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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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30 March 2015 |
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Main ID: |
NCT02230228 |
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Date of registration:
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27/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase 1 Safety Study of ALK-001 in Healthy Volunteers
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Scientific title:
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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 |
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Date of first enrolment:
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April 2014 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02230228 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Phase:
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Phase 1
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Contacts
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Name:
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Leonide Saad, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Alkeus Pharmaceuticals, Inc. |
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Name:
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Ilyas Washington, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Columbia University |
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Key inclusion & exclusion criteria
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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.
Age minimum:
21 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Age-related Macular Degeneration
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Other Retinal Dystrophies
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Stargardt Disease
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Intervention(s)
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Drug: ALK-001 (No generic name)
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Primary Outcome(s)
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Safety of 4-week daily dosing of ALK-001 in healthy adults.
[Time Frame: 4 weeks]
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Secondary ID(s)
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ALK001-P1001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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