- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02230228
Phase 1 Safety Study of ALK-001 in Healthy Volunteers
March 21, 2015 updated by: Alkeus Pharmaceuticals, Inc.
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ALK-001 capsules
|
Daily, oral administration of ALK-001 capsules.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Leonide Saad, PhD, Alkeus Pharmaceuticals, Inc.
- Study Chair: Ilyas Washington, PhD, Columbia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
August 27, 2014
First Submitted That Met QC Criteria
September 2, 2014
First Posted (Estimate)
September 3, 2014
Study Record Updates
Last Update Posted (Estimate)
March 24, 2015
Last Update Submitted That Met QC Criteria
March 21, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Genetic Diseases, Inborn
- Eye Diseases, Hereditary
- Macular Degeneration
- Retinal Dystrophies
- Stargardt Disease
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Protective Agents
- Micronutrients
- Adjuvants, Immunologic
- Vitamins
- Anticarcinogenic Agents
- Vitamin A
- Retinol acetate
Other Study ID Numbers
- ALK001-P1001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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