Phase 1 Safety Study of ALK-001 in Healthy Volunteers (NCT02230228) | Clinical Trial Compass
CompletedPhase 1
Phase 1 Safety Study of ALK-001 in Healthy Volunteers
40 participantsStarted 2014-04
Plain-language 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.
Who can participate
Age range21 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Safety of 4-week daily dosing of ALK-001 in healthy adults.