Embed Notice

Day 017 of the Multiple Sclerosis Study
(Compound Day 14) Thursday on 2024-09-19
Groningen, Netherlands (GMT+1)

• BP = blood pressure
• HR = heart rate
• SB = (study bound) meal controlled for the study

06:00 Telemetry (Connect)
06:30 Intravenous catheter (Check)
07:30 Wellbeing (Pre dose)
07:40 Urine clinical chemistry (Not sooner)
07:40 Body weight
07:40 Physician task

• Neurological examination
• Brief Psychiatric Rating Scale
• C-SSRS

07:50 Telemetry Start
08:00 Telemetry (Start subject lay down [312h])
08:10 Telemetry (Make ECG print [3x])
08:15 Telemetry (Stop subject lay down [312h])
08:15 Vital signs (BP, HR)
08:20 Blood sampling

• PK: Sample 35
• PL PD 2-AG: Sample 112
• SR PD 2-AG: Sample 318
• Clinical chemistry

08:20 Transfer bloodtubes
08:30 Cogstate (Neurocognitive Test Battery)
09:00 Urine collection

• Urinate into tollet
• Start container 7

09:10 SB Breakfast (Start)
9:40 Dose (RO7268489 or placebo)
9:40 Dose check

09:40 Water fast (Start)
09:45 Blood sampling (PK: Sample 36)
09:45 Transfer bloodtubes
09:50 Telemetry (Start subject lay down [312.5h])
10:00 Telemetry (Make ECG print [3x])
10:05 Telemetry - Stop subject lay down [312.5h])
10:05 Vital signs (BP, HR)
10:10 Blood sampling

• PK: Sample 37-'SR PD 2-AG: Sample 319

10:10 Transfer bloodtubes
10:20 Telemetry (Start subject lay down [313h])
10:30 Telemetry (Make ECG print [3x])
10:35 Telemetry (Stop subject lay down [313h])
10:35 Vital signs (BP, HR)
10:40 Blood sampling (PK: Sample 38)
10:40 Transfer bloodtubes
11:10 Blood sampling (PK: Sample 39)
11:10 Transfer bloodtubes
11:20 Telemetry (Start subject lay down [314h])
11:30 Telemetry (Make ECG print [3x])
11:35 Telemetry (Stop subject lay down [314h])
11:35 Vital signs
11:40 Blood sampling

• PK: Sample 40
• PL PD 2-AG: Sample 113
• SR PD 2-AG: Sample 320

11:40 Transfer bloodtubes
11:40 Water fast (Stop)
12:20 Telemetry (Start subject lay down [315h])
12:30 Telemetry (Make ECG print [3x measurement])
12:35 Telemetry (Stop subject lay down [315h])
12:35 Vital signs (BP, HR)
12:40 Blood sampling (PK: Sample 41)
12:40 Transfer bloodtubes
12:40 Cogstate (Neurocognitive Test Battery)
13:20 Telemetry (Start subject lay down [316h])
13:30 Telemetry (Make ECG print [3x measurement])
13:35 Telemetry (Stop subject lay down [316h])
13:35 Vital signs (BP, HR)
13:40 Blood sampling

• PK: Sample 42
• PL PD 2-AG: Sample 114
• SR PD 2-AG: Sample 321

13:40 Transfer bloodtubes
13:40 SB Lunch (Check post dose restrictions)
15:00 Intravenous catheter (Check)
15:20 Telemetry (Start subject lay down [318h])
15:30 Telemetry (Make ECG print [3x measurement])
15:35 Telemetry (Stop subject lay down [318h])
15:35 Vital signs (BP, HR)
15:40 Blood sampling (PK: Sample 43)
15:40 Transfer bloodtubes
15:40 Urine collection

• Stop container 7
• Start container 8

15:40 Transfer Urine containers
16:15 Telemetry (Continue)
16:15 Urine collection (Continue)
17:40 Blood sampling (PK: Sample 44)
17:40 Transfer bloodtubes
19:00 Wellbeing
19:20 Telemetry (Start subject lay down [322h])
19:30 Telemetry (Make ECG print [3x])
19:35 Telemetry Stop subject lay down [322h])
19:35 Vital signs (BP, HR)
19:40 Blood sampling

• PK: Sample 45
• SR PD 2-AG: Sample 322

19:40 Transfer bloodtubes
19:40 SB Dinner
21:20 Telemetry (Start subject lay down [324h])
21:30 Telemetry (Make ECG print [3x measurement])
21:35 Telemetry (Stop subject lay down [324h])
21:35 Vital signs (BP, HR)
21:40 Blood sampling (PK: Sample 46)
21:40 Transfer bloodtubes
21:40 Urine collection

• Stop container 8
• Start container 9

21:40 Transfer Urine containers
22:00 Intravenous catheter (Check)
23:15 Telemetry (Continue)
23:15 Urine collection (Continue)

To be continued...