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Phase 1 Safety Study of ALK-001 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02230228
Recruitment Status : Completed
First Posted : September 3, 2014
Last Update Posted : March 24, 2015
Information provided by (Responsible Party):
Alkeus Pharmaceuticals, Inc.

Brief Summary:
This protocol is a phase 1 clinical study to assess the safety and pharmacokinetics of ALK-001 in healthy volunteers. Please contact for any questions.

Condition or disease Intervention/treatment Phase
Stargardt Disease Age-related Macular Degeneration Other Retinal Dystrophies Drug: ALK-001 (No generic name) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official 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
Study Start Date : April 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : February 2015

Arm Intervention/treatment
Experimental: ALK-001 capsules Drug: ALK-001 (No generic name)
Daily, oral administration of ALK-001 capsules.
Other Names:
  • C20-D3-Retinyl Acetate
  • C20 Deuterated vitamin A

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02230228

Sponsors and Collaborators
Alkeus Pharmaceuticals, Inc.
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Study Director: Leonide Saad, PhD Alkeus Pharmaceuticals, Inc.
Study Chair: Ilyas Washington, PhD Columbia University
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Responsible Party: Alkeus Pharmaceuticals, Inc. Identifier: NCT02230228    
Other Study ID Numbers: ALK001-P1001
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Dystrophies
Retinal Degeneration
Retinal Diseases
Eye Diseases
Vitamin A
Retinol acetate
Growth Substances
Physiological Effects of Drugs
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Adjuvants, Immunologic
Immunologic Factors