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Phase 1 Safety Study of ALK-001 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alkeus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02230228
First received: August 27, 2014
Last updated: March 21, 2015
Last verified: March 2015
  Purpose
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 Intervention Phase
Stargardt Disease Age-related Macular Degeneration Other Retinal Dystrophies Drug: ALK-001 (No generic name) Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Alkeus Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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).


Enrollment: 40
Study Start Date: April 2014
Study Completion Date: February 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02230228

Sponsors and Collaborators
Alkeus Pharmaceuticals, Inc.
Investigators
Study Director: Leonide Saad, PhD Alkeus Pharmaceuticals, Inc.
Study Chair: Ilyas Washington, PhD Columbia University
  More Information

Responsible Party: Alkeus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02230228     History of Changes
Other Study ID Numbers: ALK001-P1001
Study First Received: August 27, 2014
Last Updated: March 21, 2015

Additional relevant MeSH terms:
Macular Degeneration
Retinal Dystrophies
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 28, 2017