A study to evaluate the effect of the time interval between spinal tap procedure on the chemistry measurements in blood and in the fluid surrounding the brain and spinal cord in healthy participants
- Conditions
- Not ApplicableHealthy Volunteers
- Registration Number
- ISRCTN13868766
- Lead Sponsor
- Genentech
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 40
1. Participants must have a total body weight between 45 and 120 kilograms (kg), inclusive
2. Good health, demonstrated by no clinically significant findings from medical history, physical examination, laboratory tests, and vital signs
3. Agreement not to have any additional blood draws or CSF sampling for the duration of the study
4. No contraindication to lumbar dural puncture, including coagulopathy, concomitant anticoagulation, thrombocytopenia, prior lumbar spinal surgery, abnormal brain imaging, or other factor that precludes safe LP in the opinion of the investigator
1. Treatment with any vaccine within 14 days prior to Day 1 or vaccination scheduled to occur during the study
2. Poor peripheral venous access
3. History of seizures, with the exception of childhood febrile seizures
4. History of prior traumatic brain injury graded as moderate or severe
5. Abnormal brain imaging findings that preclude safe LP
6. History of schizophrenia, schizoaffective disorder, or bipolar disorder
7. History of malignancy
8. Positivity for tuberculosis (TB) during screening or within 3 months prior to screening
9. Positive human immunodeficiency virus (HIV) test at screening
10. Positive hepatitis B surface antigen (HBsAg) test at screening
11. Positive hepatitis C virus (HCV) antibody test at screening
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Validity, stability, and variability of CSF analyte values across different inter-LP interval durations measured using the relative and absolute inter-LP differences for CSF analyte values in each cohort using CSF fluid collected during LP on Days 1, 4, 8, 15, and 29
- Secondary Outcome Measures
Name Time Method 1. Number of participants with adverse events (AEs), and severity of AEs measured according to Division of AIDS (DAIDS) toxicity scale from screening (Day -28) up to follow-up (Up to Day 30) <br>2. Stability and variability of plasma and serum analyte values across different inter-LP interval durations measured using the relative and absolute inter-LP differences for plasma or serum analyte values in each cohort using blood samples collected during LP on Days 1, 4, 8, 15 and 29<br>