Name: SKY-0515 in Huntington's disease: Special populations
Published: 2026-09-16T18:00:43-04:00

Product information and disease description Product description Product information

Special populations

4 evidence topics · 3 sources

Age range studied

Study	Quoted criterion
Part C, participants with HD	“Males and females, aged between 25 and 70 years.”

“Healthy male or female, aged between 18 and 70 years, inclusive at screening.” (opens the source at this quote in a new tab)

“You must be 25 years or older.” (opens the source at this quote in a new tab)

Renal and hepatic impairment: phase 1 exclusion criteria

“Laboratory results at screening that indicate inadequate renal function (estimated creatinine clearance of lesser than 30 mL/min calculated by the Cockcroft and Gault formula).” (opens the source at this quote in a new tab)
“Liver function test results elevated more than 1.5-fold above the ULN for GGT, ALP, AST or ALT.” (opens the source at this quote in a new tab)

Pregnancy, lactation, and contraception: phase 2/3 criteria

“Women who can have children must have a negative pregnancy test before starting and use two types of birth control during the study and for 30 days after the last dose of the study drug.” (opens the source at this quote in a new tab)
“Men must agree to use birth control during the study and for 90 days after the last dose.” (opens the source at this quote in a new tab)
“You are pregnant, breastfeeding, or planning to become pregnant during the study.” (opens the source at this quote in a new tab)

Psychiatric history: phase 2/3 exclusion

“You have a history of suicidal thoughts, severe depression, or have attempted suicide in the past year.” (opens the source at this quote in a new tab)

Pediatric and juvenile-onset HD, pharmacokinetics in renal or hepatic impairment

No evidence found.