Embed Notice

Day 004 of the Multiple Sklerosis Study
(Compound Day 1) Friday on 2024-09-06
Groningen, Netherlands (GMT+1)

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

06:30 Intravenous catheter (Check)
07:15 Telemetry (Continue)
07:30 Wellbeing (Pre dose)
08:10 Telemetry (Start subject lay down [0h])
08:20 Telemetry (Make ECG print [3x])
08:25 Telemetry (Stop subject lay down [0h])
08:25 Vital signs (BP, HR)
08:30 Blood sampling

• PK: Sample 1
• PL PD 2-AG: Sample 102
• SR PD 2-AG: Sample 302
• Genotyping: Sample 401

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

• Urinate into toilet
• Start container 1

09:10 SB Breakfast (Start)
09:40 Dose (RO7268489 or placebo)
09:40 Dose (check)
09:40 Water fast (Start)
09:50 Telemetry (Start subject lay down [0.50h])
10:00 Telemetry (Make ECG print [3x measurement])
10:05 Telemetry (Stop subject lay down [0.50h])
10:05 Vital signs (BP, HR)
10:10 Blood sampling

• PK: Sample 2
• SR PD 2-AG SR: Sample 303

10:10 Transfer bloodtubes
10:20 Telemetry (Start subject lay down [1h])
10:30 Telemetry (Make ECG print [3x])
10:35 Telemetry (Stop subject lay down [1h])
10:35 Vital signs (BP, HR)
10:40 Blood sampling (PK: Sample 3)
10:40 Transfer bloodtubes
11:10 Blood sampling (PK: Sample 4)
11:10 Transfer bloodtubes
11:20 Telemetry (Start subject lay down [2h])
11:30 Telemetry (Make ECG print [3x])
11:35 Telemetry (Stop subject lay down [2h])
11:35 Vital signs (BP, HR)
11:40 Blood sampling

• PK: Sample 5
• PL PD 2-AG: Sample 103
• SR PD 2-AG: Sample 304

11:40 Transfer bloodtubes
11:40 Water fast (Stop)
12:20 Telemetry (Start subject lay down [3h])
12:30 Telemetry (Make ECG print [3x])
12:35 Telemetry (Stop subject lay down [3h])
12:35 Vital signs (BP, HR)
12:40 Blood sampling (PK: Sample 6)
12:40 Transfer bloodtubes
12:40 Cogstate (Neurocognitive Test Battery)
13:20 Telemetry (Start subject lay down [4h])
13:30 Telemetry (Make ECG print [3x])
13:35 Telemetry (Stop subject lay down [4h])
13:35 Vital signs (BP, HR)
13:40 Blood sampling

• PK: Sample 7
• PL PD 2-AG: Sample 104
• SR. PD 2-AG: Sample 305

13:40 Transfer bloodtubes
13:40 SB Lunch (Check post dose restrictions)
15:00 Intravenous catheter (Check)
15:20 Telemetry (Start subject lay down [6h])
15:30 Telemetry (Make ECG print [3x])
15:35 Telemetry (Stop subject lay down [6h])
15:35 Vital signs (BP, HR)
15:40 Blood sampling (PK: Sample 8)
15:40 Transfer bloodtubes
15:40 Urine collection

• Stop container 1
• Start container 2

15:40 Transfer Urine containers
16:15 Telemetry (Continue)
16:15 Urine collection (Continue)
17:40 Blood sampling (PK: Sample 9)
17:40 Transfer bloodtubes
17:40 Telemetry

• Stop and disconnect
• Subject can take a shower

18:10 Telemetry (Connect and start)
19:00 Wellbeing
19:20 Telemetry (Start subject lay down [10h])
19:30 Telemetry (Make ECG print [3x])
19:35 Telemetry (Stop subject lay down [10h])
19:35 Vital signs (BP, HR)
19:40 Blood sampling

• PK: Sample 10
• SR PD 2-AG: Sample 306

19:40 Transfer bloodtubes
19:40 SB Dinner
21:20 Telemetry (Start subject lay down [12h])
21:30 Telemetry (Make ECG print [3x])
21:35 Telemetry (Stop subject lay down [12h])
21:35 Vital signs (BP, HR)
21:40 Blood sampling (PK: Sample 11)
21:40 Transfer bloodtubes
21:40 Urine collection

• Stop container 2
• Start container 3

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

85 appointments in total
21 blood samples being drawn
9 times are vital signs recorded

To be continued...