatinine, gamma glutamyl transferase, glucose, lactate dehydrogenase, phosphorus, total protein, uric acid. Only clinically significant changes will be reported.
Measured: 2 weeks
Number of Subjects With a Clinically Significant Change From Baseline for Clinical Laboratory Evaluations: COAGULATION
Blood samples will be measured for prothrombin time, partial thromboplastin time, international normalized ratio. Only clinically significant changes will be reported.
Measured: 2 weeks
Number of Subjects With a Clinically Significant Change From Baseline for Clinical Laboratory Evaluations: URINALYSIS
Urine samples will be measured for pH, specific gravity, protein, glucose, ketones, bilirubin. Only clinically significant changes will be reported.
Measured: 2 weeks
Number of Subjects With a Clinically Significant Change From Baseline for Clinical Laboratory Evaluations: BONE DENSITY MARKERS
Blood samples not available/collected for testing. Blood samples will be measured for Bone Specific Alkaline Phosphatase (BSAP), osteocalcin, amino terminal propeptide of type 1 collagen (P1NP) and Collagen Type- C-Telopeptide (CTX). Only clinically significant changes will be reported.
Measured: 2 weeks
Number of Subjects With a Clinically Significant Change From Baseline for Clinical Laboratory Evaluations: HORMONES
Blood samples not available/collected for testing. Blood samples will be measured for catecholamines, vasopressin, gonadotropins, estradiol, testosterone, follicle stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), cortisol, thyroid-stimulating hormone (TSH), T3 (Total and Free), T4 (Total and Free), prolactin, sex hormone binding globulin (SHBG), and insulin. Only clinically significant changes will be reported.
Measured: 2 weeks
Secondary outcomes (6)
Change in Frequency of Vasomotor Symptoms (Hot Flashes) From Baseline
Frequency is the number of vasomotor symptoms (hot flashes) recorded by the subject in the continuous diary.
Week 1
Measured: At Week 1 relative to Baseline
Change in Frequency Vasomotor Symptoms (Hot Flashes) From Baseline
Frequency is the number of vasomotor symptoms (hot flashes) recorded by the subject in the continuous diary.
Week 2
Measured: At Week 2 relative to Baseline
Change in Severity of Vasomotor Symptoms (Hot Flashes) From Baseline
Patients recorded in a continuous diary the number of individual hot flashes experienced and rated the severity of each on a scale of mild, moderate, or severe where mild is assigned a value of 1, moderate a value of 2, and severe a value of 3 during data analysis.
Daily severity was calculated as [(1 × number of mild hot flashes) + (2 × number of moderate hot flashes) + (3 × number of severe hot flashes)]/total number of hot flashes reported. The value at Week 1 was subtracted from the value at Baseline to yield the impact on severity score. A negative change indicates a reduction in severity.
Measured: At Week 1 relative to Baseline
Change in Severity of Vasomotor Symptoms (Hot Flashes) From Baseline
Patients recorded in a continuous diary the number of individual hot flashes experienced and rated the severity of each on a scale of mild, moderate, or severe where mild is assigned a value of 1, moderate a value of 2, and severe a value of 3 during data analysis.
Daily severity was calculated as [(1 × number of mild hot flashes) + (2 × number of moderate hot flashes) + (3 × number of severe hot flashes)]/total number of hot flashes reported. The value at Week 2 was subtracted from the value at Baseline to yield the impact on severity score. A negative change indicates a reduction.
Measured: At Week 2 relative to Baseline
Change in Hot Flash Severity Score Vasomotor Symptoms From Baseline
The hot flash severity score is a composite of the frequency and severity of hot flashes, and was calculated as follows: [number of mild hot flashes on Day Y x 1] + [number of moderate hot flashes on Day Y x 2] + [number of severe hot flashes on Day Y x 3].
The value at Week 1 was subtracted from the value at Baseline to yield the impact on the composite hot flash severity score. A negative change indicates a reduction.
Measured: At Week 1 relative to Baseline
Change in Hot Flash Severity Score of Vasomotor Symptoms From Baseline
The hot flash severity score is a composite of the frequency and severity of hot flashes, and was calculated as follows: [number of mild hot flashes on Day Y x 1] + [number of moderate hot flashes on Day Y x 2] + [number of severe hot flashes on Day Y x 3].
The value at Week 2 was subtracted from the value at Baseline to yield the impact on hot flash severity score. A negative change indicates a reduction in severity.
Measured: At Week 2 relative to Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start30 Mar 2022
- Primary completion4 Mar 2023
- Study completion4 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-menopausal Vasomotor SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acer Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Boston, MSN, APNP, Principal investigator, Spaulding Clinical Research LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325775
- Sponsor's protocol ID
- ACER-801-201
- Status last verified
- Jun 2024
- First submitted
- 27 Mar 2022
- Last updated
- 7 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of ACER-801 for Treatment of Moderate to Severe Vasomotor Symptoms (VMS) Associated With Menopause
- ClinicalTrials.gov ID
- NCT05325775
- Acronym / sponsor ID
- ACER-801-201
- Conditions
- Post-menopausal Vasomotor Symptoms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Acer Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 4 Mar 2023 (actual)
- Study completion
- 4 Mar 2023 (actual)
- First posted
- 13 Apr 2022 (actual)
- Results
- Posted 7 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| ACER-801 50 mg BID | Experimental | Drug: ACER-801 50 mg BIDACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily) |
| ACER-801 100 mg BID | Experimental | Drug: ACER-801 100 mg BIDACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily) |
| ACER-801 200 mg BID | Experimental | Drug: ACER-801 200 mg BIDACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (4 x Placebo of ACER-801 twice daily) |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Post-menopausal female subjects 40-65 years of age, inclusive.
- At baseline women:
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACER-801 50 mg BIDAlso: osanetant50 mg BID (twice daily) | Drug | ACER-801 50 mg BID |
| ACER-801 100 mg BIDAlso: osanetant100 mg BID (twice daily) | Drug | ACER-801 100 mg BID |
| ACER-801 200 mg BIDAlso: osanetant200 mg BID (twice daily) | Drug | ACER-801 200 mg BID |
| PlaceboAlso: Placebo of ACER-801Placebo | Drug | Placebo |
Primary outcome
Peak Plasma Concentration (Cmax) of ACER-801
Time frame: Day 1
maximum concentration of ACER-801 measured at Day 1 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Cmax (mean, SD) data are available due to abbreviated data analyses.
Peak Plasma Concentration (Cmax) of ACER-801
Time frame: Day 14
maximum concentration of ACER-801 measured at Day 14 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Cmax (mean, SD) data are available due to abbreviated data analyses.
Peak Plasma Concentration (Cmax) of ACER-801 Metabolite
Time frame: Day 1
peak concentration of ACER-801 metabolite measured at Day 1 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Cmax (mean, SD) data are available due to abbreviated data analyses.
Peak Plasma Concentration (Cmax) of ACER-801 Metabolite
Time frame: Day 14
peak concentration of ACER-801 metabolite measured at Day 14 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Cmax (mean, SD) data are available due to abbreviated data analyses.
Time to Reach Maximum Concentration (Tmax) of ACER-801
Time frame: Day 1
time to reach maximum concentration of ACER-801 measured at Day 1 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Tmax (mean, SD) data are available due to abbreviated data analyses.
Time to Reach Maximum Concentration (Tmax) of ACER-801
Time frame: Day 14
time to reach maximum concentration of ACER-801 at Day 14 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Tmax (mean, SD) data are available due to abbreviated data analyses.
Time to Reach Maximum Concentration (Tmax) of ACER-801 Metabolite
Time frame: Day 1
time to reach maximum concentration of ACER-801 metabolite at Day 1 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Tmax (mean, SD) data are available due to abbreviated data analyses.
Time to Reach Maximum Concentration (Tmax) of ACER-801 Metabolite
Time frame: Day 14
Time to reach maximum concentration of ACER-801 metabolite at Day 14 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Tmax (mean, SD) data are available due to abbreviated data analyses.
Area Under the Concentration Curve From Dosing to the Time of the Last Measured Concentration (AUClast) of ACER-801
Time frame: Day 1
Area under the concentration time curve (AUC) from the time of dosing (0 hour) to the time of the last quantifiable (positive) concentration (Tlast) of ACER-801, calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method) Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only AUClast (mean, SD) data are available due to abbreviated data analyses.
Area Under the Concentration Curve From Dosing to the Time of the Last Measured Concentration (AUClast) of ACER-801
Time frame: Day 14
Area under the concentration time curve (AUC) from the time of dosing (0 hour) to the time of the last quantifiable (positive) concentration (Tlast) of ACER-801, calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method) Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only AUClast (mean, SD) data are available due to abbreviated data analyses.
Area Under the Concentration Curve From Dosing to the Time of the Last Measured Concentration (AUClast) of ACER-801 Metabolite
Time frame: Day 1
Area under the concentration time curve (AUC) from the time of dosing (0 hour) to the time of the last quantifiable (positive) concentration (Tlast) of ACER-801 metabolite, calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method) Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only AUClast (mean, SD) data are available due to abbreviated data analyses.
Area Under the Concentration Curve From Dosing to the Time of the Last Measured Concentration (AUClast) of ACER-801 Metabolite
Time frame: Day 14
Area under the concentration time curve (AUC) from the time of dosing (0 hour) to the time of the last quantifiable (positive) concentration (Tlast) of ACER-801 metabolite, calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method) Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only AUClast (mean, SD) data are available due to abbreviated data analyses.
Half-life (T1/2) of ACER-801
Time frame: Day 1
Terminal elimination half-life of ACER-801
Half-life (T1/2) of ACER-801
Time frame: Day 14
Terminal elimination half-life of ACER-801
Half-life (T1/2) of ACER-801 Metabolite
Time frame: Day 1
Terminal elimination half-life of ACER-801 metabolite
Half-life (T1/2) of ACER-801 Metabolite
Time frame: Day 14
Terminal elimination half-life of ACER-801 metabolite
Number and Percentage of Adverse Events ≥ 5%
Time frame: 2 weeks
An Adverse Event (AE) is defined as any untoward medical occurrence associated with the use of the investigational product in humans, whether or not considered related to investigational product. An AE can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with any use of the investigational product, without any judgment about causality and irrespective of route of administration, formulation, or dose, including an overdose.
Number and Percentage of Serious Adverse Events (SAE)
Time frame: 2 weeks
An AE is considered "serious" if, in the view of either the investigator or Acer, it results in any of the following outcomes: Death, Is immediately life threatening; Requires in-patient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability or incapacity; Results in a congenital abnormality or birth defect; Is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
Number and Percentage of Subjects Who Discontinued From the Study
Time frame: Over 2 weeks
Discontinuation or withdrawal from the study.
Number of Patients With a Clinically Significant Change From Baseline in Abnormalities Detected During Physical Examination
Time frame: At Day 14 relative to Baseline
A physician or appropriately qualified delegate conducted a full physical examination at baseline and at Day 14. The investigator decides if findings are considered abnormal at baseline and at Day 14 and whether the change is clinically significant. Only clinically significant changes will be reported.
Accumulation Ratio for Cmax (ARcmax) of ACER-801
Time frame: Day 14
Cmax (maximum concentration) Accumulation Ratio calculated as Cmax,Day14/ Cmax,Day1 and AUCt,Day14/ AUCt,Day1, where the dosing interval t is 12h.
Accumulation Ratio for AUC (ARauc) of ACER-801
Time frame: Day 14
AUC (area under the curve) Accumulation Ratio calculated as Cmax,Day14/ Cmax,Day1 and AUCt,Day14/ AUCt,Day1, where the dosing interval t is 12h.
Accumulation Ratio for Cmax (ARcmax) of ACER-801 Metabolite
Time frame: Day 14
Cmax (maximum concentration) Accumulation Ratio calculated as Cmax,Day14/ Cmax,Day1 and AUCt,Day14/ AUCt,Day1, where the dosing interval t is 12h.
Accumulation Ratio for AUC (ARauc) of ACER-801 Metabolite
Time frame: Day 14
AUC (area under the curve) Accumulation Ratio calculated as Cmax,Day14/ Cmax,Day1 and AUCt,Day14/ AUCt,Day1, where the dosing interval t is 12h.
Metabolite: Parent Ratio of AUC (MRauc)
Time frame: Day 1
MR = Metabolite:Parent Ratio calculated as Cm,day14/ Cp,day1 and AUCt,m,day14/ AUCt,p,day1, where m and p are the metabolite and parent drug, respectively, and t is the dosing interval (12 h). AUC = area under the curve
Metabolite: Parent Ratio of AUC (MRauc)
Time frame: Day 14
AUC (area under the curve) MR = Metabolite:Parent Ratio calculated as Cm,day14/ Cp,day1 and AUCt,m,day14/ AUCt,p,day1, where m and p are the metabolite and parent drug, respectively, and t is the dosing interval (12 h).
Metabolite:Parent Ratio of Cmax (MRcmax)
Time frame: Day 1
MR = Metabolite:Parent Ratio calculated as Cm,day14/ Cp,day1 and AUCt,m,day14/ AUCt,p,day1, where m and p are the metabolite and parent drug, respectively, and t is the dosing interval (12 h). ACER-801 (parent); Cmax (maximum concentration)
Metabolite:Parent Ratio of Cmax (MRcmax)
Time frame: Day 14
MR = Metabolite:Parent Ratio calculated as Cm,day14/ Cp,day1 and AUCt,m,day14/ AUCt,p,day1, where m and p are the metabolite and parent drug, respectively, and t is the dosing interval (12 h). ACER-801 (parent); Cmax (maximum concentration)
Area Under the Concentration Curve From t0 to Infinite Time (AUCinf) of ACER-801
Time frame: Day 1
AUC from the time of dosing (0 hour) extrapolated to infinity, calculated as AUClast + Clast/λz, where Clast was the last quantifiable concentration, and λz was the terminal elimination rate constant Reliability of AUCinf values was contingent upon AUCext and λz Profiles with AUCext ≤20% and a λz which met reporting criteria were considered reliable and AUCinf was reported. For profiles that did not meet these criteria, AUCinf and any parameter requiring AUCinf for computation were not reported.
Area Under the Concentration Curve From t0 to Infinite Time (AUCinf) of ACER-801
Time frame: Day 14
AUC from the time of dosing (0 hour) extrapolated to infinity, calculated as AUClast + Clast/λz, where Clast was the last quantifiable concentration, and λz was the terminal elimination rate constant Reliability of AUCinf values was contingent upon AUCext and λz Profiles with AUCext ≤20% and a λz which met reporting criteria were considered reliable and AUCinf was reported. For profiles that did not meet these criteria, AUCinf and any parameter requiring AUCinf for computation were not reported.
Area Under the Concentration Curve From t0 to Infinite Time (AUCinf) of ACER-801 Metabolite
Time frame: Day 1
AUC from the time of dosing (0 hour) extrapolated to infinity, calculated as AUClast + Clast/λz, where Clast was the last quantifiable concentration, and λz was the terminal elimination rate constant Reliability of AUCinf values was contingent upon AUCext and λz Profiles with AUCext ≤20% and a λz which met reporting criteria were considered reliable and AUCinf was reported. For profiles that did not meet these criteria, AUCinf and any parameter requiring AUCinf for computation were not reported.
Area Under the Concentration Curve From t0 to Infinite Time (AUCinf) of ACER-801 Metabolite
Time frame: Day 14
AUC from the time of dosing (0 hour) extrapolated to infinity, calculated as AUClast + Clast/λz, where Clast was the last quantifiable concentration, and λz was the terminal elimination rate constant Reliability of AUCinf values was contingent upon AUCext and λz Profiles with AUCext ≤20% and a λz which met reporting criteria were considered reliable and AUCinf was reported. For profiles that did not meet these criteria, AUCinf and any parameter requiring AUCinf for computation were not reported.
Number of Subjects With a Clinically Significant Change From Baseline for Clinical Laboratory Evaluations: HEMATOLOGY
Time frame: Over 2 weeks
Blood samples will be measured for hemoglobin, hematocrit, white blood count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), platelet count, red blood cell count (including mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration). Only clinically significant changes will be reported.
Number of Subjects With a Clinically Significant Change From Baseline for Clinical Laboratory Evaluations: SERUM CHEMISTRY
Time frame: 2 weeks
Blood samples will be measured for albumin, alkaline phosphatase, total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen, calcium, carbon dioxide, chloride, potassium, sodium, total cholesterol, creatinine, gamma glutamyl transferase, glucose, lactate dehydrogenase, phosphorus, total protein, uric acid. Only clinically significant changes will be reported.
Number of Subjects With a Clinically Significant Change From Baseline for Clinical Laboratory Evaluations: COAGULATION
Time frame: 2 weeks
Blood samples will be measured for prothrombin time, partial thromboplastin time, international normalized ratio. Only clinically significant changes will be reported.
Number of Subjects With a Clinically Significant Change From Baseline for Clinical Laboratory Evaluations: URINALYSIS
Time frame: 2 weeks
Urine samples will be measured for pH, specific gravity, protein, glucose, ketones, bilirubin. Only clinically significant changes will be reported.
Number of Subjects With a Clinically Significant Change From Baseline for Clinical Laboratory Evaluations: BONE DENSITY MARKERS
Time frame: 2 weeks
Blood samples not available/collected for testing. Blood samples will be measured for Bone Specific Alkaline Phosphatase (BSAP), osteocalcin, amino terminal propeptide of type 1 collagen (P1NP) and Collagen Type- C-Telopeptide (CTX). Only clinically significant changes will be reported.
Number of Subjects With a Clinically Significant Change From Baseline for Clinical Laboratory Evaluations: HORMONES
Time frame: 2 weeks
Blood samples not available/collected for testing. Blood samples will be measured for catecholamines, vasopressin, gonadotropins, estradiol, testosterone, follicle stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), cortisol, thyroid-stimulating hormone (TSH), T3 (Total and Free), T4 (Total and Free), prolactin, sex hormone binding globulin (SHBG), and insulin. Only clinically significant changes will be reported.
6 secondary outcomes
Change in Frequency of Vasomotor Symptoms (Hot Flashes) From Baseline
Time frame: At Week 1 relative to Baseline
Change in Frequency Vasomotor Symptoms (Hot Flashes) From Baseline
Time frame: At Week 2 relative to Baseline
Change in Severity of Vasomotor Symptoms (Hot Flashes) From Baseline
Time frame: At Week 1 relative to Baseline
Change in Severity of Vasomotor Symptoms (Hot Flashes) From Baseline
Time frame: At Week 2 relative to Baseline
Change in Hot Flash Severity Score Vasomotor Symptoms From Baseline
Time frame: At Week 1 relative to Baseline
Change in Hot Flash Severity Score of Vasomotor Symptoms From Baseline
Time frame: At Week 2 relative to Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Post-menopausal Vasomotor Symptoms
Not yet recruiting
Exercise Training Intensity and Nitrate Supplementation in Post-Menopausal Females on Hormone Therapy
Postmenopausal Female Patients, Vasomotor Symptoms
RecruitingPhase 4
The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity
Obesity, Menopause Hot Flashes
Recruiting
Randomized Evaluation of Natural Extract for Menopausal Wellness (RENEW)
Menopause, Hot Flashes
Recruiting
Haelan 951 for Menopause Symptoms in Peri- and Postmenopausal Women
Menopause, Menopause Hot Flashes
Recruiting
JDS-HF3.0 Supplementation on Menopause Related Quality of Life Outcomes in Postmenopausal Women
Joint Discomfort, Joint Pain, Stiffness, Function
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Boston, MSN, APNP principal investigator
Spaulding Clinical Research LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ACER-801 50 mg BID, ACER-801 100 mg BID and ACER-801 200 mg BID in people with Post-menopausal Vasomotor Symptoms, run by Acer Therapeutics Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) of ACER-801 (time frame: Day 1). The study lists 38 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.