Can patients have a “drug holiday” or can dosing be inturrupted during either of the dosing periods?
If a subject experiences an AE which the investigator believes is treatment related and which the subject finds intolerable, a break in dosing of up to 1 week is permitted. If on reintroduction of the IMP, the AE recurs and remains intolerable the IMP will then be withdrawn altogether. A break in dosing will not result in extension of the overall dosing period.
A subject may only have one drug holiday for a given AE but the protocol does not prohibit a second drug holiday for a different event. In the unlikely event that a second drug holiday is being considered, please contact the medical monitor to discuss first.