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SKY-0515

Huntington's disease

Last updated
211 sources

Product information and disease descriptionProduct descriptionProduct informationPharmacology

Pharmacokinetics

4 evidence topics · 4 sources

Healthy volunteers: systemic exposure

“The Safety Review Committee has determined that SKY-0515 has been generally well tolerated at all tested doses with a dose proportional increase in systemic exposure” (opens the source at this quote in a new tab)

Participants with HD: dose proportionality and steady state

“The pharmacokinetic properties of SKY-0515 in patients demonstrated a linear and dose proportional PK profile reaching steady state in 5-7 days, and favorable brain penetrance.” (opens the source at this quote in a new tab)

“SKY-0515 shows an approximate 3-fold increase in exposure between 3 mg and 9 mg doses and reaches a plateau by day 8, showing stable concentration at all subsequent time points.” (opens the source at this quote in a new tab)

Participants with HD: CSF penetration
DoseKp,uu
3 mg (N = 10)“0.84”
9 mg (N = 7)“0.73”
Elimination after discontinuation

“In HD patients, SKY-0515 reaches stable levels in about a week and is eliminated in ~1 week after discontinuing drug (data not shown).” (opens the source at this quote in a new tab)

Terminal half-life, food effect results, metabolism, and renal excretion

No evidence found.