Title
Phase 1 Safety Study of ALK-001 in Healthy Volunteers
A Phase 1, Open Label, Repeat Dose Study to Investigate the Safety and Pharmacokinetics of 4-week Daily Dosing of ALK-001 in Healthy Volunteers
Phase
Phase 1Lead Sponsor
Alkeus Pharmaceuticals, Inc.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Stargardt Disease Age-related Macular Degeneration Other Retinal DystrophiesIntervention/Treatment
alk-001 ...Study Participants
40This protocol is a phase 1 clinical study to assess the safety and pharmacokinetics of ALK-001 in healthy volunteers. Please contact trials@alkeus.com for any questions.
Daily, oral administration of ALK-001 capsules.
Main Inclusion Criteria Adult between 21 and 70 years old (inclusive) Healthy subject, as judged by investigator Subject is able and willing to comply with study requirements (study medication compliance, schedule of follow-up visits) Subject has provided informed consent to participate If female, subject uses a medically accepted birth control method and agrees to use such a method for entire clinical trial period Main Exclusion Criteria: Subject has taken disallowed items during the past 30 days Female with a positive urine pregnancy test at screening Lactating woman Subject has participated in any clinical study involving an investigational drug, biologic or device, during the past 30 days History or current evidence of gastrointestinal malabsorption Subject has any other medical condition, which in the opinion of the investigator, is likely to prevent compliance with protocol and/or interfere with successful collection of study Subject has, in the opinion of investigator, clinically significant laboratory result(s), positive drug or alcohol screening, or ECG, which makes subject unsuitable for participation.