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Phase 1 Safety Study of ALK-001 in Healthy Volunteers

Sponsor
Alkeus Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02230228
Collaborator
(none)
40
Enrollment
1
Arm
10.1
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: ALK-001 (No generic name)
 Phase 1

Study Design

Study Type:
Interventional
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 :
Apr 1, 2014
Actual Primary Completion Date :
Sep 1, 2014
Actual Study Completion Date :
Feb 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 70 Years
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Alkeus Pharmaceuticals, Inc.

    Investigators

    • Study Director: Leonide Saad, PhD, Alkeus Pharmaceuticals, Inc.
    • Study Chair: Ilyas Washington, PhD, Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alkeus Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT02230228
    Other Study ID Numbers:
    • ALK001-P1001
    First Posted:
    Sep 3, 2014
    Last Update Posted:
    Mar 24, 2015
    Last Verified:
    Mar 1, 2015
    Additional relevant MeSH terms:
    Macular Degeneration
    Retinal Dystrophies
    Stargardt Disease
    Vitamin A
    Retinol acetate

    Study Results

    No Results Posted as of Mar 24, 2015