Safety and Tolerability Study of Lu AF35700 After Repeated Dosing in Patients With Schizophrenia
- Registration Number
- NCT02202226
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
The purpose of this study is to evaluate the tolerability and safety of Lu AF35700 after repeated oral dosing to patients with schizophrenia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
Inclusion Criteria
- Men or women between 18 and 60 years (extremes included)
- BMI of ≤38
- Primary diagnosis of schizophrenia according to DSM-IV-TR™ (codes 295.10, 295.20, 295.30, 295.90)
- Clinical Global Impression - Severity of Illness (CGI-S) score ≤4 (moderately ill) at screening and baseline
- PANSS total score ≤80
- Score ≤4 (moderate) on the following PANSS items at screening and safety baseline: P7 (hostility), G8 (uncooperativeness)
- Willing to be hospitalised for 4 to 5 weeks after the Safety Baseline Visit
Exclusion Criteria
- The patient experienced an acute exacerbation requiring hospitalization within the last 6 months
- The patient experienced an acute exacerbation requiring change in antipsychotic medication (with reference to drug or dose) within the last 4 weeks
- The patient has a diagnosis or history of substance dependence (except nicotine) or substance abuse according to DSM-IV-TR® criteria ≤3 months prior to screening
- The patient smokes >20 cigarettes per day
Other protocol-defined inclusion and exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Matching placebo Placebo Oral solution Lu AF35700 oral solution (1 mg/mL) Lu AF35700 Planned daily doses range from 5 mg/day to 30 mg/day for 3 weeks. Weekly doses up to 75 mg/week for 3 weeks.
- Primary Outcome Measures
Name Time Method Change from baseline in AIMS, BARS and SAS Total score Baseline to day 21 Abnormal movement rating scale
Columbia Suicide Severity Rating Scale (C-SSRS) Sceening to day 78 (up to 8 weeks after last dose) Absolute values and change from baseline in safety variables (Adverse events, clinical safety laboratory tets, vital signs, weight, and ECG) Screening to day 78 (up to 8 weeks after last dose)
- Secondary Outcome Measures
Name Time Method Day 21 area under the Lu AF35700 and Lu AF36152 plasma concentration-time curve from 0-24 hours post dose (AUC0-tau) in a daily dosing regime Day 21 in the dosing period Maximum observed concentration (Cmax) of Lu AF35700 and Lu AF36152 Day 1 and 21 in the dosing period Half-lives (t½) of Lu AF35700 and Lu AF36152 Day 1 and 21 in the dosing period Day 14-21 area under the Lu AF35700 and LuAF36152 plasma-concentration-time curve from 0-168 hours post-dose (AUCtau) in a weekly dosing regimen Day 14-21 in the dosing period
Related Research Topics
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Trial Locations
- Locations (1)
PAREXEL Phase I Unit
🇺🇸Glendale, California, United States
PAREXEL Phase I Unit🇺🇸Glendale, California, United States