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Woodland Research Northwest
Schizophrenia QTc Case Study
A Phase 1 Study to Evaluate the Effect of Multiple Doses Of XXXX on QTc Interval in Subjects with Schizophrenia
Site Achievements:
- Top Enroller
- Randomized 35% ofstudy
- 27% Screen Fail Rate
- 97% CompletionRate
100
Study subjects
4.5 Months
Enrollment period
29
Vitals per subject
“The entire team at Woodland Research Northwest have been a pleasure to work with. The attention to detail in this complex clinical trial was critical to its successful execution. The identification of proper patients and the number randomized significantly contributed to meeting our study timelines. The site’s overall performance provided us with a high level of confidence and we would not hesitate to work with them in the future.” - Clinical Trial Manager
Phase: 1
Indication: Schizophrenia (Stable)
Individuals enrolled: Stable schizophrenics between 18 and 60 years ofage which 30% are female
Study Duration: Approximately 10 weeks including 43 days for Screening,17 days inpatient, and up to 15 days for safety follow-up
Enrollment period: 4.5 months
# of Study Subjects: 100
Method of Administration: Oral
Objectives
Primary
To evaluate the effects of multiple therapeutic and supra therapeutic oral doses of XXXX on the heart rate corrected QT (QTc) interval
Secondary
- To evaluate the effect of XXXX on otherelectrocardiogram (ECG) parameters; RR, PR, and
- QRS interval, and T-Wave morphology
- To demonstrate sensitivity of the study to detect asmall QT effect using moxifloxacin as a positive control.
- To evaluate the safety and tolerability of XXXX
- To evaluate the PK/PD relationship between effectof XXXX on ECG and plasma concentrations of XXXX,XXXX, and its metabolites, XXXX and XXXX
ECGs – 36 per subject – 18 triplicate, 18 single
Lab Assessments – PK draws – 49 per subject
Vitals -29 per subject
Holter – 24-hour continuous ECG data recordings collected at baseline (Day -1) and on Days 1,4,8,13 and 14for central read. Replicate 12-lead ECGs be extracted from continuous recording at 10 timepoints from pre-dose through 24 hours post dose on each day totaling 140 per subject
