Back to resultsPhase 1 Safety Study of ALK-001 in Healthy Volunteers
Primary Purpose
Stargardt Disease, Age-related Macular Degeneration, Other Retinal Dystrophies
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ALK-001 (No generic name)
Sponsored by
About this trial
This is an interventional basic science trial for Stargardt Disease
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ALK-001 capsules
Arm Description
Outcomes
Primary Outcome Measures
Safety of 4-week daily dosing of ALK-001 in healthy adults.
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02230228
First Posted
August 27, 2014
Last Updated
March 21, 2015
Sponsor
Alkeus Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02230228
Brief Title
Phase 1 Safety Study of ALK-001 in Healthy Volunteers
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 Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alkeus Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stargardt Disease, Age-related Macular Degeneration, Other Retinal Dystrophies
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ALK-001 capsules
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ALK-001 (No generic name)
Other Intervention Name(s)
C20-D3-Retinyl Acetate, C20 Deuterated vitamin A
Intervention Description
Daily, oral administration of ALK-001 capsules.
Primary Outcome Measure Information:
Title
Safety of 4-week daily dosing of ALK-001 in healthy adults.
Description
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).
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonide Saad, PhD
Organizational Affiliation
Alkeus Pharmaceuticals, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ilyas Washington, PhD
Organizational Affiliation
Columbia University
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Phase 1 Safety Study of ALK-001 in Healthy Volunteers
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