Phase 1 Safety Study of ALK-001 in Healthy Volunteers

NCT ID: NCT02230228

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-02-28

Brief Summary

This 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.

Conditions

Stargardt Disease; Age-related Macular Degeneration; Other Retinal Dystrophies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

ALK-001 capsules

Group Type: EXPERIMENTAL

ALK-001 (No generic name)

Intervention Type: DRUG

Daily, oral administration of ALK-001 capsules.

Interventions

ALK-001 (No generic name)

Daily, oral administration of ALK-001 capsules.

Intervention Type: DRUG

Other Intervention Names

C20-D3-Retinyl Acetate; C20 Deuterated vitamin A

Eligibility Criteria

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

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alkeus Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ALK001-P1001

Identifier Type: -

Identifier Source: org_study_id