Title

Phase 1 Safety Study of ALK-001 in Healthy Volunteers
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
  • Phase

    Phase 1
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    alk-001 ...
  • Study Participants

    40
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 Started
Apr 30
2014
Primary Completion
Sep 30
2014
Study Completion
Feb 28
2015
Last Update
Mar 24
2015
Estimate

Drug ALK-001 (No generic name)

Daily, oral administration of ALK-001 capsules.

  • Other names: C20-D3-Retinyl Acetate, C20 Deuterated vitamin A

ALK-001 capsules Experimental

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.
No Results Posted