Psychiatric Disorders MedDRA version: 20.0 Level: SOC Classification code 10037175 Term: Psychiatric disorders System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0 Level: HLT Classification code 10037177 Term: Infancy, childhood and adolescence psychiatric disorders NEC System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Pimavanserin 10 mg
Product Code: ACP-103
Pharmaceutical Form: Tablet
INN or Proposed INN: PIMAVANSERIN
CAS Number: 706782-28-7
Current Sponsor code: ACP-103
Other descriptive name: PIMAV
Sponsors
ACADIA Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study Population 1. Male or female subjects between the ages of =13 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Requires treatment with a medication prohibited by the protocol 2. Is taking more than 2 psychotropic medications at Screening 3. Has a history of mental retardation or persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure or drug induced seizure is not exclusionary. 4. Is at a significant risk of suicide, or is a danger to self or others, in the opinion of the Investigator based upon all available sources of information including C-SSRS at Screening or Baseline and including more than one life-threatening suicide attempt 5. Has a significant risk of violent behavior 6. Has a positive urine drug or alcohol test at Screening or positive urine drug dipstick or breathalyzer alcohol test result at Baseline 7. Has met DSM-5 criteria for substance use disorders within the last 6 months prior to Baseline 8. Consumes either more than 21 units of alcohol per week or 4 units of alcohol per day; 1 unit of alcohol is equivalent to 236 mL of beer, 118 mL of wine, or 130 mL of spirits 9. Excessive use of nicotine-containing products within 30 days before study drug administration or is using or has used topical or oral nicotine preparations for smoking cessation within the past 30 days before study drug administration 10. Consumes greater than 500 mg of caffeine or xanthine-containing products per day 11. Refuses to limit caffeine or xanthine-containing products to no more than 100 mg per day during the study 12. Refuses to abstain from alcohol, grapefruit foods or beverages, or Seville-orange containing foods or beverages, from 48 hours prior to check-in on Day -1 through the end of the study 13. Has any condition that would interfere with the ability to comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk 14. Has current evidence, or history within the previous 12 weeks prior to Screening, of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that, in the judgment of the Investigator, would jeopardize the safe participation of the subject in the study 15. Resting position systolic blood pressure (BP) >149 mmHg or 90 mmHg or 100 bpm at Screening (central vendor over-read ECGs) or at Baseline 17. Has a positive hepatitis B surface antigen or hepatitis C antibody test result at Screening 18. At Screening has a known history of a positive Human Immunodeficiency Virus (HIV) test result 19. Female subjects of childbearing potential who have a history of taking hormonal contraceptives within 30 days prior to Baseline (Day -1) 20. Has donated >500 mL of blood within 60 days prior to start of Screening 21. Has donated any plasma within 7 days prior to Baseline (Day -1) 22. Has 1 or more clinical laboratory test value(s) outside the range specified in the protocol, or any other clinically significant laboratory abnormality as determined by the Investigator or Medical Monitor at Screening 23. Has a history or presence in on at least one ECG at Screening (central vendor over-read ECGs) or at Baseline (tracings collected on the study-provided ECG device during the visit), of any of the cardiac conduction abnormalities set for
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the pharmacokinetics (PK) following multiple doses of pimavanserin (10, 20, or 34 mg) in adolescents with psychiatric disorders;Secondary Objective: To assess the safety and tolerability following multiple doses of pimavanserin (10, 20, or 34 mg) in adolescents with psychiatric disorders;Primary end point(s): Single dose (Day 1) PK endpoints are as follows: • AUC(0-24) (area under the plasma concentration-time curve from 0 to 24 hours) • AUC(0-24)normalized (AUC0-24 normalized to dose and body weight) • AUC0-t (area under the plasma concentration-time curve from time 0 to time of the last detectable concentration at time T) • AUC(0-t)normalized (AUC0-t normalized to dose and body weight) • Cmax (maximum observed plasma concentration) • Cmax,normalized (Cmax normalized to dose and body weight) • Tmax (time to maximum plasma concentration) Multiple dose (Day 20) PK endpoints are as follows: • AUCt (area under the plasma concentration-time curve during one dosing interval at steady state) • AUCt,normalized (AUCt normalized to dose and body weight) • Cmax-ss (Cmax at steady state) • Cmax-ss,normalized (Cmax-ss normalized to dose and body weight) • Rac(AUC) (accumulation ratio based on AUC) • Rac(Cmax) (accumulation ratio based on Cmax) • Tmax-ss (Tmax at steady state) • CL/F (apparent systemic clearance of pimavanserin) • Vss/F (apparent volume of distribution of pimavanserin at steady state) Trough level collected on Days 17 through 20 will be used to assess pimavanserin steady state as appropriate. When possible all noted PK parameters will also be calculated as appropriate for the pimavanserin metabolite (AC-279). ;Timepoint(s) of evaluation of this end point: Day 1-2: PK blood samples for pimavanserin and its primary metabolite, AC 279, will be collected predose and 1, 2, 4, 6, 9, 12, 16, 24 hours after pimavanserin administration. Day 17-19: PK blood samples for pimavanserin and its primary metabolite, AC 279, will be collected predos | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The safety assessments will include: • Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and withdrawals due to AEs • Frequency of potentially clinically significant findings on: o Physical examination findings o Clinical laboratory test results (to include hematology, serum chemistry, and urinalysis) o Vital sign measurements o 12-lead electrocardiograms (ECG) parameters • Change from Baseline on Udvalg for Kliniske Undersøgelser - side effect rating scale (UKU-SERS) scores • The incidence of subjects with suicidal ideation or suicidal behavior during the study as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) ;Timepoint(s) of evaluation of this end point: Within the whole duration of the study - a screening period lasting 1-28 days (1-4 weeks), a treatment period lasting 21 days (3 weeks), and a follow-up period lasting 28 days (approximately 4 weeks). | — |
Countries
Bulgaria, Russian Federation, United States
Contacts
Public ContactJim Harlick
ACADIA Pharmaceuticals Inc.
Outcome results
None listed