Phase 1 Safety Study of ALK-001 in Healthy Volunteers

This protocol is a phase 1 clinical study to assess the safety and pharmacokinetics of ALK-001 in healthy volunteers. Please contact [email protected] for any questions.

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Key information

Conditions

Stargardt Disease Age-Related Macular Degeneration Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Macular Degeneration Other Retinal Dystrophies Retinal Degeneration Retinal Diseases

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ALK-001 (No generic name)

Drug

Daily, oral administration of ALK-001 capsules.

Other names: C20-D3-Retinyl Acetate, C20 Deuterated vitamin A

Primary outcomes

Safety of 4-week daily dosing of ALK-001 in healthy adults.

Time frame: 4 weeks

Safety evaluations combine: adverse events (AE), laboratory testing (hematology and biochemistry panels), 12-lead electrocardiograms (ECGs), vital signs, physical examination, and visual function (visual acuity and a self-reported questionnaire).

Sponsors and collaborators

Lead sponsor

Alkeus Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2015
First posted: Sep 3, 2014
Registry last updated: Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed