Table 2. Treatments administered to subjects in the ex vivo and IBSM studies.
| Subject | Griseofulvin dose (mg) (number doses)a | Griseofulvin treatment duration (study day) | Commencement of artemether-lumefantrine treatment (study day) |
|---|---|---|---|
| Ex vivo study | |||
| E1-E3 | 500 (BD, 8) | Day 1 AM – Day 4 PM | NA |
| E4 | 2,000 (single dose) | Day 1 | NA |
| IBSM challenge study | |||
| I1 | 500 (BD, 7) | Day 6 AM – Day 9 AM | Day 9 PM |
| I2 | 500 (BD, 4) | Day 6 AM – Day 7 PM | Day 8 AM |
| I3b | 500 (BD, 7) | Day 6 AM – Day 9 AM | Day 9 PM (IV artesunate) |
| I4c | Mefloquine (687 mg, single dose) | Day 8 AM | Day 12 PM |
| I5 | 500 (BD, 8) | Day 6 AM – Day 9 PM | Day 10 AM |
| I6 and I7 | 500 (BD, 22) | Day -4 AM – Day 6 PM | Day 7 AM |
aBD: bi-daily dosage (AM and PM).
bSubject I3 was treated with IV artesunate (180 mg) on Day 9 PM at the hospital where he was admitted to treat a serious adverse event unrelated to the study (renal colic).
cSubject I4 was the control subject of IBSM Cohort 1 and was treated with mefloquine instead of griseofulvin. This subject also received treatment with artemether-lumefantrine.